Ranibizumab (Genentech)

A real-world PMS study based on a large population demonstrates comparable safety pro SB11 (BYOOVIZ ® / AMELIVU ® ) to reference ranibizumab In treatment-naïve patients, SB11 provided functional and anatomical improvements, while BCVA and CST were well maintained in patients who were switched from other anti-VEGF treatments to SB11, adding clinical confidence in using SB11 INCHEON, Korea and NASHVILLE, Tenn., July 20, 2026 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, presented interim data from a post-marketing surveillance (PMS) study on SB11 (US brand name: BYOOVIZ ® , Korea brand name: AMELIVU ® ), a biosimilar referencing Lucentis 1 , at the 44 th Annual Meeting of the American Society of Retina Specialists (ASRS), held in Montréal, Canada, July 15–18, 2026. “The interim results from this large-scale post-marketing surveillance study reinforce the comparable safety pro SB11 to reference ranibizumab. Importantly, the study demonstrated clinically meaningful efficacy improvement in treatment-naïve patients while maintaining efficacy in those switched from other anti-VEGF therapies,” said Donghoon Shin, Executive Vice President and Head of Clinical Sciences Division, Samsung Bioepis. "At Samsung Bioepis, we are committed to generating robust real-world evidence that can support retinal specialists in making informed treatment decisions for their patients." "We believe this post-marketing surveillance data further strengthens the clinical foundation supporting BYOOVIZ, reinforcing the confidence retina specialists can have in this biosimilar option — both in treatment-naïve patients and those transitioning from other anti-VEGF therapies," said Mark L. Baum, Chief Executive Officer of Harrow. "We're grateful for our collaboration with Samsung Bioepis in generating this evidence, and we remain committed to giving physicians the data they need to prescribe with confidence." This open-label, prospective, multicenter, observational, Phase 4 PMS study, initiated in May 2022 and completed in May 2026, was designed to evaluate real-world safety and efficacy data for SB11 by evaluating a large patient population from a PMS study conducted in Republic of Korea. The interim report includes data from 298 patients (182 treatment-naïve, 116 switched) out of 305 patients who had been enrolled in the study as of the interim data cutoff. To reflect real-world practice, treatment interval was determined at the investigator’s discretion, and the study followed up with patients up to 24 weeks after the first dose. Efficacy was assessed by best-corrected visual acuity (BCVA) and central subfield thickness (CST), with subgroup analyses by treatment status (naïve/switched). Safety was evaluated by the incidence of adverse events. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); The mean (standard deviation; SD) BCVA improved by -0.10 (0.29) in the treatment-naïve patients and -0.03 (0.24) in switched patients (P= 0.0239). Mean (SD) CST improved by -95 (125) µm in the treatment-naïve patients and -53 (108) µm in switched patients (P= 0.0168). Across different indications, there was no statistically significant difference in BCVA (P=0.6312) and CST (P=0.1686) outcome. In contrast, disease duration was significantly associated with BCVA (P= 0.0003) and CST (P=0.001) outcomes, suggesting that earlier treatment may lead to a better visual prognosis. No new safety concerns were identified. Title: Efficacy and Safety of SB11 in Treatment-Naïve and Switched Patients with Retinal Diseases: Interim Results from a Post-Marketing Surveillance Study Authors: Hyun Seung Yang, Se Joon Woo, Christopher Seungkyu Lee, Hyung-Il Kim, Kyu-Seop Kim, Kwan Hyuk Cho, Kwang Soo Kim, Inkyung Oh, Mercy Yeeun Kim, Juntae Kim, Daniel Duck-Jin Hwang Presentation Type: paper on demand (Category: POD 1: AMD – Neovascular) About BYOOVIZ BYOOVIZ (ranibizumab-nuna) injection, for intravitreal use is a biosimilar to LUCENTIS (ranibizumab injection) INDICATIONS AND USAGE BYOOVIZ, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Myopic Choroidal Neovascularization (mCNV) IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Ocular or periocular infections Hypersensitivity WARNINGS AND PRECAUTIONS Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection Increases in intraocular pressure (IOP) have been noted both pre- and post intravitreal injection There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors ADVERSE REACTIONS The most common adverse reactions (reported more