Proliferative retinopathy with diabetes mellitus

Initial real-world data from nearly 40,000 EYLEA HD patients will provide early insights on effectiveness of EYLEA HD in everyday clinical practice New indirect comparisons will evaluate EYLEA HD and faricimab on measures of efficacy, dosing frequency and potential economic benefits in patients with wet age-related macular degeneration and diabetic macular edema TARRYTOWN, N.Y., April 28, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the upcoming presentation of 27 abstracts, including eight oral presentations on EYLEA HD® (aflibercept) Injection 8 mg in wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR). Among the new results and analyses are initial insights on the real-world use of EYLEA HD in clinical practice, which reinforce the outcomes seen in pivotal trials. These data will be presented at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting from May 4 to 8 in Salt Lake City. "Our data presentations at ARVO reflect the robust and rapidly growing body of evidence that support the use of EYLEA HD becoming the new standard of care for people living with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy,” said Boaz Hirshberg, M.D., Senior Vice President, Clinical Development, Internal Medicine at Regeneron. “This includes new analyses examining the initial real-world experiences of nearly 40,000 patients treated with EYLEA HD showing, in everyday clinical practice, a positive impact through improved vision and longer dosing intervals for patients. Although early, these data reinforce the value EYLEA HD is bringing to patients with serious retinal diseases.” Notable new presentations at ARVO include: Four analyses evaluating initial real-world experiences with EYLEA HD among patients with wAMD or DME, including both those who were previously naive to treatment and those who switched from other anti-vascular endothelial growth factor (VEGF) therapiesA network meta-analysis indirectly comparing the efficacy and number of injections received for EYLEA HD and faricimab in patients with DME or wAMD, based on the longest follow-up data from Phase 3 clinical trialsA modeling analysis of the potential economic benefit of EYLEA HD compared to faricimab for the treatment of patients with wAMD or DME in the U.S. over three years The most common adverse reactions (≥3%) reported in patients treated with EYLEA HD were cataract, conjunctival hemorrhage, intraocular pressure increased, ocular discomfort/eye pain/eye irritation, vision blurred, vitreous floaters, vitreous detachment, corneal epithelium defect and retinal hemorrhage. Key EYLEA HD presentations at ARVO: Abstract titleLead author Presentation date, time (MST), locationEarly insights on the real-worlduse of aflibercept 8 mg amongtreatment-naive eyes withdiabetic macular edemaNitish Mehta, MDPoster PresentationDate: May 5Time: 3:00–4:45 PM MSTSession: Diabetic Macular Edema: Anti-VEGFEarly insights from real-worlduse of aflibercept 8 mg amongeyes with diabetic macularedema (DME) switching fromother anti-VEGF agentsMichael Javaheri, MDPoster PresentationDate: May 5Time: 3:00–4:45 PM MSTSession: Diabetic Macular Edema: Anti-VEGFEconomic benefit of aflibercept8 mg versus faricimab in thetreatment of patients withneovascular age-relatedmacular degeneration (nAMD)or diabetic macular edema(DME) in the United StatesAndreas KuznikPaper PresentationDate: May 5Time: 4:00–4:15 PM MSTSession: Economic Impact of AI Tools and TreatmentsEarly real-world use ofaflibercept 8mg in treatment-naïve patients with neovascularage-related maculardegenerationFerhina Ali, MDPoster PresentationDate: May 6Time: 8:30–10:15 AM MSTSession: AMD 2 (anti-VEGF)Early insights from real-worlduse of aflibercept 8mg amongeyes with neovascular age-related macular degeneration(nAMD) switching from otheranti-VEGF agentsTheodore Leng, MDPoster PresentationDate: May 6Time: 8:30–10:15 AM MSTSession: AMD 2 (anti-VEGF)Network meta-analyses (NMAs)of number of injections (NoI)with high-dose (HD) aflibercept(AFL) versus faricimab (FAR) inpatients with diabetic macularedema (DME) and neovascularage-related maculardegeneration (nAMD)Steven ShermanPoster PresentationDate: May 8 Time: 8:00–9:45 AM MSTSession: Telemedicine, Health Service Delivery and Health Economic StudiesVolumetric fluid assessmentcomparing high-dose afliberceptto standard dose aflibercept inneovascular age-relatedmacular degeneration in theCANDELA phase 2 trialJohn Mamone, MDPoster Presentation Date: May 4 Time: 1:00–2:45 PM MSTSession: AMD 1 (Clinical Research)PULSAR extension: clinicalimprovements maintained over156 weeks with aflibercept 8 mgin patients with neovascularage-related maculardegeneration*Timothy Lai, MDPaper PresentationDate: May 4Time: 1:00–1:15 PM MSTSession: AMD antiVEGF IA PULSAR phase 3 trial post-hoc analysis: evaluating thetiming and magnitude of controlof disease activity withaflibercept 8 mg and faricimab,applying similar disease activitycriteria across different pivotalPhase 3 trials for nAMD*Jean-Francois Korobelnik, MDPaper PresentationDate: May 4Time: 1:15–1:30 PM MSTSession: AMD antiVEGF ISPECTRUM: early clinicalexperience from the first globalreal-world study of aflibercept 8mg in patients with treatment-naïve neovascular age-relatedmacular degeneration*Vasileois Konidaris, MDPaper PresentationDate: May 4Time: 1:30–1:45 PM MSTSession: AMD antiVEGF ISPECTRUM: early clinicalexperience from the first globalreal-world study of aflibercept 8mg in patients with pretreatedneovascular age-relatedmacular degeneration*Clare Bailey, MDPaper PresentationDate: May 5Time: 3:00–3:15 PM MSTSession: AMD antiVEGF IIAflibercept 8 mg in diabeticmacular edema: 156-weekresults from the PHOTONextension studyGhassan Ghorayeb, MDPoster PresentationDate: May 5Time: 3:00–4:45 PM MSTSession: Retina: Physiology and PharmacologyIntraocular pressure outcomeswith aflibercept 8 mg and 2 mgin patients with diabetic macularedema through week 96 of thephase 2/3 PHOTON trialAnita Barikian, MDPoster PresentationDate: May 5 Time: 3:00–4:45 PM MSTSession: Diabetic Macular Edema: Anti-VEGFDifferential anatomic responseto aflibercept 8 mg versus 2 mgduring the matched dosingphase of the PHOTON trial inpatients with diabetic macularedema who subsequently metcriteria for shorteningDilsher Dhoot, MDPoster PresentationDate: May 5Time: 3:00–4:45 PM MSTSession: Diabetic Macular Edema: Anti-VEGFSPECTRUM: early clinicalexperience from the first globalreal-world study of aflibercept 8mg in patients with treatment-naïve diabetic macular edema*Aires Lobo, MDPoster PresentationDate: May 5Time: 3:00–4:45 PM MSTSession: Diabetic Macular Edema: Anti-VEGFSPECTRUM: early clinicalexperience from the first globalreal-world study of aflibercept 8mg in patients with pretreateddiabetic macular edema*Thomas Dervos, MDPoster Presentation:Date: May 5Time: 3:00–4:45 PM MSTSession: Diabetic Macular Edema: Anti-VEGFRapid fluid resolution withaflibercept 8 mg may beassociated with extended dosingintervals at W96 in nAMD: aPULSAR post-hoc