Iveric Bio Completes Rolling NDA Submission to FDA for GA Treatment

December 27, 2022

Iveric Bio has submitted to the 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,” Glenn P. Sblendorio, CEO of Iveric Bio, said in a company news release. “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 12-month prespecified primary effectiveness and safety findings from the GATHER1 and GATHER2 clinical trials served as the foundation for the NDA filing. In two phase 3 pivotal trials, ACP, the only experimental therapy for GA, met the predetermined 12-month primary endpoint with reported effectiveness rates as high as 35%. ACP is also the first and only investigational treatment to be designated as a Breakthrough Therapy 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, MD, 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.”