frequently in ranibizumab treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP Please see full Prescribing information About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit and follow us on LinkedIn and X . About Harrow Harrow, Inc. (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America, offering a comprehensive portfolio of products that address conditions affecting both the front and back of the eye, such as dry eye disease, wet (or neovascular) age-related macular degeneration, cataracts, refractive errors, glaucoma and a range of other ocular surface conditions and diseases of the retina. Harrow was founded with a commitment to deliver safe, effective, accessible, and affordable medications that enhance patient compliance and improve clinical outcomes. For more information about Harrow, please visit harrow.com and connect with us on LinkedIn . Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, risks related to: liquidity or results of operations; our ability to successfully implement our business plan, develop and commercialize our products, product candidates and proprietary formulations in a timely manner or at all, identify and acquire additional products, manage our pharmacy operations, service our debt, obtain financing necessary to operate our business, recruit and retain qualified personnel, manage any growth we may experience and successfully realize the benefits of our previous acquisitions and any other acquisitions and collaborative arrangements we may pursue; competition from pharmaceutical companies, outsourcing facilities and pharmacies; general economic and business conditions, including inflation and supply chain challenges; regulatory and legal risks and uncertainties related to our pharmacy operations and the pharmacy and pharmaceutical business in general, including the ongoing communications with the U.S. Food and Drug Administration relating to compliance and quality plans at our outsourcing facility in New Jersey; physician interest in and market acceptance of our current and any future formulations and compounding pharmacies generally. These and additional risks and uncertainties are more fully described in Harrow’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2025, and other filings with the SEC. Such documents may be read free of charge on the SEC's web site at sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. MEDIA CONTACT – Samsung Bioepis Anna Nayun Kim, nayun86.kim@samsung.com Yoon Kim, yoon1.kim@samsung.com MEDIA CONTACT – Harrow Mike Biega Vice President of Investor Relations and Communications mbiega@harrowinc.com 617-913-8890 1 Lucentis is a trademark of Genentech.

Positive proof-of-concept clinical data show substantial improvements in visual acuity in limbal stem cell deficiency ( LSCD) patients treated with CSB-001 Pivotal studies for CSB-001 in LSCD planned for 1H 2027 Series B funds Claris through pivotal development and supports pre-commercialization activities Stephen Brady appointed President and Chief Executive Officer, Brian Baum named Chief Commercial Officer, and Marc de Garidel appointed Chairman of the Board ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); JERSEY CITY, N.J., July 28, 2026 (GLOBE NEWSWIRE) -- Claris Biotherapeutics, Inc. , a late-stage biopharmaceutical company dedicated to advancing transformative therapies for sight-threatening conditions where limited or no treatment options exist, today announced multiple key milestones, including the close of a $118 million Series B financing and key executive and board appointments. These catalysts are designed to accelerate the company’s next phase of growth as it advances CSB-001 (oremepermin alfa ophthalmic solution) based on positive proof-of-concept data towards the planned initiation of pivotal studies in 1H 2027 in patients with limbal stem cell deficiency (LSCD), a blinding disease impacting the ocular surface, representing an area of high unmet need where no approved drug therapy exists. Financing Details The $118M Series B financing was co-led by new investors Samsara Biocapital and Catalio Capital Management, and joined by Adage Capital Management, Sofinnova Investments, Aisling Capital, and ADAR1 Capital Management, with continued support from all existing investors, Novo Holdings, Janus Henderson Investors, and Mass General Brigham Ventures. Proceeds from the fundraise will be used to complete Claris’ ongoing clinical trials in patients with LSCD, including a proof-of-concept study evaluating CSB-001 