A Randomized, Double-Masked, Sham-Controlled Clinical Trial of Intravitreal Faricimab for Chronic Central Serous Chorioretinopathy With or Without Secondary Macular Neovascularization: Study Protocol for a Randomised, Double-Masked Trial

Dysregulation of the Angiopoietin-2 (Ang-2)/Tyrosine kinase with Immunoglobulin-like and EGF-like domains 2 (Tie-2) signaling pathway has been implicated in choroidal vascular instability and RPE dysfunction in Central serous chorioretinopathy (CSCR) and pachychoroid-associated neovascularization.
This study prospectively evaluates the efficacy and safety of faricimab compared to sham in CSCR with and without secondary neovascularization, using standardized anatomical and functional endpoints. The results of this trial may help define the role of dual pathway inhibition in CSCR and inform future treatment strategies for this challenging and vision threatening condition.

Start Date01 Dec 2026

Sponsor / Collaborator

Singapore National Eye Centre Pte Ltd.

[+1]

NCT07753616

/ Not yet recruitingPhase 4IIT

South Asian Patients With Diabetic Macular Oedema Treated With Faricimab Assessing the Efficacy, Durability, and Safety (SEAFAR Study)

The YOSEMITE and RHINE trials, which studied DMO treated with faricimab, had a majority Caucasian cohort, and the small Asian cohort was East Asian, with no South Asian representation. South Asians have a much higher prevalence of diabetes and its ophthalmic complication of DMO.
The SEAFAR study is designed to address this unmet need by specifically evaluating faricimab in a UK-based South Asian cohort with diabetic macular oedema (DMO), delivered via a pragmatic treat-and-extend regimen, for clinically meaningful visual acuity gains, durable anatomic control of DMO, and an acceptable safety profile at week 88 in South Asian patients, with interim benefits by week 52.

Start Date01 Nov 2026

Sponsor / Collaborator-

NCT07695298

/ RecruitingPhase 4IIT

A Prospective Longitudinal Analysis of Faricimab (Vabysmo 6mg) For Choroidal Neovascularization in Presumed Ocular Histoplasmosis Syndrome [PLANE Study]

This study will evaluate the safety and effects, good or bad of faricimab (Vabysmo®), a drug that is approved by the U.S. Food and Drug Administration (FDA) for other retinal conditions, but its use is considered investigational when used specifically for choroidal neovascularization (CNV) related to presumed ocular histoplasmosis (POHS)

Start Date01 Jul 2026

Sponsor / Collaborator

Cincinnati Eye Institute

[+1]

100 Clinical Results associated with Faricimab

100 Translational Medicine associated with Faricimab

100 Patents (Medical) associated with Faricimab

603

Literatures (Medical) associated with Faricimab

01 Sep 2026·Ophthalmology and Therapy

Real-World Outcomes of Faricimab for Polypoidal Choroidal Vasculopathy in a Multi-ethnic Cohort: A 12-Month Retrospective Study

Article

Author: Riotto, Eleonora ; Spooner, Kimberly ; Trivizki, Omer ; Nicholson, Luke ; Faes, Livia ; Fasolo, Sandro ; Fu, Dun Jack ; Sivaprasad, Sobha

INTRODUCTION:

This study aimed to evaluate 12-month real-world outcomes of faricimab for polypoidal choroidal vasculopathy (PCV) in a multi-ethnic cohort.

METHODS:

This was a single-center retrospective cohort study of consecutive eyes with PCV diagnosed in routine care, treated with intravitreal faricimab, and with complete baseline and 12-month follow-up. One eye per patient was analyzed. Outcomes were reported for treatment-naïve and treatment-experienced eyes switched for persistent activity or limited durability. Primary endpoints were change in visual acuity (VA) and central subfield thickness (CST) at 12 months. Ethnicity-stratified outcomes were assessed secondarily.

RESULTS:

The cohort comprised 159 eyes (40 treatment-naïve, 119 treatment-experienced). In treatment-naïve eyes, mean VA improved from 61 (standard deviation [SD] 14) letters at baseline by + 6.8 letters (SD 16; P < 0.01) at 12 months, with CST reduction of - 54 µm (SD 100; P < 0.01) and mean 9.6 (SD 4.2) injections. In treatment-experienced eyes, paired VA change at 12 months was minimal (+ 0.27 letters, SD 12; P > 0.05), while CST decreased significantly by - 40 µm (SD 110; P < 0.01). Eyes received a mean of 8.2 (SD 4.2) faricimab injections over 12 months. Exploratory ethnicity-stratified analyses demonstrated baseline heterogeneity across groups, with broadly favorable anatomical and functional outcomes observed across the multi-ethnic cohort, but subgroup sizes precluded comparative efficacy assessment.

CONCLUSIONS:

In routine care, faricimab was associated with clinically meaningful visual improvement in treatment-naïve PCV and anatomical improvement in both treatment-naïve and -experienced eyes. Prospective studies with adequate ethnic representation are needed to validate these findings.

01 Sep 2026·RETINA-THE JOURNAL OF RETINAL AND VITREOUS DISEASES

ENDOPHTHALMITIS ASSOCIATED WITH INTRAVITREAL INJECTION

Article

Author: Yannuzzi, Nicolas A ; Snow, Zachary ; Rosenfeld, Philip J ; Townsend, Justin H ; Flynn, Harry W ; Rohowetz, Landon J ; Smiddy, William E

Purpose::

To report the rates, culture results, and visual acuity outcomes of endophthalmitis after intravitreal injection.

