The FDA accepted a new drug application for intravitreal pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration and granted priority review designation, according to a press release.
The NDA submission was based on results from the phase 2 FILLY study at 12 months and the phase 3 DERBY and OAKS studies at 12 months and 18 months, according to Apellis Pharmaceuticals. The studies resulted in a clinically meaningful reduction of geographic atrophy (GA) lesion growth in more than 1,500 patients following intravitreal pegcetacoplan dosed monthly or