The FDA has granted breakthrough therapy designation to Zimura for the treatment of geographic atrophy secondary to age-related macular degeneration, according to a press release from Iveric Bio.
Zimura (avacincaptad pegol), a complement C5 inhibitor, is the first investigational therapy to receive the status of breakthrough therapy designation for this indication. The designation is based on positive 12-month primary efficacy endpoint data from the GATHER1 and GATHER2 pivotal clinical trials, which demonstrated observed efficacy rates of up to 35% (P = .0050 for GATHER1) and 18% (P = .0039