Vorolanib

Charles Wykoff, M.D., Ph.D. joins Carl Regillo, M.D., FACS as co-chair of Scientific Advisory Board Usha Chakravarthy, M.B.B.S, PhD., Allen Ho, M.D. FACS FASRS and Frank Holz, M.D., F.E.B.O, F.A.R.V.O join in advance of global Phase 3 clinical trials for EYP-1901(DURAVYU) in wet AMD Company on track to initiate the first Phase 3 pivotal trial (LUGANO) for DURYVU in wet AMD in 2H 2024 WATERTOWN, Mass., April 02, 2024 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with serious retinal diseases, today announced the appointment of leading global ophthalmologists to its Scientific Advisory Board (SAB), co-chaired by Carl Regillo M.D., FACS, Chief of the Retina Service at Wills Eye Hospital and Charles Wykoff, M.D., Ph.D., Director of Research of Retina Consultants of Texas. The SAB additions include Usha Chakravarthy, M.B.B.S., Ph.D.; Allen Ho, M.D. FACS FASRS, and Frank Holz, M.D., F.E.B.O., F.A.R.V.O. These three world-renowned retinal specialists will support advancement of the Company’s global clinical strategy ahead of the anticipated initiation of its Phase 3 pivotal trials in wet age-related macular degeneration (wet AMD) in the second half of this year. Additionally, the Company announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the trade name, DURAVYUTM (vorolanib intravitreal insert) for the Company’s lead product candidate, EYP-1901. “We are honored to add these prominent leaders of the retina community to our SAB as we approach the topline data readout of the Phase 2 PAVIA trial for non-proliferative diabetic retinopathy later this quarter, and as we prepare for the initiation of our global Phase 3 program in the second half of 2024,” said Ramiro Ribeiro, M.D., Ph.D., Chief Medical Officer of EyePoint. “The SAB’s strategic counsel, global expertise, and scientific knowledge will be incredibly valuable during this critical time in EyePoint’s growth and expansion. The caliber of our expanded SAB speaks to the quality and potential of our programs, and I look forward to this collaboration to further expand our product candidates and to bring novel treatment options to patients globally.” “We are delighted to announce that ‘DURAVYU’ has been conditionally accepted as a proprietary name by the FDA for our lead product candidate, EYP-1901,” said Jay S. Duker, M.D., President and Chief Executive Officer of EyePoint. “This represents another step forward as we continue to advance DURAVYU through clinical development across three significant sight-threatening indications in our efforts to bring a safe and effective therapy with the potential to improve the treatment paradigm for patients.” “Following EyePoint’s strong and convincing Phase 2 DAVIO 2 data for DURAVYU in wet AMD, I am delighted to have these distinguished leaders on the cutting edge of ophthalmic research join the SAB,” said Carl Regillo, M.D., FACS, Co-Chair of EyePoint’s SAB. “I look forward to collaborating with Dr. Wykoff in his expanded role, as well as the renowned members of the SAB and EyePoint management team, as we work to improve the lives of patients with serious retinal diseases.” Usha Chakravarthy, M.B.B.S., Ph.D. Usha Chakravarthy, M.B.B.S., Ph.D. is an Honorary and Emerita Professor of Ophthalmology and Vision Sciences at the Queen’s University of Belfast. She is recognized internationally for her work on age-related macular degeneration (AMD) and diabetic retinopathy. Dr. Chakravarthy has authored or co-authored over 400 publications, and she is invited to lecture in the UK and abroad. She has been involved in many of the major international retina clinical trials as well as co-authored Cochrane Review articles and guidelines for the Royal College of Ophthalmologists on the treatment of AMD. Dr. Chakravarthy has been the recipient of many prestigious awards including the title of Commander in the Most Excellent Order of the British Empire for clinical services to ophthalmology and research. She holds a Ph.D. from Queen’s University of Belfast and an M.B.B.S. from the University of Madras. Allen Ho, M.D.,FACS FASRS Allen Ho, M.D. FACS FASRS is Attending Surgeon, Director of Retina Research and Co-Director of the Retina Service of Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University. He has deep experience in translational clinical research and maintains special interests in macular diseases, diabetic retinopathy, surgical retinal diseases and clinical trials, investigating new treatments for vitreoretinal diseases. Dr. Ho has authored over 300 peer reviewed publications and several textbooks. He has been a principal investigator on numerous major clinical trials developing new medical and surgical treatments for retinal disorders. Dr. Ho is the recipient of numerous awards including from the American Academy of Ophthalmology, multiple retina societies and the American Diabetes Association, and he is a perennial awardee of national Castle Connolly awards. He was also named in the Ophthalmologist Power List of the top 100 most influential ophthalmologists in the world. Dr. Ho holds an M.D. from Columbia University College of Physicians and Surgeons and a B.A. from Cornell University. Frank Holz, M.D., F.E.B.O., F.A.R.V.O. Frank Holz, M.D., F.E.B.O., F.A.R.V.O. is a professor and chairman of the Department of Ophthalmology at the University of Bonn in Germany. He founded the Medical Imaging Center Bonn (MIB), the GRADE Reading Center Bonn and was a co-founder of the Priority Program AMD of the German Research Council. He has published over 600 articles in peer-reviewed journals and has authored or co-authored more than 20 book chapters on age-related macular degeneration, medical retina and retinal imaging. Dr. Holz is the recipient of multiple local, national and international awards including the Pro Retina Macular Degeneration Research Award, the Leonhard-Klein Award for Ocular Surgery, the Alcon Research Institute (ARI) Award, the Senior Achievement Award of the AAO and the Jules Gonin Award. He is a Board Member of the German Ophthalmological Society, and of the Club Jules Gonin and is past president of EURETINA. Dr. Holz trained at the University of Heidelberg, the University of Chicago Pritzker School of Medicine and completed a fellowship at Moorfields Eye Hospital, London. DURAVYU™ has been conditionally accepted by the FDA as the proprietary name for EYP-1901. DURAVYU is an investigational product; it has not been approved by the FDA. FDA approval and the timeline for potential approval is uncertain. About EyePoint Pharmaceuticals EyePoint Pharmaceuticals (Nasdaq: EYPT) is a clinical-stage biopharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious retinal diseases. The Company's pipeline leverages its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery. The Company’s lead product candidate, EYP-1901 (DURYVU™), is an investigational sustained delivery treatment for VEGF-mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with Durasert E™. Pipeline programs include EYP-2301, a promising TIE-2 agonist, razuprotafib, f/k/a AKB-9778, formulated in Durasert E™ to potentially improve outcomes in serious retinal diseases. The proven Durasert® drug delivery technology has been safely administered to thousands of patient eyes across four U.S. FDA approved products. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts. Vorolanib is licensed to EyePoint exclusively by Equinox Sciences, a Betta Pharmaceuticals affiliate, for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong and Taiwan. Forward Looking Statements EYEPOINT PHARMACEUTICALS SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the use of proceeds for the offering and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, this includes statements about the sufficiency of our existing cash resources through topline data for Phase 3 clinical trials for EYP-1901 (DURAVYU™) in wet AMD; our expectations regarding the timing and clinical development of our product candidates, including DURAVYU and EYP-2301; the potential for DURAVYU as a novel sustained delivery treatment for serious eye diseases, including wet age-related macular degeneration (wet AMD) and non-proliferative diabetic retinopathy (NPDR) and diabetic macular edema (DME); the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals including potential U.S. Food and Drug Administration (FDA) regulatory approval of DURAVYU and EYP-2301; the success of current and future license agreements; our dependence on contract research organizations, co-promotion partners, and other outside vendors and service providers; the success of Durasert® as a drug delivery platform in FDA approved products; product liability; industry consolidation; compliance with environmental laws; risks and costs of international business operations; volatility of stock price; possible dilution; absence of dividends; the impact of general business and economic conditions; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; manufacturing risks; and other factors described in our filings with the Securities and Exchange Commission. We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. A variety of factors, including these risks, could cause our actual results and other expectations to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. Investors: Christina Tartaglia Stern IR Direct: 212-698-8700 christina.tartaglia@sternir.com Media Contact: Amy Phillips Green Room Communications Direct: 412-327-9499 aphillips@greenroompr.com