Methods::

Retrospective, consecutive case series of all patients who underwent intravitreal injection at University of Miami—Bascom Palmer Eye Institute between January 1, 2021, and December 31, 2025.

Results::

Endophthalmitis occurred following intravitreal injection in 3/28,358 (0.011%) eyes in 2021, 3/24,918 (0.012%) in 2022, 3/24,840 (0.012%) in 2023, 1/28,831 (0.003%) in 2024, and 0/31,269 in 2025 (0%). The use of ranibizumab decreased with time in the current study while faricimab usage increased. There was a slight increase in aflibercept usage after the approval of high dose 8 mg aflibercept in 2023. Complement inhibitors pegcetacoplan and avacincaptad pegol, approved in 2023 for geographic atrophy, were administered in 1,894 and 423 eyes, respectively, in 2024, and 1,083 and 578 eyes, respectively, in 2025; no cases of endophthalmitis were associated with either agent. Vitreous cultures demonstrated growth of Streptococcus mitis/oralis in 1/10 (10%), Staphylococcus aureus in 1/10 (10%), Granulicatella adiacens in 1/10 (10%), Staphylococcus epidermis in 1/10 (10%), Abiotrophia defectiva in 1/10 (10%), and were negative in 5/10 (50%). The cumulative incidence of endophthalmitis over the 5-year time period was 0.0072% (10/138,216) and was similar to rates reported between 2005 and 2020 at the same institution (P = 0.18). There were no differences in the rates of endophthalmitis between various medications (P = 0.32). After treatment, mean best-corrected visual acuity at last follow-up examination was 1.42 logMAR (20/526; range: 20/20 to no light perception).

Conclusion::

Endophthalmitis is a rare complication of intravitreal injection. In this study, the incidence of endophthalmitis was similar to previously reported rates and did not differ between agents.

01 Aug 2026·ACTA OPHTHALMOLOGICA

Beyond drug price: A comparison of overall costs of anti‐vascular endothelial growth factor therapy alternatives for neovascular age‐related macular degeneration in Norway

Article

Author: Løkken, Jacopo F. T. ; Moe, Morten Carstens ; Jørstad, Øystein Kalsnes ; Sæther, Erik Magnus

Abstract:

Purpose:

Norwegian guidelines designate off‐label Avastin as the first‐line intravitreal therapy for neovascular age‐related macular degeneration ( nAMD ) because of its well‐documented clinical efficacy and low price. However, this overlooks non‐drug costs, which increase with injection frequency. We evaluated whether newer, longer‐acting agents offer greater long‐term cost‐efficiency by reducing total costs despite higher drug prices in a Norwegian setting.

Methods:

We developed a 2‐year cost‐minimization model that included pharmaceutical, consultation and administrative and patient‐related costs in Norway; the pharmaceutical cost component incorporated the routine practice of splitting vials into prefilled syringes in hospital pharmacies. The model compared four nAMD monotherapies, Avastin, Eylea 2 mg, Eylea 8 mg and Vabysmo, as well as the common practice of switching treatment‐resistant patients from Avastin to Eylea 2 mg. We derived injection frequencies from clinical trials (for monotherapies) or observational data (for switching) and conducted one‐way sensitivity analyses to identify key cost drivers.

Results:

Over 2 years, the switching regimen had the highest per‐patient cost (146 722 NOK), followed by Eylea 2 mg (100 481 NOK), Vabysmo (93 207 NOK), Avastin (86 262 NOK) and Eylea 8 mg (68 738 NOK). Avastin had the lowest drug cost, but its high injection frequency increased non‐drug costs. Sensitivity analyses showed that injection frequency strongly influenced total costs for high‐priced drugs, while patient time had a substantial impact for Avastin.

Conclusion:

In our model, longer‐acting agents reduced injection frequency and decreased overall treatment costs. These findings suggest that adopting longer‐acting monotherapy could improve cost‐efficiency in long‐term nAMD management in Norway.

