In what’s been described as “the most important event in retinal ophthalmology in more than a decade”, the first-ever drug to treat geographic atrophic age-related macular degeneration (dry AMD) has been approved for use in the United States.
Apellis Pharmaceuticals said the US Food and Drug Administration has approved pegcetacoplan injection (Syfovre) as the first and only treatment for geographic atrophy (GA) secondary to AMD.
AMD is a leading cause of blindness and severe vision loss. Until now there has been no treatment for the ‘dry’ form of the disease.
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, Apellis said in a news release.
“The approval of Syfovre is the most important event in retinal ophthalmology in more than a decade,” said Dr Eleonora Lad, lead investigator for the OAKS study, director of ophthalmology clinical research, associate professor of ophthalmology, Duke University Medical Center.
Apellis CEO and co-founder Dr Cedric Francois said the approval of Syfovre in the United States was “an extraordinary milestone for patients, the retina community, and 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,” he said.
The FDA approval for Syfovre is 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 rate of GA lesion growth compared to sham and demonstrated increasing treatment effects over time, with the greatest benefit (up to 36% reduction in lesion growth with monthly treatment in DERBY) occurring between months 18–24.