and a non-interventional natural history study. The financing will also fund the company through a planned pivotal program of CSB-001 in patients with LSCD, scheduled to start in 1H 2027, and enable pre-commercialization activities. CSB-001 targets the underlying pathophysiology of LSCD by promoting corneal epithelial regeneration while modulating inflammation and fibrosis. Clinical data generated to date have demonstrated substantial improvements in visual acuity. Claris expects to report its proof-of-concept results in LSCD during the second half of 2026. In connection with the financing, Stephen Brady, President and CEO of Claris, Mike Dybbs, Ph.D., Partner at Samsara Biocapital, Matthew Hobson, Ph.D., Principal at Catalio Capital Management, and Maha Radhakrishnan, M.D., Executive Partner at Sofinnova Investments, joined the board of directors. Claris Appointments Stephen Brady, President & CEO , has nearly 30 years of operational, transactional, and board experience spanning corporate strategy, M&A, business development, and finance across public and private life sciences companies. Prior to Claris, Mr. Brady was the Chairman of the Board and CEO of Tempest Therapeutics, and prior to this position, he was executive vice president of strategy and finance at Immune Design and played a key role in the company's IPO, financings, licensing deals, and eventual sale to Merck. Earlier in his career, he held progressively senior roles at several biopharmaceutical companies, including vice president of corporate development at Proteolix. In this position, Mr. Brady led Proteolix’s business development and strategic efforts that culminated in the company’s sale to Onyx Pharmaceuticals. Proteolix’s lead asset, Kyprolis ® (carfilzomib), subsequently became the cornerstone of Onyx and a principal driver of Amgen’s $10.4 billion acquisition of Onyx. Mr. Brady currently serves on the Board of Directors of Claris and the Biotechnology Innovation Organization (BIO). Brian Baum, CCO, brings to Claris more than 20 years of program and lifecycle management, commercial strategy, marketing, market access, commercial operations, and specialty product launch experience in biopharma. Prior to Claris, Mr. Baum served as Senior Vice President at Dompé Pharmaceuticals and led critical commercial initiatives that supported the successful U.S. launch and growth of Oxervate ® , a recombinant human nerve growth factor approved in 2018 for neurotrophic keratitis, a rare and serious eye disease with no prior FDA-approved therapies. As a senior commercial leader, Mr. Baum played a key role in driving Oxervate’s growth, with annual U.S. sales surpassing $1.1 billion in 2024. Prior to Dompé, Mr. Baum spent ten years at Genentech in a range of U.S. and global commercial leadership roles, including supporting the launch and commercialization of Lucentis ® across three major retinal indications: wAMD, RVO, and DME. Marc de Garidel, Chairman, is a recognized biotech entrepreneur and global pharmaceutical executive with a distinguished track record of building and scaling innovative healthcare companies, advancing breakthrough therapies, and creating substantial shareholder value through organic growth and strategic M&A across the biotechnology sector. Since May 2023, Mr. de Garidel has served as CEO of Abivax, leading the development of obefazimod for ulcerative colitis and driving exceptional corporate growth, from a $500 million to a $14 billion company in over three years. Prior to Abivax, he was CEO of CinCor Pharma from 2020 to 2023, where he successfully led the company through its acquisition by AstraZeneca. CinCor’s lead therapy was subsequently approved by the FDA as a first-in-class treatment for resistant hypertension. From 2018 to 2020, Mr. de Garidel served as CEO of Corvidia Therapeutics, overseeing its strategic growth and successful acquisition by Novo Nordisk. Earlier in his career, he served as CEO of Ipsen from 2010 to 2016, where he transformed the company into a leading global oncology player through the expansion of Somatuline and the landmark ex-U.S. licensing agreement for Cabometyx. Mr. de Garidel began his career at Eli Lilly and Company before spending 15 years at Amgen in senior international leadership roles. He has also served as Chairman of Ipsen since late 2010. “I’m thrilled to join Claris at such a pivotal moment in the company’s evolution,” said Mr. Brady, President and CEO of Claris. “The strong interest in CSB-001 reflects both its promise for patients and