358

News (Medical) associated with Faricimab

08 Sep 2026

·www.globenewswire.com

A Micro-Cap Biotech Just Cleared a Milestone Most Never Reach

AUSTIN, Texas, Sept. 08, 2026 (GLOBE NEWSWIRE) -- BioMedWire Editorial Coverage: Multiple sclerosis (“MS”) drugs on the market today can slow the disease down, but none of them stop it, and none of them give patients back what they have already lost. Nearly one million people in the United States, and close to 2.9 million worldwide, live with that reality, watching a disease that can gradually erode mobility, vision, and basic bodily control. That gap has just gotten a serious new challenger. Quantum BioPharma Ltd. (NASDAQ: QNTM) (profile) has received FDA clearance to begin a phase 2 trial of Lucid-MS, a patented, first-in-class drug candidate aimed not at calming the immune system but at protecting and potentially repairing the myelin sheath itself. The clearance sets the stage for what would be the first time in history that a drug candidate built on this specific mechanism is tested in people living with the MS disease, a milestone significant enough that it has already drawn a fresh buy rating from Wall Street analysts. This momentum places Quantum BioPharma solidly in a group of leading companies focused on the treatment of serious diseases and areas of significant unmet medical need across vaccines, ophthalmology and neurological disease, including Sanofi (NASDAQ: SNY), Roche Holding AG (OTCQX: RHHBY), Biogen Inc. (NASDAQ: BIIB) and Clene Inc. (NASDAQ: CLNN). Research indicates that MS affects an estimated one million people in the United States and approximately 2.9 million people worldwide. The FDA's clearance of Quantum BioPharma's Investigational New Drug (“IND”) application marks a genuinely rare moment in MS research.In addition to the upcoming phase 2 drug trial, Quantum BioPharma has spent more than a year building a parallel research partnership with scientists at Massachusetts General Hospital (“MGH”) and Harvard Medical School. Lucid-MS, also known by its research designation Lucid-21-302, is built around a different theory of how to target MS progression. Clinical milestones matter to patients, but they also move markets, and Quantum BioPharma has recently drawn fresh attention from Wall Street analysts. Click here to view the custom infographic of the Quantum BioPharma editorial. A Disease That Takes Away Control Research indicates that MS affects an estimated one million people in the United States and approximately 2.9 million people worldwide. The disease occurs when a person's own immune system attacks myelin, the protective coating around nerve fibers that allows the brain to communicate with the rest of the body. Most people are diagnosed in their twenties or thirties, and women are affected roughly twice as often as men. Living with MS often means facing an unpredictable erosion of physical ability. Symptoms include fatigue, vision loss, numbness, and problems with balance and coordination. Over time many patients gradually lose fine motor control, mobility, and even bladder and bowel function. In addition, many people with MS end up managing a complicated mix of medications just to control symptoms alongside their core treatment, adding another daily burden on top of the disease itself. Nearly every currently approved MS therapy works by suppressing or modulating the immune system rather than directly protecting nerve tissue. Interferons, glatiramer acetate and newer monoclonal antibodies can reduce the frequency of relapses, and research confirms these drugs help many relapsing patients. But that same research shows the approach has real limits, since roughly one-half of patients on injectable immunomodulatory therapies stop taking them within the first year, and progressive forms of the disease remain especially hard to treat. Even large, well-funded competitors are still searching for something better. Several major pharmaceutical companies have advanced new MS candidates through late-stage trials in recent years only to see mixed or disappointing results, including recent failures in the broader field of myelin repair. That track record underscores how difficult it remains to develop a therapy that changes the disease's underlying course rather than just its symptoms. For patients, that means the wait for something that restores lost function, rather than merely slowing its loss, continues. A Historic First Human MS Test of a New Approach The FDA's clearance of Quantum BioPharma's Investigational New Drug (“IND”) application marks a genuinely rare moment in MS research. According to the company, the IND submission ran approximately 15,000 pages and includes a comprehensive package of pharmacology, toxicology and manufacturing data. With that clearance now secured, Quantum BioPharma can move directly into a randomized, double-blind, placebo-controlled phase 2 trial testing Lucid-MS in people suffering with MS. What makes this trial historic is the mechanism being tested on human patients with MS for the first time. Lucid-MS is a novel, first-in-class, non-covalent inhibitor of an enzyme called peptidyl arginine deiminase 2, or PAD2, that works by targeting demyelination rather than by suppressing the immune system. No FDA-approved MS therapy currently on the market has demonstrated the ability to prevent or reverse demyelination, and the broader field of remyelinating drug candidates has faced repeated setbacks. Quantum BioPharma's own CEO called the clearance a defining moment for the company. “FDA clearance to proceed with our Lucid-MS phase 2 trial is a transformative moment for Quantum and the result of years of dedicated scientific research,” stated Zeeshan Saeed, in the SEC filing. That filing also frames the trial within a global MS therapeutics market anticipated to reach approximately $38.62 billion by 2030. If Lucid-MS demonstrates in human patients what it has shown in preclinical models, the implications extend well beyond one company's pipeline. It would mark the first time a drug candidate targeting demyelination directly, rather than the immune system broadly, has shown in controlled human testing that it might help patients regain lost bodily control. That would represent a meaningfully different category of MS treatment than anything currently available to patients today. A Groundbreaking MS Imaging Collaboration