analysis*Michael Stewart, MDPoster PresentationDate: May 6Time: 8:30–10:15 AM MSTSession: AMD 2 (anti-VEGF)Greater and more durable fluidresolution with aflibercept 8 mgversus aflibercept 2 mg in thePULSAR trial: a 96-week post-hoc analysis*Richard Gale, MDPoster PresentationDate: May 6Time: 8:30–10:15 AM MSTSession: AMD 2 (anti-VEGF)Clinical outcomes withaflibercept 8 mg and aflibercept2 mg are generally comparablein patients grouped by CNVtype: a post hoc analysis of the96-week PULSAR trial*Sobha Sivaprasad, MDPoster PresentationDate: May 6Time: 8:30–10:15 AM MSTSession: AMD 2 (anti-VEGF)A pooled analysis of theCANDELA, PHOTON, andPULSAR trials through 96weeks: comparably lowintraocular inflammation (IOI)-related events with aflibercept 8mg and 2 mg*Justus Garweg, MDPoster PresentationDate: May 6Time: 8:30–10:15 AM MSTSession: AMD 2 (anti-VEGF)Baseline characteristics andoutcomes of patients treatedwith aflibercept 8 mg atshortened, maintained, orextended dosing intervalsthrough 96 weeks in PHOTONMark Barakat, MDPaper PresentationDate: May 7Time: 11:15–11:30 AM MSTSession: Diabetic Macular Edema: Anti-VEGFWeek 96 outcomes inaflibercept 8 mg- and 2 mg-treated patients by prior DMEtreatment status: a subgroupanalysis of the phase 2/3PHOTON trialManjot Gill, MDPaper PresentationDate: May 7Time: 11:30–11:45 AM MSTSession: Diabetic Macular Edema: Anti-VEGFLower socioeconomic status isassociated with increasedbevacizumab use amongpatients initiating anti-vascularendothelial growth factor (anti-VEGF) therapy for diabeticmacular edema (DME)Judy Kim, MDPaper PresentationDate: May 7 Time: 11:45–12:00 PM MSTSession: Diabetic Macular Edema: Anti-VEGFA pooled analysis of thePULSAR and PHOTON trialsthrough 96 weeks: Minimalimpact of aflibercept 8 mg and 2mg on intraocular pressurechanges *Sergio Leal, MDPoster PresentationDate: May 8Time: 2:00–3:45 PM MSTSession: AMD 5 (Clinical Research) *Bayer-run trial About the EYLEA HD Clinical Trial Program PULSAR in wAMD and PHOTON in DME/diabetic retinopathy (DR) are double-masked, active-controlled pivotal trials that were conducted in multiple centers globally. In both trials, patients were randomized into 3 treatment groups to receive either: EYLEA HD every 3 months, EYLEA HD every 4 months, or EYLEA every 2 months. The lead sponsors of the trials were Bayer for PULSAR and Regeneron for PHOTON. Patients treated with EYLEA HD in both trials had 3 initial monthly doses, and patients treated with EYLEA received 3 initial doses in PULSAR and 5 in PHOTON. In the first year, patients in the EYLEA HD groups could have their dosing intervals shortened down to an every 2-month interval if protocol-defined criteria for disease progression were observed. Intervals could not be extended until the second year of the trial. Patients in all EYLEA groups maintained a fixed 2-month dosing regimen throughout their participation in the two-year trials. In both trials, there was an optional extension study starting at week 96, with all participating patients receiving EYLEA HD through week 156. Patients initially randomized to EYLEA in PULSAR, were switched to EYLEA HD at the start of the extension study and immediately assigned to a 3-month dosing interval. Dosing intervals for all patients in the extension study could be shortened or extended by 2-week increments if protocol-defined criteria were met, with a minimum dosing interval of every 2 months and a maximum dosing interval of every 6 months. CANDELA was a Regeneron-sponsored Phase 2 trial investigating the safety and efficacy of EYLEA HD extended dosing regimens compared to EYLEA in wAMD patients. About wAMD and Diabetic Eye Disease wAMD is a retinal disease that may affect people as they age. It occurs when abnormal blood vessels grow and leak fluid under the macula, the part of the eye responsible for sharp central vision and seeing fine detail. This fluid can damage and scar the macula, which can cause vision loss. An estimated 1.4 million Americans have wAMD. DR is an eye disease characterized by microvascular damage to the blood vessels in the retina often caused by poor blood sugar control in people with diabetes. The disease generally starts as nonproliferative diabetic retinopathy (NPDR) and often has no warning signs or symptoms. NPDR may progress to proliferative diabetic retinopathy (PDR), a stage of the disease in which abnormal blood vessels grow onto the surface of the retina and into the vitreous cavity, potentially causing severe vision loss. DME can occur at any stage of DR as the blood vessels in the retina become increasingly fragile and leak fluid, potentially causing visual impairment. In the U.S., approximately 1.5 million adults are diagnosed with DME, while approximately 6 million people have DR without DME. About EYLEA HD Over a decade ago, Regeneron introduced EYLEA, a vascular endothelial growth factor inhibitor, and transformed the treatment paradigm for certain serious chorioretinal vascular diseases. With a well-established efficacy and consistent safety profile from 16 pivotal trials, EYLEA is approved to treat vision-threatening conditions that impact patients from their earliest days, such as retinopathy of prematurity (ROP), to their later years, including diabetic macular edema (DME), diabetic retinopathy (DR), macular edema following retinal vein occlusion (RVO) and wet age-related macular degeneration (wAMD). Pushing the boundaries of science further to meet patient needs, EYLEA HD was developed to achieve comparable efficacy and safety to EYLEA, but with fewer injections. EYLEA HD is supported by a robust body of research and is currently approved in the U.S. to treat patients with wAMD, DME and DR. EYLEA HD (known as Eylea™ 8 mg in the European Union and Japan) is being jointly developed by Regeneron and Bayer AG. Regeneron maintains exclusive rights to EYLEA and EYLEA HD in the U.S. Bayer has licensed the exclusive marketing rights outside of the U.S., where the companies share equally the profits from sales of EYLEA and EYLEA HD. About Ophthalmology Development at Regeneron At Regeneron, we relentlessly pursue groundbreaking innovations in eye care science to help maintain the eye health of the millions of Americans impacted by vision-threatening conditions. Our expertise in angiogenesis and decades of research serve as our foundation, fueling our ongoing ambition to further innovate new solutions for patients. Our robust and diverse research and development program in ophthalmology includes efforts to potentially address additional serious eye diseases, including geographic atrophy (ongoing Phase 3 SIENNA clinical trial), glaucoma and certain inherited retinal diseases. IMPORTANT SAFETY INFORMATION AND INDICATIONS INDICATIONSEYLEA HD® (aflibercept) Injection 8 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). EYLEA® (aflibercept) Injection 2 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and Retinopathy of Prematurity (ROP) (0.4 mg). IMPORTANT SAFETY INFORMATION EYLEA HD and EYLEA are administered by