WALTHAM, Mass.—Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company, 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, according to an announcement from the company, a leading cause of blindness that impacts more than 1 million people in the U.S. as well as 5 million people worldwide.

“The approval of Syfovre is the most important event in retinal ophthalmology in more than a decade,” said Eleonora Lad, MD, PhD, 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, MD, PhD, 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.”

 
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.

“For the first time ever, we are celebrating the approval of a treatment for GA,” said Jeff Todd, president and chief executive officer, Prevent Blindness. “This is a historic and hopeful day for all GA patients and their care partners, who have been waiting for a treatment for this relentless form of vision loss.”

Syfovre is expected to be available by the beginning of March through specialty distributors and specialty pharmacies nationwide. A marketing authorization application for Syfovre is under review by the European Medicines Agency with a decision expected in early 2024. In addition, a marketing application has been submitted to Health Canada.