In addition to the upcoming phase 2 drug trial, Quantum BioPharma has spent more than a year building a parallel research partnership with scientists at Massachusetts General Hospital (“MGH”) and Harvard Medical School. The focus of the research is solving a different but related problem: how to actually see demyelination happening in a living patient's brain. The collaboration centers on a novel PET imaging tracer called [¹⁸F]3F4AP. The tracer was developed by Dr. Pedro Brugarolas, an investigator in the Department of Radiology at MGH and assistant professor at Harvard Medical School, with Dr. Eric Klawiter, director of the Multiple Sclerosis and Neuromyelitis Optica Unit at MGH and associate professor of Neurology at Harvard Medical School, serving as co-investigator. In June 2025, the first person with MS was scanned using a newly installed combined PET-MR scanner at MGH, allowing researchers to capture PET and MRI data simultaneously with improved precision.By August 2025, the collaboration had already produced peer-reviewed results. Findings published in the European Journal of Nuclear Medicine and Molecular Imaging and funded by the National Institutes of Health showed that [18F]3F4AP had excellent properties for imaging the human brain and could detect differences across lesions that were not visible on conventional MRI. The study reached a key midpoint milestone in May 2026, with Brugarolas noting that the ability to directly quantify demyelinated lesions with intact axons represents an important unmet need in MS research. If fully validated, this imaging approach could eventually give researchers a far more direct and quantitative way to measure myelin loss and repair than MRI alone currently allows. That matters well beyond Quantum BioPharma's own research and development, since a reliable biomarker for demyelination could help evaluate any future therapy aimed at protecting or restoring myelin, not just Lucid-MS. For now, the imaging study and the phase 2 drug trial run on separate, parallel tracks, with Quantum BioPharma also working with a global contract research organization with CNS and MS trial experience, to support the drug trial's site-selection and start-up activities. The Science Behind Lucid-MS Lucid-MS, also known by its research designation Lucid-21-302, is built around a different theory of how to target MS progression. Rather than treating the immune system as the primary target, the compound is designed to act on PAD2, an enzyme expressed in the central nervous system that catalyzes a chemical process called citrullination of myelin proteins. That citrullination process is believed to contribute directly to the breakdown of myelin, making PAD2 inhibition a plausible way to interrupt disease progression at its source. The compound is a patented new chemical entity that has been studied for more than 11 years, with underlying research published in peer-reviewed journals including the “Journal of Medicinal Chemistry” and the “Proceedings of the National Academy of Sciences.” In preclinical animal models, the company reports that Lucid-MS accelerated functional recovery, preserved myelin and reduced axonal degradation, all without suppressing the immune system, distinguishing its proposed mechanism from nearly every currently marketed MS drug. That non-immunomodulatory profile is central to the company's scientific pitch. Because Lucid-MS is not designed to broadly dampen immune activity, the goal is to avoid the infection risk and other systemic side effects that can accompany immunosuppressive MS therapies, while directly addressing the demyelination process believed to drive long-term disability. The compound is also designed for potential oral administration with a comparatively simple dosing regimen, which could offer a meaningful convenience advantage over injectable or infused competitors if it succeeds in later-stage trials. Before reaching this point, Lucid-MS completed phase 1 clinical trials in healthy human volunteers, with the company reporting a favorable safety profile and good tolerability in that earlier testing. Dr. Andrzej Chruscinski, VP of Scientific and Clinical Affairs at Quantum, has said the IND submission reflects years of dedicated scientific research characterizing the compound's safety profile. With the FDA clearance now secured, the upcoming phase 2 trial will be the first opportunity to see whether that mechanism, built on more than a decade of laboratory work, actually helps people with progressive MS regain lost function. Wall Street Takes Notice Clinical milestones matter to patients, but they also move markets, and Quantum BioPharma has recently drawn fresh attention from Wall Street analysts. Rodman & Renshaw just initiated coverage of the company with a Buy rating and an $8 price target. The firm's report describes Lucid-MS as a potentially first-in-class, non-immunomodulatory small molecule aimed at addressing neurodegeneration and disability progression in progressive MS, an area where therapeutic options remain limited. Rodman & Renshaw’s $8 price target reflects its valuation of Quantum BioPharma's overall development pipeline, anchored by the newly cleared phase 2 program. This initiation follows earlier unpaid coverage from Kingswood Capital Partners, which set a $45 price target in September 2025 based on a discounted cash flow model assuming successful phase 2 and phase 3 trials and a 2029 commercial launch. New analyst coverage matters for a clinical-stage biopharmaceutical company because it signals that outside experts, with no obligation to be optimistic, see enough evidence in the data to justify a formal recommendation. For a small-cap company preparing to enter a pivotal trial, that kind of third-party validation can help build the visibility and credibility needed to support the stock through a long and expensive testing process. It also gives investors a data point beyond the company's own announcements when weighing the risk and potential reward of the phase 2 program. Collectively, the FDA clearance and phase 2 studies, the Harvard-affiliated imaging collaboration and the new analyst coverage paint a picture of a company methodically building the pieces needed to test a genuinely different approach to multiple sclerosis. Quantum BioPharma is still a clinical-stage company, and like any drug candidate entering human trials, there