FDA Approves First Treatment for Geographic Atrophy, Accepts NDA for Same Indication

The FDA has approved Apellis Pharmaceuticals’ Syfovre (pegcetacoplan) injection as the first approved therapy to treat geographic atrophy secondary to age-related macular degeneration, a leading cause of blindness.

The approval was based on results from two phase 3 studies, with Syfovre showing reductions in the growth rate of geographic atrophy lesions and increasing treatment effects over time.

The FDA has also granted a priority review to another potential treatment for the same condition, Iveric Bio’s avacincaptad pegol, which the agency previously designated as a Breakthrough Therapy.

Iveric Bio’s new drug application (NDA) is supported by efficacy rates of up to 35 percent in two phase 3 trials. The FDA’s target decision date for the NDA is Aug. 19.