injection into the eye. You should not use EYLEA HD or EYLEA if you have an infection in or around the eye, eye pain or redness, or known allergies to any of the ingredients in EYLEA HD or EYLEA, including aflibercept.Injections into the eye with EYLEA HD or EYLEA can result in an infection in the eye, retinal detachment (separation of retina from back of the eye) and, more rarely, serious inflammation of blood vessels in the retina that may include blockage. Call your doctor right away if you or your baby (if being treated with EYLEA for Retinopathy of Prematurity) experience eye pain or redness, light sensitivity, or a change in vision after an injection.In some patients, injections with EYLEA HD or EYLEA may cause a temporary increase in eye pressure within 1 hour of the injection. Sustained increases in eye pressure have been reported with repeated injections, and your doctor may monitor this after each injection.In infants with Retinopathy of Prematurity (ROP), treatment with EYLEA will need extended periods of ROP monitoring.There is a potential but rare risk of serious and sometimes fatal side effects, related to blood clots, leading to heart attack or stroke in patients receiving EYLEA HD or EYLEA.The most common side effects reported in patients receiving EYLEA HD were cataract, increased redness in the eye, increased pressure in the eye, eye discomfort, pain, or irritation, blurred vision, vitreous (gel-like substance) floaters, vitreous detachment, injury to the outer layer of the eye, and bleeding in the back of the eye.The most common side effects reported in patients receiving EYLEA were increased redness in the eye, eye pain, cataract, vitreous detachment, vitreous floaters, moving spots in the field of vision, and increased pressure in the eye.The most common side effects reported in pre-term infants with ROP receiving EYLEA were separation of the retina from the back of the eye, increased redness in the eye, and increased pressure in the eye. Side effects that occurred in adults are considered applicable to pre-term infants with ROP, though not all were seen in clinical studies.You may experience temporary visual changes after an EYLEA HD or EYLEA injection and associated eye exams; do not drive or use machinery until your vision recovers sufficiently.For additional safety information, please talk to your doctor and see the full Prescribing Information for EYLEA HD and EYLEA. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please click here for full Prescribing Information for EYLEA HD and EYLEA. About RegeneronRegeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X. Forward-Looking Statements and Use of Digital MediaThis press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation EYLEA HD® (aflibercept) Injection 8 mg; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products (such as EYLEA HD) and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron’s Products (such as EYLEA HD) and Regeneron’s Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron’s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; changes in laws, regulations, and policies affecting the healthcare industry; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates (including biosimilar versions of Regeneron’s Products); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection 2 mg), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2024. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals). Contacts:Media RelationsJulie BlockTel: +1 914-826-7083julie.block@regeneron.comInvestor RelationsMark HudsonTel: +1 914-847-3482mark.hudson@regeneron.com

Initial real-world data from nearly 40,000 EYLEA HD patients will provide early insights on effectiveness of EYLEA HD in everyday clinical practice New indirect comparisons will evaluate EYLEA HD and faricimab on measures of efficacy, dosing frequency and potential economic benefits in patients with wet age-related macular degeneration and diabetic macular edema TARRYTOWN, N.Y. , April 28, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the upcoming presentation of 27 abstracts, including eight oral presentations on EYLEA HD® (aflibercept) Injection 8 mg in wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR). Among the new results and analyses are initial insights on the real-world use of EYLEA HD in clinical practice, which reinforce the outcomes seen in pivotal trials. These data will be presented at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting from May 4 to 8 in Salt Lake City . "Our data presentations at ARVO reflect the robust and rapidly growing body of evidence that support the use of EYLEA HD becoming the new standard of care for people living with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy,” said Boaz Hirshberg , M.D., Senior Vice President, Clinical Development, Internal Medicine at Regeneron . “This includes new analyses examining the initial real-world experiences of nearly 40,000 patients treated with EYLEA HD showing, in everyday clinical practice, a positive impact through improved vision and longer dosing intervals for patients. Although early, these data reinforce the value EYLEA HD is bringing to patients with serious retinal diseases.” Notable new presentations at ARVO include: Four analyses evaluating initial real-world experiences with EYLEA HD among patients with wAMD or DME, including both those who were previously naive to treatment and those who switched from other anti-vascular endothelial growth factor (VEGF) therapies A network meta-analysis indirectly comparing the efficacy and number of injections received for EYLEA HD and faricimab in patients with DME or wAMD, based on the longest follow-up data from Phase 3 clinical trials A modeling analysis of the potential economic benefit of EYLEA HD compared to faricimab for the treatment of patients with wAMD or DME in the U.S. over three years The most common adverse reactions (≥3%) reported in patients treated with EYLEA HD were cataract, conjunctival hemorrhage, intraocular pressure increased, ocular discomfort/eye pain/eye irritation, vision blurred, vitreous floaters, vitreous detachment, corneal epithelium defect and retinal hemorrhage. Key EYLEA HD presentations at ARVO: *Bayer-run trial About the EYLEA HD Clinical Trial Program PULSAR in wAMD and PHOTON in DME/diabetic retinopathy (DR) are double-masked, active-controlled pivotal trials that were conducted in multiple centers globally. In both trials, patients were randomized into 3 treatment groups to receive either: EYLEA HD every 3 months, EYLEA HD every 4 months, or EYLEA every 2 months. The lead sponsors of the trials were Bayer for PULSAR and Regeneron for PHOTON. Patients treated with EYLEA HD in both trials had 3 initial monthly doses, and patients treated with EYLEA received 3 initial doses in PULSAR and 5 in PHOTON. In the first year, patients in the EYLEA HD groups could have their dosing intervals shortened down to an every 2-month interval if protocol-defined criteria for disease progression were