The FDA granted priority review for a new drug application for avacincaptad pegol for the treatment of geographic atrophy secondary to age-related macular degeneration, according to an Iveric Bio press release.
The submission was supported by positive 12-month efficacy and safety results from the phase 3 GATHER1 and GATHER2 pivotal clinical trials, in which avacincaptad pegol demonstrated observed efficacy rates of up to 35% for the treatment of geographic atrophy (GA).
The FDA has set a Prescription Drug User Fee Act goal date of Aug. 19. No potential review issues (Read more...)