are no guarantees of success. But few companies ever reach this point: Lucid-MS is now cleared for its first real test in people living with progressive MS, giving the company a genuine chance to show that protecting the myelin sheath directly can succeed where decades of immune-focused treatments have fallen short. Biotech Leaders Advance Next-Generation Therapies Innovation across the biopharmaceutical sector continues to accelerate as companies pursue new approaches to serious diseases and areas of significant unmet medical need. Recent developments spanning infectious-disease prevention, ophthalmology and neurological disease highlight the breadth of work underway. Sanofi (NASDAQ: SNY) announced that the European Commission (“EC”) has approved an extension of the indication for MenQuadfi (Meningococcal Group A, C, W and Y conjugate vaccine) to include infants from six weeks of age to help protect against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. MenQuadfi was previously approved in the EU for use in individuals aged 12 months and older. The expanded indication follows the positive opinion adopted by the Committee for Medicinal Products for Human Use on June 25, 2026. Roche Holding AG (OTCQX: RHHBY) released new two-year data from the phase IIIb/IV SALWEEN study of Vabysmo(R) (faricimab), presented at the 19th Asia-Pacific Vitreo-retina Society (“APVRS”) Congress in Australia. The results showed significant improvements in vision and retinal health in patients with polypoidal choroidal vasculopathy (“PCV”), a severe subtype of neovascular age-related macular degeneration (“nAMD”), the leading cause of vision loss in people over the age of 60. Biogen Inc. (NASDAQ: BIIB) reported that the National Medical Products Administration (“NMPA”) of China has approved the subcutaneous formulation, the anti-amyloid beta (Aβ) protofibril antibody LEQEMBI(R), as an initiation treatment for mild cognitive impairment (“MCI”) due to Alzheimer’s disease (“AD”) or mild AD dementia, collectively referred to as early AD. The application was accepted by the NMPA in January 2026 and was subsequently granted Priority Review designation. Clene Inc. (NASDAQ: CLNN) shared results from new analyses examining clinical outcomes among CNM-Au8(R)-treated patients whose neurofilament light chain (“NfL”) biomarker levels declined or stabilized. These findings will be included in Clene’s planned New Drug Application (“NDA”) seeking accelerated approval and are intended to address the questions raised by the U.S. Food and Drug Administration (“FDA”) during a March 2026 Type C meeting. At that meeting, the FDA acknowledged that NfL, a recognized blood marker of nerve-cell injury, has established prognostic value in amyotrophic lateral sclerosis (“ALS”) and could potentially serve as a reasonably likely surrogate endpoint to support accelerated approval. As established and emerging biopharmaceutical companies continue to advance new medicines and treatment strategies, developments across these diverse therapeutic areas underscore both the breadth of medical need and the opportunity for continued innovation. From disease prevention and vision preservation to new approaches for neurodegenerative disorders, these advances illustrate the range of scientific and regulatory progress taking place across the sector. For more information, visit Quantum BioPharma Ltd.About BioMedWire BioMedWire (“BMW”) is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. It is one of 75+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, BMW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, BMW brings its clients unparalleled recognition and brand awareness.BMW is where breaking news, insightful content and actionable information converge.To receive SMS alerts from BioMedWire, “Biotech” to 888-902-4192 (U.S. Mobile Phones Only)For more information, please visit https://www.BioMedWire.comDISCLAIMER: BioMedWire (BMW) is the source of the Article and content set forth above. References to any issuer other than the profiled issuer are intended solely to identify industry participants and do not constitute an endorsement of any issuer and do not constitute a comparison to the profiled issuer. The commentary, views and opinions expressed in this release by BMW are solely those of BMW. Readers of this Article and content agree that they cannot and will not seek to hold liable BMW for any investment decisions by their readers or subscribers. BMW is a news dissemination and financial marketing solutions provider and are NOT registered broker-dealers/analysts/investment advisers, hold no investment licenses and may NOT sell, offer to sell or offer to buy any security.The Article and content related to the profiled company represent the personal and subjective views of the Author and are subject to change at any time without notice. The information provided in the Article and the content has been obtained from sources which the Author believes to be reliable. However, the Author has not independently verified or otherwise investigated all such information. None of the Author, BMW, or any of their respective affiliates, guarantee the accuracy or completeness of any such information. This Article and content are not, and should not be regarded as investment advice or as a recommendation regarding any particular security or course of action; readers are strongly urged to speak with their own investment advisor and review all of the profiled issuer’s filings made with the Securities and Exchange Commission before making any investment decisions and should understand the risks associated with an investment in the profiled issuer’s securities, including, but not limited to, the complete loss of your investment.BMW HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “may”, “future”, “plan” or “planned”, “will” or “should”, “expected,” “anticipates”, “draft”, “eventually” or “projected”. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company’s annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and BMW undertakes no obligation to update such statements.Please see full terms of use and disclaimers on the BioMedWire website applicable to all content provided by BMW, wherever published or re-published: https://www.BioMedWire.com/DisclaimerBioMedWireAustin, Texaswww.BioMedWire.com512.354.7000 OfficeEditor@BioMedWire.comBioMedWire is powered by IBN

