Apellis’ Syfovre (pegcetacoplan injection) has become the first US Food and Drug Administration (FDA) -approved treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Syfovre’s approval for GA patients without subfoveal involvement follows positive results from the phase 3 OAKS and DERBY studies at 24 months. According to the authors of both 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. Delivered by intravitreal injection, doses can be spaced at 25- to 60-day intervals.
"Until now, there have been no approved therapies to offer people living with GA as their vision relentlessly declined. The approval of Syfovre is the most important event in retinal ophthalmology in more than a decade," said Associate Professor Eleonora Lad, director of ophthalmology clinical research at Duke University Medical Center, North Carolina, US.
Apellis said single 0.1ml vials will be priced at US$2,190 (NZ$3,518).