observed. Intervals could not be extended until the second year of the trial. Patients in all EYLEA groups maintained a fixed 2-month dosing regimen throughout their participation in the two-year trials. In both trials, there was an optional extension study starting at week 96, with all participating patients receiving EYLEA HD through week 156. Patients initially randomized to EYLEA in PULSAR, were switched to EYLEA HD at the start of the extension study and immediately assigned to a 3-month dosing interval. Dosing intervals for all patients in the extension study could be shortened or extended by 2-week increments if protocol-defined criteria were met, with a minimum dosing interval of every 2 months and a maximum dosing interval of every 6 months. CANDELA was a Regeneron -sponsored Phase 2 trial investigating the safety and efficacy of EYLEA HD extended dosing regimens compared to EYLEA in wAMD patients. About wAMD and Diabetic Eye Disease wAMD is a retinal disease that may affect people as they age. It occurs when abnormal blood vessels grow and leak fluid under the macula, the part of the eye responsible for sharp central vision and seeing fine detail. This fluid can damage and scar the macula, which can cause vision loss. An estimated 1.4 million Americans have wAMD. DR is an eye disease characterized by microvascular damage to the blood vessels in the retina often caused by poor blood sugar control in people with diabetes. The disease generally starts as nonproliferative diabetic retinopathy (NPDR) and often has no warning signs or symptoms. NPDR may progress to proliferative diabetic retinopathy (PDR), a stage of the disease in which abnormal blood vessels grow onto the surface of the retina and into the vitreous cavity, potentially causing severe vision loss. DME can occur at any stage of DR as the blood vessels in the retina become increasingly fragile and leak fluid, potentially causing visual impairment. In the U.S. , approximately 1.5 million adults are diagnosed with DME, while approximately 6 million people have DR without DME. About EYLEA HD Over a decade ago, Regeneron introduced EYLEA, a vascular endothelial growth factor inhibitor, and transformed the treatment paradigm for certain serious chorioretinal vascular diseases. With a well-established efficacy and consistent safety profile from 16 pivotal trials, EYLEA is approved to treat vision-threatening conditions that impact patients from their earliest days, such as retinopathy of prematurity (ROP), to their later years, including diabetic macular edema (DME), diabetic retinopathy (DR), macular edema following retinal vein occlusion (RVO) and wet age-related macular degeneration (wAMD). Pushing the boundaries of science further to meet patient needs, EYLEA HD was developed to achieve comparable efficacy and safety to EYLEA, but with fewer injections. EYLEA HD is supported by a robust body of research and is currently approved in the U.S. to treat patients with wAMD, DME and DR. EYLEA HD (known as Eylea™ 8 mg in the European Union and Japan ) is being jointly developed by Regeneron and Bayer AG. Regeneron maintains exclusive rights to EYLEA and EYLEA HD in the U.S. Bayer has licensed the exclusive marketing rights outside of the U.S. , where the companies share equally the profits from sales of EYLEA and EYLEA HD. About Ophthalmology Development at Regeneron At Regeneron , we relentlessly pursue groundbreaking innovations in eye care science to help maintain the eye health of the millions of Americans impacted by vision-threatening conditions. Our expertise in angiogenesis and decades of research serve as our foundation, fueling our ongoing ambition to further innovate new solutions for patients. Our robust and diverse research and development program in ophthalmology includes efforts to potentially address additional serious eye diseases, including geographic atrophy (ongoing Phase 3 SIENNA clinical trial), glaucoma and certain inherited retinal diseases. IMPORTANT SAFETY INFORMATION AND INDICATIONS INDICATIONSEYLEA HD® (aflibercept) Injection 8 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). EYLEA® (aflibercept) Injection 2 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and Retinopathy of Prematurity (ROP) (0.4 mg). IMPORTANT SAFETY INFORMATION EYLEA HD and EYLEA are administered by injection into the eye. You should not use EYLEA HD or EYLEA if you have an infection in or around the eye, eye pain or redness, or known allergies to any of the ingredients in EYLEA HD or EYLEA, including aflibercept. Injections into the eye with EYLEA HD or EYLEA can result in an infection in the eye, retinal detachment (separation of retina from back of the eye) and, more rarely, serious inflammation of blood vessels in the retina that may include blockage. Call your doctor right away if you or your baby (if being treated with EYLEA for Retinopathy of Prematurity) experience eye pain or redness, light sensitivity, or a change in vision after an injection. In some patients, injections with EYLEA HD or EYLEA may cause a temporary increase in eye pressure within 1 hour of the injection. Sustained increases in eye pressure have been reported with repeated injections, and your doctor may monitor this after each injection. In infants with Retinopathy of Prematurity (ROP), treatment with EYLEA will need extended periods of ROP monitoring. There is a potential but rare risk of serious and sometimes fatal side effects, related to blood clots, leading to heart attack or stroke in patients receiving EYLEA HD or EYLEA. The most common side effects reported in patients receiving EYLEA HD were cataract, increased redness in the eye, increased pressure in the eye, eye discomfort, pain, or irritation, blurred vision, vitreous (gel-like substance) floaters, vitreous detachment, injury to the outer layer of the eye, and bleeding in the back of the eye. The most common side effects reported in patients receiving EYLEA were increased redness in the eye, eye pain, cataract, vitreous detachment, vitreous floaters, moving spots in the field of vision, and increased pressure in the eye. The most common side effects reported in pre-term infants with ROP receiving EYLEA were separation of the retina from the back of the eye, increased redness in the eye, and increased pressure in the eye. Side effects that occurred in adults are considered applicable to pre-term infants with ROP, though not all were seen in clinical studies. You may experience temporary visual changes after an EYLEA HD or EYLEA injection and associated eye exams; do not drive or use machinery until your vision recovers sufficiently. For additional safety information, please talk to your doctor and see the full Prescribing Information for EYLEA HD and EYLEA. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please click here for full Prescribing Information for EYLEA HD and EYLEA. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X. Forward-Looking Statements and Use of Digital MediaThis press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation EYLEA HD® (aflibercept) Injection 8 mg; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products (such as EYLEA HD) and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates; safety issues resulting from the administration of Regeneron’s Products (such as EYLEA HD) and Regeneron’s Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement of Regeneron’s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; changes in laws, regulations, and policies affecting the healthcare industry; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates (including biosimilar versions of Regeneron’s Products); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron 's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts ), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection 2 mg), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission , including its Form 10-K for the year ended December 31, 2024 . Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron . Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron 's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals). Source: Regeneron Pharmaceuticals, Inc.

PALO ALTO, Calif., March 27, 2025 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), today reported recent business highlights and financial results for the fourth quarter and full year ended December 31, 2024. "In September of 2024 we hosted an Investor R&D Day in New York," said Victor Perlroth, M.D., Chief Executive Officer of Kodiak Sciences. "The Investor R&D Day webcast and presentation featured scientific, clinical and commercial perspectives and included key retina opinion leaders. It was an important snapshot of where we stood at that time, and where we were going – we called it Kodiak 2.0. Six months later, we are well on track." "It is remarkable that after twenty years of anti-VEGF therapy, retinal commercial franchises continue to be a major driver of revenue and profitability within large pharma companies. This sustained commercial success is a testament to the power of the intravitreal biologic as the mainstay of therapy and also a testament to the unmet need that remains for patients. First generation agents clearly do not do it well enough, and the newer agents notwithstanding their commercial success are deemed incremental improvements by retina opinion leaders who call them Generation 1.5. The core unmet need remains unfulfilled – to control the disease with both (1) immediacy and (2) durability. Improvement in either one is useful. Definitive improvement in both –at the same time, in the same therapy– is the promise and potential of Kodiak 2.0." "We have two strong contenders in this anti-VEGF category, tarcocimab and KSI-501. Both are built with our ABC® platform, where our enhanced formulation is intended to bring a strong pulse of anti-VEGF to power immediacy of effect and our antibody conjugate is designed to bring a true science of durability to power long-interval dosing." "With tarcocimab, we have two new Phase 3 studies in progress. Both GLOW2 and DAYBREAK are designed to enhance their probability of success, as they build on learnings from our prior studies. GLOW2 has completed enrollment, and we are on a trajectory to announce topline data in 1Q 2026. We expect to complete DAYBREAK enrollment shortly, such that we expect to be on a trajectory to announce topline data in 2Q 2026. Therefore, we remain well on track towards our goal of a single BLA filing in 2026 in the three large indications of wet AMD, retinal vein occlusion and diabetic retinopathy." "With KSI-501 and its dual mechanism of action, we are exploring in the same Phase 3 DAYBREAK study the ability for KSI-501 to show a differentiated efficacy versus the active comparator aflibercept. As DAYBREAK evolves, we will be considering what regulatory pathway might result in the most time efficient and broadest sets of indications with the highest probability of success towards a KSI-501 BLA filing." "With KSI-101, we have broadened our focus into a greenfield opportunity in retina, the macular edema inflammation market. Intraocular inflammation is the fourth leading cause of vision loss for working aged adults in the developed world. One-third of patients with intraocular inflammation develop macular edema, which is the leading cause of vision loss among patients with intraocular inflammation. In the United States, this population of macular edema and inflammation is more than 100,000 patients, and today these patients have no approved therapy other than steroids. We believe there is a commercial opportunity and high unmet need for a powerful, safe, local, biologic therapy such as KSI-101, which is a traditional (unconjugated) intravitreal biologic targeting two underlying mechanisms of disease and which has the potential to be disease-modifying." "With KSI-101, we initiated the APEX Phase 1b clinical study in the first half of 2024 in patients with diabetic macular edema (DME) and patients with macular edema secondary to inflammation (MESI). We announced data on the three lead MESI patients in January at the JP Morgan conference. In June, we plan to share data that we believe supports the potential for KSI-101 to be a cornerstone therapy for these patients in need. To date, we remain very pleased with the continued evolution of the data, and we expect in 2Q 2025 to initiate our pivotal study in patients with MESI." "Deeper in our pipeline, our ABC® platform science continues to advance a next set of investigational therapies for high prevalence retinal diseases that are intended to address two key technical barriers for locally administered retinal medicines: (1) ocular durability for small Active Pharmaceutical Intermediates (API) such as small molecule drugs and peptides, and (2) multi-functional mechanisms of action in a single therapy. We continue to advance our duet technology, looking to novel, durable and multifunctional therapies for glaucoma (>75 million patients worldwide) and geographic atrophy (>5 million patients worldwide)." "We also continue to advance our VETi (Visual Engagement Technology and imager) program. VETi is built on Kodiak's suite of proprietary LiDAR (Light Detection and Ranging) sensor technologies. VETi is an autonomous AI- and machine-learning-enabled headset that engages directly into the eye. Our goal is to commercialize VETi together with Kodiak's emerging portfolio of retinal medicines using apps that apply AI-enabled tools. We also believe VETi has future potential to build correlations between VETi data and many human diseases outside of retina. VETi may also have future potential as an AI-enabled device with similarities to a consumer smartwatch but with direct access into the body and the brain through the eye rather than through the skin." Recent Business Highlights and Upcoming Catalysts We plan to host an Investor R&D Update in June 2025. At that time, we anticipate sharing more information about our recent accomplishments, and we also expect to be in a position to