Phase 2Drug ApprovalPhase 1Clinical Result

01 Sep 2026

·retinalphysician.com

Vabysmo Maintains Vision Gains in PCV at 2 Years

Roche announced new 2-year data from the phase 3b/4 SALWEEN study of Vabysmo (faricimab), presented at the 19th Asia-Pacific Vitreo-retina Society Congress in Australia. The results showed significant improvements in vision and retinal health in patients with polypoidal choroidal vasculopathy (PCV), a severe subtype of neovascular age-related macular degeneration (nAMD), the company said in a press release. The study showed that patients experienced a gain of 7.3 letters in best-corrected visual acuity (BCVA) and a reduction of 127 µm in central subfield thickness from baseline averaged over weeks 100 to 108. At year 2, 74% of patients had no retinal fluid. Vabysmo also had a clinically meaningful impact on the abnormal, polyp-like blood vessels characteristic of PCV, with complete regression (62%) and inactivation (86%) of polypoidal lesions in the majority of eyes. At the end of the first year, 51% of patients were assigned to extended 20-week dosing, which increased to 61% by the end of year 2. Vabysmo was well tolerated, with a safety profile in PCV that was consistent with its known safety profile in nAMD, the company said in the press release. SALWEEN was a phase 3b/4 multicenter, open-label, single-arm study of Vabysmo for the treatment of Asian people with PCV. It enrolled 135 patients aged 50 years and over from 38 sites across 9 markets in Asia, including China, Hong Kong SAR, India, Japan, Malaysia, Singapore, South Korea, Taiwan, and Thailand. Patients received 4 loading doses of Vabysmo 6 mg over 12 weeks. After that, their treatment schedule was adjusted based on their progress, with doses given every 8, 12, or 16 weeks. From weeks 44 to 104, patients followed a personalized treatment plan with treatment intervals extended up to 20 weeks. The primary endpoint was the change from baseline in BCVA averaged over weeks 40 to 48. RP

