Iveric bio completes NDA submission to FDA for avacincaptad pegol to treat GA

IVERIC bio announced that it has submitted to the U.S. Food and Drug Administration FDA the third and final part of its New Drug Application, NDA for rolling review of avacincaptad pegol, ACP, a novel investigational complement C5 inhibitor for the treatment of geographic atrophy GA secondary to Age-Related Macular Degeneration, AMD. Per the company’s agreement with the FDA for rolling NDA review, part 3 of the NDA included chemistry, manufacturing, and controls data. "We are excited to have submitted our complete NDA for avacincaptad pegol with a request for priority review based on our Breakthrough Therapy designation," said Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. "We continue to accelerate our launch preparations with the goal of making a treatment available as soon as possible for AMD patients impacted by GA, a disease that leads to irreversible blindness." "We are thrilled with the statistically significant efficacy and consistent safety results from both the GATHER1 and GATHER2 pivotal clinical trials," said Pravin U. Dugel, President of Iveric Bio. "Our Special Protocol Assessment Agreement for GATHER2, rolling review, Breakthrough Therapy designation and priority review request are intended to expedite the review process and get avacincaptad pegol to GA patients, who currently have no treatment options. We look forward to collaborating with the FDA throughout the NDA review process."