announce the following business highlights: Tarcocimab: Phase 3 GLOW2 diabetic retinopathy study - enrollment completed with expected timeline to topline data in 1Q2026 Phase 3 DAYBREAK wet AMD study - enrollment completed with expected timeline to topline data in 2Q2026 KSI-501: Phase 3 DAYBREAK wet AMD study - enrollment completed with expected timeline to topline data in 2Q2026 KSI-101: FDA Orphan Drug Designation received Release of new APEX Phase 1b multiple dose clinical trial data for KSI-101 Extrapolation of APEX multiple dose data to Phase 2b/3 study design and probability of success Phase 2b/3 trial initiated Clinical and regulatory plan with expected timeline to topline primary endpoint data in 2026 Briefing on commercial opportunity Fourth Quarter and Full Year 2024 Financial Results Cash Position Kodiak ended the fourth quarter of 2024 with $168.1 million of cash and cash equivalents. We believe that our current cash will support our current and planned operations into 2026. Net Loss The net loss for the fourth quarter of 2024 was $44.1 million, or $0.84 per share on both a basic and diluted basis, as compared to a net loss of $59.5 million, or $1.13 per share on both a basic and diluted basis, for the fourth quarter of 2023. The net loss for the quarter ended December 31, 2024 included non-cash stock-based compensation of $8.6 million, as compared to $22.8 million for the quarter ended December 31, 2023. R&D Expenses Research and development ("R&D") expenses were $31.8 million for the quarter ended December 31, 2024, as compared to $46.6 million for the quarter ended December 31, 2023. The R&D expenses for the fourth quarter of 2024 included non-cash stock-based compensation of $0.2 million, as compared to $11.9 million for the fourth quarter of 2023. The decrease in R&D expenses for the fourth quarter of 2024 was primarily driven by reduced manufacturing activities and forfeitures of equity awards, partially offset by clinical activities from active trials. R&D expenses were $126.1 million for the year ended December 31, 2024, as compared to $206.3 million for the year ended December 31, 2023. The R&D expenses for the full year of 2024 included non-cash stock-based compensation of $24.2 million, as compared to $44.0 million for the full year of 2023. The decrease in R&D expenses for the full year of 2024 was primarily driven by decreased clinical activities for completed trials and forfeitures of equity awards, partially offset by costs from active clinical trials for the tarcocimab development program as well as expanding clinical activities for KSI-501 and KSI-101. G&A Expenses General and administrative ("G&A") expenses were $14.4 million for the quarter ended December 31, 2024, as compared to $16.7 million for the quarter ended December 31, 2023. The G&A expenses for the fourth quarter of 2024 included non-cash stock-based compensation of $8.4 million, as compared to $10.9 million for the fourth quarter of 2023. G&A expenses were $60.8 million for the year ended December 31, 2024, as compared to $71.0 million for the year ended December 31, 2023. The G&A expenses for the full year of 2024 included non-cash stock-based compensation of $36.1 million, as compared to $44.5 million for the full year of 2023. The decrease in G&A expenses for the full year of 2024 was primarily driven by stock-based compensation expense related to previously issued awards becoming fully vested. About Tarcocimab Tarcocimab is an investigational anti-VEGF therapy built on Kodiak's proprietary Antibody Biopolymer Conjugate ("ABC") Platform and is designed to maintain potent and effective drug levels in ocular tissues for longer than existing available agents. Tarcocimab is being developed as a mainstay intravitreal biologic monotherapy that provides high immediacy, driven by the enhanced formulation, and high durability, driven by the ABC® platform and our science of durability, with the ultimate objective of providing, once approved, a flexible 1-month through 6-month label for all patients with retinal vascular disease (treatment-naïve, treatment-experienced, mild patients, severe patients). To date, tarcocimab has completed three successful Phase 3 pivotal clinical studies: the Phase 3 GLOW1 study in diabetic retinopathy ("DR"), the Phase 3 BEACON study in retinal vein occlusion ("RVO") and the Phase 3 DAYLIGHT study in wet AMD. In the GLOW1 study, tarcocimab successfully treated DR patients and prevented disease progression with 100% of patients on extended 6-month dosing. In the BEACON study, in the first 6 months tarcocimab-treated patients were dosed on every 8-week interval (as opposed to every 4-week interval for aflibercept) and in the second 6 months nearly half of tarcocimab patients did not require any treatment while achieving similar vision and anatomical outcomes as the aflibercept group at one year. Tarcocimab is currently being studied in two Phase 3 clinical trials, the GLOW2 study in DR and the DAYBREAK study in wet AMD. GLOW2 has completed enrollment and DAYBREAK is actively enrolling. The GLOW2 study design mirrors that of our successful GLOW1 study in DR, with the advantage of a third monthly loading dose (baseline, Week 4, Week 8) to provide dosing flexibility to providers. All patients randomized to investigational therapy will receive tarcocimab on extended, 6-month dosing. Both GLOW2 and DAYBREAK use tarcocimab's enhanced 50 mg/mL formulation containing both conjugated and unconjugated antibody that is intended to balance immediacy and durability. About GLOW1 (complete) and GLOW2 (ongoing): The Phase 3 GLOW1 demonstrated that with extended 6-month dosing in every patient, tarcocimab can achieve strong efficacy both in treating existing disease (primary endpoint) and preventing vision threatening complications and disease progression (key secondary endpoint). In GLOW1, tarcocimab met its primary endpoint of the proportion of patients with at least a 2-step improvement on the Diabetic Retinopathy Severity Scale ("DRSS") score with 41.1% of tarcocimab-treated patients demonstrating at least a 2-step improvement vs. 1.4% of patients in the sham group, a 29-fold increased response rate ratio (p-value less than 0.0001). Tarcocimab also met all key secondary endpoints, including greater reductions in the proportion of patients developing sight-threatening complications (such as diabetic macular edema and proliferative diabetic retinopathy), versus sham, demonstrating an 89% decreased risk, achieving 21.0% versus 2.3% (p-value less than 0.0001). Tarcocimab also showed a 95% risk reduction in the development of DME, versus sham, from 13.7% on sham versus 0.7% on tarcocimab. The Phase 3 GLOW2 study is a prospective, randomized, double-masked, multi-center pivotal superiority study designed to evaluate the efficacy and safety of tarcocimab tedromer in treatment-naïve patients with DR. Patients are randomized 1:1 and receive either sham injections or tarcocimab via intravitreal injection at baseline, Week 4, Week 8, Week 20 and