Clinical Result

28 Aug 2026

·www.biospace.com

Roche’s Vabysmo demonstrates sustained two-year results in a difficult-to-treat form of neovascular age-related macular degeneration (nAMD)

The SALWEEN study showed significant improvements in vision and retinal health 1 More than 60% of Asian patients with polypoidal choroidal vasculopathy (PCV), an aggressive subtype of nAMD, treated with Vabysmo showed no signs of polypoidal lesions 1,2 By the end of year two, more than 60% of patients were on an extended 20-week treatment interval, reducing treatment burden 1 Vabysmo was well tolerated with a consistent long-term safety profile 1 Basel, 28 August 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today new two-year data from the Phase IIIb/IV SALWEEN study of Vabysmo ® (faricimab), presented at the 19 th Asia-Pacific Vitreo-retina Society (APVRS) Congress in Australia. 1 The results showed significant improvements in vision and retinal health in patients with polypoidal choroidal vasculopathy (PCV), a severe sub-type of neovascular age-related macular degeneration (nAMD), the leading cause of vision loss in people over the age of 60. 1-3 “The two-year SALWEEN results demonstrate the sustained efficacy and durability of Vabysmo in people living with PCV, a difficult-to-treat subtype of nAMD that is common in Asia,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Since its initial approval, Vabysmo continues to demonstrate strong efficacy, durability and a favourable safety pro treating a range of high-burden eye diseases.” "PCV is an aggressive subtype of nAMD that accounts for up to 60% of cases in Asian populations — a burden that will only grow as the population ages,” said Professor Gemmy Cheung, MBBS, FRCOphth, MD, PhD, Duke-NUS Medical School, National University of Singapore. “These two-year results show that dual Ang-2/VEGF-A inhibition can change the trajectory of this vision-threatening disease. Achieving polypoidal lesion inactivation in nearly nine out of 10 patients, while allowing most to maintain a 20-week dosing interval, means Vabysmo can provide disease control while also drastically reducing the treatment burden." The study showed that patients experienced a gain of 7.3 letters in best-corrected visual acuity (BCVA) and a reduction of 127 µm in central subfield thickness (CST) from baseline averaged over weeks 100–108. At year two, 74% of patients had no retinal fluid. Vabysmo also had a clinically meaningful impact on the abnormal, polyp-like blood vessels characteristic of PCV, with complete regression (62%) and inactivation (86%) of polypoidal lesions in the majority of eyes. At the end of the first year, 51% of patients were assigned to extended 20-week dosing, which increased to 61% by the end of year two. Vabysmo was well tolerated, with a safety pro PCV that was consistent with its known safety pro nAMD. 1 About neovascular age-related macular degeneration Age-related macular degeneration (AMD) is a condition that affects the part of the eye that provides sharp, central vision needed for activities like reading. nAMD is an advanced form of the disease that can cause rapid and severe vision loss if left untreated. 4-6 It develops when new and abnormal blood vessels grow uncontrolled under the macula, causing swelling, bleeding and/or fibrosis. 6 Worldwide, around 20 million people are living with nAMD – the leading cause of vision loss in people over the age of 60 – and the condition will affect even more people around the world as the global population ages. 3,4,7 About polypoidal choroidal vasculopathy Polypoidal choroidal vasculopathy (PCV) is a subtype of nAMD that is more prevalent in people of Asian descent, accounting for up to 60% of nAMD cases in this population and up to 20% in people of European descent. 2 PCV is characterised by abnormal blood vessels in the choroid, a thin layer of tissue between the sclera (the whites of the eyes) and the retina. These abnormal vessels can leak fluid or blood, leading to retinal damage and vision loss. 2,8,9 People with PCV often experience blurred vision or a blind spot in or near the centre of their vision in one or both eyes. 9,10 Early diagnosis and treatment are important to help restore vision and prevent further vision loss. 8,11 About SALWEEN SALWEEN was a Phase IIIb/IV multicentre, open-label, single-arm study of Vabysmo for the treatment of Asian people with PCV. It enrolled 135 patients aged 50 years and over from 38 sites across nine markets in Asia, including China, Hong Kong SAR, India, Japan, Malaysia, Singapore, South Korea, Taiwan and Thailand. Patients received four loading doses of Vabysmo 6 mg over 12 weeks. After that, their treatment schedule was adjusted based on their progress, with doses given every eight, 12, or 16 weeks. From weeks 44 to 104, patients followed a personalised treatment plan with treatment intervals extended up to 20 weeks. The primary endpoint was the change from baseline in BCVA averaged over weeks 40-48. 1 About Vabysmo® (faricimab) Vabysmo is the first bispecific antibody approved for the eye. 12-14 It targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood vessels. 14,15 Vabysmo is approved in more than 100 countries around the world, including the United States (US), Japan, the United Kingdom and the European Union (EU) for people with neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema, and in more than 60 countries, including the US, EU and Japan, for people with macular edema following retinal vein occlusion (RVO). 12,13,16-19 Review by other health authorities is ongoing. About Roche in Ophthalmology Roche is focused on saving people’s eyesight from the leading causes of vision loss through pioneering therapies. Through our innovation in the scientific discovery of new potential drug targets, personalised healthcare, molecular engineering, biomarkers and continuous drug delivery, we strive to design the right therapies for the right patients. We have the broadest retina pipeline in ophthalmology, which is led by science and informed by insights from people with eye diseases. Our pipeline includes innovative treatments across different modalities, such as antibodies, and gene and cell therapies targeting multiple vision-threatening conditions, including retinal vascular and diabetic eye diseases, geographic atrophy, and autoimmune conditions, such as thyroid eye disease and uveitic macular edema. About Roche Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them. Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market. For more information, please visit . All trademarks used or mentioned in this release are protected by law. References [1] Lai TYY, et al. Faricimab for Polypoidal Choroidal Vasculopathy (PCV): Two-Year Results From the SALWEEN Trial. Presented at: 19 th Asia-Pacific Vitreo-retina Society (APVRS) Congress; August 28, 2026; Gold Coast, Australia. [2] Cheung CMG. Macular neovascularization and polypoidal choroidal vasculopathy: phenotypic variations, pathogenic mechanisms and implications in management. Eye (Lond). 2024;38(4):659-667. doi:10.1038/s41433-023-02764-w. [3] Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014;2(2):e106-e116. doi:10.1016/S2214-109X(13)70145-1. [4] Macular Degeneration Facts & Figures. BrightFocus Foundation. [Internet; cited August 2026]. Available from: . [5] Pennington KL, DeAngelis MM. Epidemiology of age-related macular degeneration (AMD): associations with cardiovascular disease phenotypes and lipid factors. Eye Vis (Lond). 2016;3:34. doi:10.1186/s40662-016-0063-5. [6] Little K, Ma JH, Yang N, Chen M, Xu H. Myofibroblasts in macular fibrosis secondary to neovascular age-related macular degeneration - the potential sources and molecular cues for their recruitment and activation. EBioMedicine. 2018;38:283-291. doi:10.1016/j.ebiom.2018.11.029. [7] Connolly E, Rhatigan M, O'Halloran AM, et al. Prevalence of age-related macular degeneration associated genetic risk factors and 4-year progression data in the Irish population. Br J Ophthalmol. 2018;102(12):1691-1695. doi:10.1136/bjophthalmol-2017-311673. [8] Cheung CMG, Lai TYY, Ruamviboonsuk P, et al. Polypoidal Choroidal Vasculopathy: Definition, Pathogenesis, Diagnosis, and Management. Ophthalmolog y . 2018;125(5):708-724. doi:10.1016/j.ophtha.2017.11.019. [9] Polypoidal Choroidal Vasculopathy. The Foundation of the American Society of Retina Specialists. [Internet; cited August 2026]. Available from: . [10] Polypoidal Choroidal Vasculopathy. Scott E. Pautler, M.D. Tampa. [Internet; cited August 2026]. Available from: . [11] Chawla H, Blair K, Vohra V. Polypoidal Choroidal Vasculopathy. In: Stat Pearls. Stat Pearls Publishing; March 16, 2023. [Internet; cited August 2026]. Available from: . [12] United States (US) Food and Drug Administration (FDA). Highlights of Prescribing Information, Vabysmo. April 2026. [Internet; cited August 2026]. Available from: . [13] Medicines and Healthcare products Regulatory Agency approves faricimab through international work-sharing initiative. May 17, 2022. [Internet; cited August 2026]. Available from: . [14] Heier JS, Khanani AM, Quezada Ruiz C, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022;399(10326):729-740. doi:10.1016/S0140-6736(22)00010-1. [15] Wykoff CC, Abreu F, Adamis AP, et al. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. Lancet. 2022;399(10326):741-755. doi:10.1016/S0140-6736(22)00018-6. [16] European Medicines Agency. Summary of Product Characteristics, Vabysmo. August 2026. [Internet; cited August 2026]. Available from: . [17] Chugai obtains regulatory approval for Vabysmo, the only bispecific antibody in the ophthalmology field, for additional indication of macular edema associated with RVO. March 26, 2024. [Internet; cited August 2026]. Available from: . [18] Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, for nAMD and DME. March 28, 2022. [Internet; cited August 2026]. Available from: . [19] Roche data on file. Roche Global Media Relations Phone: +41 61 688 8888 / e-mail: media.relations@roche.com Tristan Schmitz Phone: +41 79 529 70 35 Lorena Corfas Phone: +41 79 568 24 95 Simon Goldsborough Phone: +44 797 32 72 915 Karsten Kleine Phone: +41 79 461 86 83 Kirti Pandey Phone: +41 79 398 38 53 Yvette Petillon Phone: +41 79 961 92 50 Irène Stephan Phone: +41 79 377 83 75 Albert Thottiyil Phone: +41 79 775 66 12 Attachment Media Release SALWEEN APVRS English