commercial potential. With the company financed through Phase 3 and the team in place to execute, we're ready to advance CSB-001 from a position of strength. The prospect of significantly improving vision with a convenient eye drop is a tremendous advance, and I'm energized by the opportunity to take on a blinding disease like LSCD.” Marc de Garidel, Chairman of Claris Bio, added, “Claris is entering a defining period in its growth. In addition to welcoming Steve and Brian to Claris’ leadership team, I’d like to thank our founding CEO, Clarke Atwell, for his years of diligence in building the team and advancing the science underlying CSB-001, which allows us to approach this watershed moment with confidence. We look forward to continuing our work to advance CSB-001 in patients with limbal stem cell deficiency and lead the company through its next phase as we approach commercialization.” About LSCD and CSB-001 Limbal stem cell deficiency (LSCD) is a disease of the eye in which specialized stem cells that continuously replenish and repair the corneal surface are damaged or destroyed, leading to severe vision loss or blindness. CSB-001 (oremepermin alfa ophthalmic solution) contains recombinant human deleted hepatocyte growth factor (dHGF) as its active ingredient. By promoting corneal epithelial regeneration while modulating inflammation and fibrosis, CSB-001 is intended to address the underlying pathophysiology of LSCD. Clinical data to date demonstrate substantial improvements in visual acuity in LSCD patients treated with CSB-001. If approved, CSB-001 has the potential to become the first pharmacologic treatment for LSCD, providing a reliable, accessible, and scalable non-surgical treatment option. Claris and Kringle Pharma, Inc., a company developing oremepermin alfa for non-ophthalmic indications, have a safety-data sharing collaboration that has enabled a more efficient development of oremepermin alfa. Estimates indicate that at least 30,000 LSCD patients in the U.S. are actively being managed by an eye care professional, although given the lack of diagnosis, the number is likely larger. Ongoing and Planned CSB-001 Clinical Studies Proof-of-Concept Study. An open-label clinical study evaluating the safety and efficacy of CSB-001 eyedrops in 63 LSCD subjects is ongoing. Subjects receive CSB-001 investigational eye drops in either one or both eyes over 20 weeks beginning on Day 0, or at Week 20 after a 20 week observational period. Completion of dosing is followed by an observational period. More information can be found at clinicaltrials.gov (NCT06452316): Pivotal Studies. In 1H 2027, Claris plans to initiate two pivotal studies evaluating the safety and efficacy of CSB-001 compared to vehicle in a total of approximately 400 LSCD subjects. The primary efficacy endpoint will be visual acuity supported by anatomical endpoints. Non-Interventional Study. To prepare for the planned pivotal studies, Claris is currently conducting a prospective non-interventional study in subjects with LSCD. This study will provide insights into the natural history of LSCD and characterize real-world LSCD management patterns, and identify and qualify investigative sites and potential study participants for the planned pivotal studies. More information can be found at clinicaltrials.gov (NCT07636590): About Claris Bio Claris Biotherapeutics is a late-stage biopharmaceutical company dedicated to advancing transformative therapies for sight-threatening conditions where no or limited treatment options exist. With an initial focus on limbal stem cell deficiency (LSCD), a blinding disease, we are developing the first pharmacologic treatment with the potential to provide a reliable, accessible, and scalable non-surgical treatment option, while moving medical management beyond today's palliative care and towards meaningful improvements in vision and ocular surface health. Our near-term plan is to advance our lead therapeutic candidate, CSB-001 (oremepermin alfa ophthalmic solution), into LSCD pivotal studies in the first half of 2027, with a longer-term goal to become a leader in developing new therapies that improve vision and change patients’ lives. Foundational intellectual property for Claris was based on the scientific work of Drs. Reza Dana, MD, MSc, MPH, and Sunil Chauhan, DVM, PhD., both from the Massachusetts Eye and Ear and the Harvard Medical School Department of Ophthalmology. To learn more, visit . Media Contact Jordyn Temperato LifeSci Communications jtemperato@lifescicomms.com