Week 44. The primary endpoint is the proportion of eyes improving ≥2 steps on Diabetic Retinopathy Severity Scale ("DRSS") from baseline at Week 48. Additional outcome measures include the proportion of eyes developing a sight threatening complication of diabetic retinopathy and the proportion of eyes improving ≥3 steps on DRSS from baseline at Week 48. Additional information about GLOW2 (also called Study KS301P108) can be found on under Trial Identifier NCT06270836 (). About DAYBREAK and tarcocimab: The Phase 3 DAYBREAK study is a non-inferiority study evaluating parallel investigational arms of tarcocimab and KSI-501 against active comparator aflibercept. The DAYBREAK study incorporates learnings from prior pivotal trials of tarcocimab and was designed to maximize the probability of meeting the primary endpoint of non-inferiority in visual acuity gains. Patients randomized to tarcocimab will receive individualized dosing every 4 to 24 weeks on an as needed basis following four monthly loading doses. Patients randomized to aflibercept will be dosed per label. The individualized dosing of tarcocimab is determined by a treat-to-dryness proactive approach using presence of retinal fluid as a disease activity marker, which resembles retina specialists' practice and optimizes each patient's treatment instead of a combination of central subfield thickness ("CST") and vision loss. The objectives for tarcocimab in DAYBREAK are to assess its 6-month durability potential, strengthen its competitive position in wet AMD and bolster the possible regulatory application package for the program. In particular, we hope DAYBREAK will allow tarcocimab to showcase its potential to be a mainstay biologic for VEGF-driven retinal vascular diseases that has both strong efficacy/immediacy driven by its enhanced formulation, and strong durability driven by its ABC® design and science of durability. About KSI-501 KSI-501 is an investigational anti-IL-6, VEGF-trap bispecific therapy built on the ABC platform and is being developed for high prevalence retinal vascular diseases to address the leading unmet needs of extended durability and targeting disease biology beyond VEGF for differentiated efficacy. KSI-501 is designed to provide high immediacy/efficacy, driven by the enhanced formulation, and high durability, driven by the ABC® platform and our science of durability. In preclinical models, KSI-501 was shown to be a potent inhibitor of VEGF and IL-6 and, further, was shown to normalize the blood retinal barrier, opening up the possibility that KSI-501 may be a disease-modifying therapy for retinal vascular diseases. Furthermore, higher intraocular levels of IL-6 correlated with poorer BCVA outcomes over time in wet AMD patients treated with anti-VEGF monotherapy, which suggests that IL-6 inhibition in combination with anti-VEGF therapy could lead to improved outcomes. A completed Phase 1 multiple ascending dose study demonstrated that repeated monthly dosing of KSI-501 was well tolerated and achieved clinically meaningful and sustained improvement in visual acuity and fluid reduction in patients with diabetic macular edema. Kodiak has advanced KSI-501 into a Phase 3 study DAYBREAK to evaluate its efficacy and safety in wet AMD. DAYBREAK is actively enrolling patients. DAYBREAK uses KSI-501's enhanced 50 mg/mL formulation containing both conjugated and unconjugated antibody that is intended to balance immediacy and durability. About DAYBREAK and KSI-501: The DAYBREAK study is a non-inferiority study evaluating parallel investigational arms of KSI-501 and tarcocimab against active comparator aflibercept. Patients randomized to KSI-501 will receive fixed every 8-week dosing with additional individualized dosing (up to monthly dosing) on an as needed basis after 4 monthly loading doses. Patients randomized to aflibercept will be dosed per label. Using the same treat-to-dryness approach as tarcocimab, coupled with fixed intensive proactive dosing, our goal is to maximize both the probability of meeting the primary endpoint as well as the probability of demonstrating additional efficacy benefits. The primary endpoint is non-inferiority in change in visual acuity from baseline to the average of Week 40, 44 and 48. The objective for KSI-501 in DAYBREAK is to explore the efficacy potential of bispecific VEGF and IL-6 inhibition in a broad treatment-naïve wet AMD population. DAYBREAK is now actively enrolling patients. Additional information about DAYBREAK can be found on under Trial Identifier NCT06556368 (). About KSI-101 KSI-101 is a novel, potent and high strength (100 mg/mL) bispecific protein targeting IL-6 and VEGF, which is a "traditional" (unconjugated) intravitreal biologic. We are developing KSI-101 for patients who have retinal fluid and inflammation. Currently there are no available intravitreal biologic therapies addressing the spectrum of inflammatory conditions of the retina. We believe that retinal inflammatory conditions represent a new market segment separate from the established anti-VEGF market. KSI-101 is a clinical prospect with opportunities and risks uncoupled from the ABC Platform, and as such we believe it is an important part of our portfolio. We continue to enroll patients in our dose-finding Phase 1b study APEX. The APEX study evaluates KSI-101 in two cohorts, Cohort 1 in patients with diabetic macular edema ("DME") and Cohort 2 in patients with macular edema secondary to inflammation ("MESI"). The goal of the APEX study is to evaluate the safety and tolerability of KSI-101 and to identify two dose levels to progress into dual Phase 2b/3 studies (PEAK and PINNACLE) in MESI. About the ABC® Platform Pipeline Program: We are expanding our research pipeline of duets and triplets built from our modular ABC® Platform that embeds diverse active pharmaceutical ingredients ("API") including small molecules, proteins, peptides, macrocycles, and oligonucleotides in the biopolymer backbone to enable high drug antibody ratio ("DAR") medicines with targeted, multi-specific, tailored modulation of biological pathways for ophthalmic and systemic diseases. One program is for the treatment of glaucoma, embedding in the biopolymer backbone (i) an NLRP3 small molecule inhibitor, and (ii) a second small molecule that lowers intraocular pressure ("IOP"). The NLRP3 inflammasome is an intracellular complex that drives inflammation and cell death and is known to play a key role in glaucoma progression. The goal of this program is to create an intravitreally injected therapy that delivers two mechanisms of action ("MOA") in a sustained release fashion, to fulfill the unmet needs in the glaucoma field for non-topical, long-durability therapy that delivers MOAs beyond IOP lowering. The second program is for the treatment of geographic atrophy. There are currently two approved therapies, both complement inhibitors, for geographic atrophy ("GA"), the advanced stage of dry AMD. These therapies require monthly or every other month intravitreal injections and neither