Clinical ResultDrug ApprovalPhase 3

100 Deals associated with Faricimab

External Link

KEGG	Wiki	ATC	Drug Bank
D11516	Faricimab	-	DB15303

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Angioid Streaks	Japan	Chugai Pharmaceutical Co., Ltd.	19 May 2025
Retinal vein occlusion-related macular edema	Australia	Roche Products Pty Ltd.	08 Aug 2022
Age Related Macular Degeneration	Japan	Chugai Pharmaceutical Co., Ltd.	28 Mar 2022
Choroidal Neovascularization	Japan	Chugai Pharmaceutical Co., Ltd.	28 Mar 2022
Dystrophy, Macular	Japan	Chugai Pharmaceutical Co., Ltd.	28 Mar 2022
Diabetic macular oedema	United States	Genentech, Inc.	28 Jan 2022
Wet age-related macular degeneration	United States	Genentech, Inc.	28 Jan 2022

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Retinal Vein Occlusion	NDA/BLA	United States	Roche Holding AG	09 May 2023
Proliferative retinopathy with diabetes mellitus	Phase 3	United States	Genentech, Inc.	04 Aug 2025
Myopic choroidal neovascularization	Phase 3	China	F. Hoffmann-La Roche Ltd.	28 Feb 2024
Myopic choroidal neovascularization	Phase 3	China	Roche China Holding Ltd.	28 Feb 2024
Myopic choroidal neovascularization	Phase 3	Australia	Roche China Holding Ltd.	28 Feb 2024
Myopic choroidal neovascularization	Phase 3	Australia	F. Hoffmann-La Roche Ltd.	28 Feb 2024
Myopic choroidal neovascularization	Phase 3	France	Roche China Holding Ltd.	28 Feb 2024
Myopic choroidal neovascularization	Phase 3	France	F. Hoffmann-La Roche Ltd.	28 Feb 2024
Myopic choroidal neovascularization	Phase 3	Germany	Roche China Holding Ltd.	28 Feb 2024
Myopic choroidal neovascularization	Phase 3	Germany	F. Hoffmann-La Roche Ltd.	28 Feb 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


FARWIDE-RVO (ARVO2026)	Not Applicable	Retinal Vein Occlusion	1,075	faricimab (Treatment-naïve (TN) BRVO eyes)	gdnkawbmnd(wjzuddibvp) = bgnkmfyrwk jofxjoanya (xrrylcmqvv, 61 - 77) View more	Positive	03 May 2026
				faricimab (Previously treated with anti-VEGF (PT) BRVO eyes)	gdnkawbmnd(wjzuddibvp) = gisbkbggrl jofxjoanya (xrrylcmqvv, 58 - 77) View more
ARVO2026	Not Applicable	-	159	Aflibercept 8 mg	-	Positive	03 May 2026
				Faricimab	yvzeijlmtr(ftzlwqadei) = rzympjqsxa jwgnlmgjjd (aaexrrwlki ) View more
ARVO2026	Not Applicable	Wet age-related macular degeneration	912	Faricimab	fdfmrhliuq(bgmtqduabj) = ellybxpqav ksvbcyfcjt (cikgfnmwda ) View more	Positive	03 May 2026
				Aflibercept	fdfmrhliuq(bgmtqduabj) = gvopqzjotn ksvbcyfcjt (cikgfnmwda ) View more
NCT04777201 (AVONELLE-X, ARVO2026)	Phase 3	-	1,029	Faricimab 6 mg + Faricimab 6 mgept	xouhsuyzob(vixmsmevej) = Faricimab was well tolerated through 2 years of AVONELLE-X. vpcbcljezo (ystefndcug ) View more	Positive	03 May 2026
ARVO2026	Not Applicable	Wet age-related macular degeneration	146	Faricimab (neovascular AMD + treatment-naive)	cgpbocgpev(ftuvbjozmk) = iasulymbxz fmprojcmkm (uxtvhmfeuc ) View more	Positive	03 May 2026
				Aflibercept 2mg (neovascular AMD + treatment-naive)	wfbmmvmtdu(opeopdghki) = hqzrovufat ddqylxzlcd (ktvaycanmo ) View more
ARVO2026	Not Applicable	Diabetic macular oedema \| Retinal Vein Occlusion \| Wet age-related macular degeneration	4,200	Faricimab (patients with nAMD)	ukozsnxtaa(jhlaujpjwl) = pxnqodjvqg hcrgupjkwj (wnaqfmguzc, 1.16 - 2.03) View more	Positive	03 May 2026
				Faricimab (patients with DMO)	ukozsnxtaa(jhlaujpjwl) = yoyifdsxlf hcrgupjkwj (wnaqfmguzc, 1.12 - 2.28) View more
NCT03823287 (TENAYA, ARVO2026)	Phase 3	-	1,329	Faricimab 6 mg	msmhpungdu(ybfmgkwnol) = tisfdhcuxh qpnbqgrnhk (moafzpnfgp, -202.8 to -165.1) View more	Positive	03 May 2026
				Aflibercept 2 mg	msmhpungdu(ybfmgkwnol) = uzzsdanbyq qpnbqgrnhk (moafzpnfgp, -157.6 to -118.9) View more
FARI-LATAM (ARVO2026)	Not Applicable	Diabetic macular oedema	203	Faricimab (poor response to other medications)	vazgsjzolc(kllrqoitws) = zenzpfanti rklszsgjen (fzaphcohtn, 2.3)	Positive	03 May 2026
ARVO2026	Not Applicable	Endophthalmitis	199	Faricimab (IVF)	cacgpnyjao(xwuichfoft) = zcrhpfprvm kgnunaodfc (sdzckpqzix ) View more	Positive	03 May 2026
				Aflibercept (IVA-HD)	knoklnzazi(kxporpbsat) = dkfunvqurd hxvwfomqtc (ieamuoxlno )
ARVO2026	Not Applicable	Diabetic macular oedema \| Wet age-related macular degeneration	220	Faricimab (Neovascular Age-Related Macular Degeneration)	entvhrmaow(taklntgstv) = All reported adverse events occurred in nAMD patients and included submacular hemorrhage (2 eyes), RPE tear (1 eye) and increased intraocular pressure (1 eye). No intraocular inflammation was reported. btgxkxgbwo (telklpzfad ) View more	Positive	03 May 2026
				Faricimab (Diabetic Macular Edema)

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis