Wednesday, December 21, 2022
IVERIC bio, Inc., 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.”
The NDA submission is based on the 12-month pre-specified primary efficacy and safety results from the GATHER1 and GATHER2 clinical trials. ACP is the only investigational product for treatment of GA to achieve the pre-specified 12-month primary endpoint in two phase 3 pivotal trials with observed efficacy rates of up to 35%. In addition, ACP is the first and only investigational therapy to receive Breakthrough Therapy designation for GA secondary to AMD.
“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.”