sufficiently halts disease progression. This program at Kodiak explores the potential to embed in the biopolymer backbone (i) a macrocyclic peptide inhibitor of the complement pathway, and (ii) an NLRP3 small molecule inhibitor. The NLRP3 inflammasome is known to play a key role in AMD disease biology. The objective of this program is to create an intravitreally injected ABC® platform-enabled therapy with a dual mechanism of action to achieve better efficacy and extended durability as compared to currently approved therapies for GA. About Visual Engagement Technology and Imager (VETi) We are developing VETi designed by Kodiak engineers initially to be used by eye care professionals for vision and ophthalmic anatomical examination, diagnosis and monitoring. Our longer-term goal with VETi, built with innovative technology, such as LiDAR in the eye, is to deliver a self-operated wearable device that captures high-quality, retina-grade data and utilizes the power of AI and machine learning for long-term health engagement and monitoring for both ophthalmic and systemic conditions. We are designing VETi with the intent to disrupt future ophthalmology clinical trials by enabling new trial endpoints, thereby enabling faster and more cost-effective medicines development in ophthalmic disease, an area that historically requires lengthy and expensive trials. VETi may also aid in market build and shaping for undertreated or underdiagnosed diseases, such as diabetic eye diseases where Kodiak's product candidates tarcocimab and KSI-501 are being studied and where early treatment and prevention may allow patients to achieve better outcomes. About Kodiak Sciences Inc. Kodiak Sciences (Nasdaq: KOD) is a biopharmaceutical company committed to researching, developing, and commercializing transformative therapeutics to treat a broad spectrum of retinal diseases. We are focused on bringing new science to the design and manufacture of next generation retinal medicines to prevent and treat the leading causes of blindness globally. Our ABC Platform™ uses molecular engineering to merge the fields of protein-based and chemistry-based therapies and has been at the core of Kodiak's discovery engine. We are developing a portfolio of three clinical programs, two of which are late-stage today and derived from our ABC Platform and one which is platform-independent and which we believe can progress rapidly into pivotal studies. For more information, please visit . Kodiak®, Kodiak Sciences®, ABC®, ABC Platform™, ABCD™ and the Kodiak logo are registered trademarks or trademarks of Kodiak Sciences Inc. in various global jurisdictions. Forward-Looking Statements This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding: the promise and potential of Kodiak 2.0; the potential benefits of tarcocimab and KSI-501; the enhanced formulation's ability to bring immediacy of effect and high durability; the probability of success of GLOW2 and DAYBREAK; the timing of GLOW2 topline data; the expected completion of DAYBREAK enrollment and timing of announcement of topline data; a potential BLA filing in 2026 in the three large indications of wet AMD, retinal vein occlusion and diabetic retinopathy; the ability for KSI-501 to show a differentiated efficacy versus the active comparator aflibercept; the regulatory pathway and potential BLA filing for KSI-501; the commercial opportunity and high unmet need for KSI-101; plans to share data that supports the potential for KSI-101 to be a cornerstone therapy; the expected timing to initiate dosing in the KSI-101pivotal study in patients with MESI; the ABC® platform science continuing to advance a next set of investigational therapies for high prevalence retinal diseases; the advancement of duet and triplet technology; the advancement of the VETi program and its potential commercialization with the emerging portfolio of retinal medicines; VETi's future potential to build correlations between VETi data and human diseases outside of retina; the longer-term goal of VETi to deliver a self-operated wearable device; the potential for VETi to disrupt future ophthalmology clinical trials by enabling new trial endpoints; anticipated highlights to be shared in an Investor R&D update in June 2025; anticipated highlights with respect to KSI-101, including clinical and regulatory plans and timing of topline data; the ultimate objective of tarcocimab to provide a flexible 1-month through 6-month label for all patients with retinal vascular disease; tarcocimab's potential to achieve strong efficacy both in treating existing disease and preventing vision threatening complications and disease progression; and guidance on cash runway. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "could," "expect," "plan," "believe," "intend," "pursue," and other similar expressions among others. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. The risks and uncertainties include, but are not limited to: the risk that cessation or delay of any of the on-going clinical studies and our development of tarcocimab, KSI-501 or KSI-101 may occur; the risk that results of our clinical studies may not provide the evidence, insights, or benefits as anticipated; the risk that safety, efficacy, and durability data observed in our product candidates in current or prior studies may not continue or persist; the risk that the results of the tarcocimab Phase 3 studies may not be sufficient to support a single BLA submission for wet AMD, retinal vein occlusion and diabetic retinopathy; the risk that a BLA may not be accepted by, or receive approval from, the FDA or foreign regulatory agencies when expected, or at all; future potential regulatory milestones of tarcocimab or KSI-501 or KSI-101, including those related to current and planned clinical studies, may be insufficient to support regulatory submissions or approval; the risk that our research and development efforts and our ability to advance our product candidates into later stages of development may fail; any one or more of our product candidates may not be successfully developed, approved or commercialized; our manufacturing facilities may not operate as expected; adverse conditions in the general domestic and global economic markets, which may significantly impact our business and operations, including our clinical trial sites, as well as the business or operations of our manufacturers, contract research organizations or other third parties with whom we conduct business; as well as the other risks identified in our filings with the Securities and Exchange Commission. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in our most recent Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and Kodiak undertakes no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements. Kodiak®, Kodiak Sciences®, ABC®, ABC Platform™, ABCD™ and the Kodiak logo are registered trademarks or trademarks of Kodiak Sciences Inc. in various global jurisdictions. SOURCE Kodiak Sciences Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED