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Apellis Pharmaceuticals’ Syfovre is a pegcetacoplan injection intended for the treatment of geographic atrophy secondary to age-related macular degeneration.
Apellis Pharmaceuticals, a global biopharmaceutical company, announced FDA approval of Syfovre (pegcetacoplan injection) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) on Feb. 17, 2023. The first and only FDA-approved treatment for GA, according to a company press release, approval of pegcetacoplan injection was based on positive Phase III clinical trial results from two studies (OAKS and DERBY) that found it reduced the rate of GA lesion growth compared to sham.
GA is an advanced form of AMD that is characterized by the growth of lesions that destroy the retinal cells responsible for vision. According to the press release, it is a leading cause of blindness affecting more than one million people in the United States and five million worldwide.
“The approval of [Syfovre] is the most important event in retinal ophthalmology in more than a decade,” said Eleonora Lad, lead investigator for the OAKS study, director of ophthalmology clinical research, associate professor of ophthalmology, Duke University Medical Center, in the press release. “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, co-founder and CEO, Apellis, in the release. “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 treatment is expected to be available in the US via specialty distributors and pharmacies by the beginning of March 2023. Similar regulatory applications are currently under review by the European Medicines Agency and Health Canada.