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FDA Approves SYFOVRE™ (pegcetacoplan injection) as the First and Only Treatment for Geographic Atrophy (GA), a Leading Cause of Blindness
SYFOVRE slowed GA progression with increasing effects over time Approved for all patients with GA, with dosing flexibility every 25 to 60 days
About this update from Apellis Pharmaceuticals, Inc.
[{"type":"text","content":"SYFOVRE slowed GA progression with increasing effects over time Approved for all patients with GA, with dosing flexibility every 25 to 60 days Well-demonstrated safety profile following ~12,000 injections over 24 months Conference call today at 4:30 p.m. ET A Media Snippet accompanying this announcement is available by clicking on the image or link below: WALTHAM, Mass., Feb. 17, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that the U.S. Food and Drug Administration (FDA) has approved SYFOVRE™ (pegcetacoplan injection) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). SYFOVRE is the first and only FDA-approved treatment for GA, a leading cause of blindness that impacts more than one million people in the U.S. and five million people worldwide.1,2 “The approval of SYFOVRE is the most important event in retinal ophthalmology in more than a decade,” said Eleonora Lad, M.D., Ph.D., lead investigator for the OAKS study, director of ophthalmology clinical research, associate professor of ophthalmology, Duke University Medical Center. “Until now, there have been no approved therapies to offer people living with GA as their vision relentlessly declined. With SYFOVRE, we finally have a safe and effective GA treatment for this devastating disease, with increasing effects over time.” “Today marks an extraordinary milestone for patients, the retina community, and Apellis. With its increasing effects over time and flexible dosing, we believe that SYFOVRE will make a meaningful difference in the lives of people with GA,” said Cedric Francois, M.D., Ph.D., co-founder and chief executive officer, Apellis. “GA is a complex disease that the field has spent decades trying to address, so we are humbled and proud to bring forward the first-ever treatment. Thank you to all who helped make this moment a reality.” The approval of SYFOVRE is based on positive results from the Phase 3 OAKS and DERBY studies at 24 months across a broad and representative population of patients. SYFOVRE is approved for GA patients with or without subfoveal involvement and provides dosing flexibility for patients and physicians with a dosing regimen of every 25 to 60 days. In the OAKS and DERBY studies, SYFOVRE reduced the ra...