Iveric Submits 1st Part of NDA for Rolling Review

 IVERIC bio, Inc. (Nasdaq: ISEE) today announced that it has submitted to the U.S. Food and Drug Administration (FDA) the first part of its New Drug Application (NDA) for rolling review of avacincaptad pegol (ACP, also known as Zimura®) a novel investigational complement C5 inhibitor, for the treatment of geographic atrophy (GA) secondary to Age-Related Macular Degeneration (AMD). As previously announced, the Company received Fast Track designation from the FDA for ACP. Following receipt of the topline GATHER2 data, the Company shared the data with the FDA. Based on the pivotal clinical trials, GATHER1 and GATHER2, which both met their primary endpoint in slowing GA progression with statistical significance at the 12-month time point, the Company requested rolling submission of its planned NDA, which the FDA granted. As per the Company’s agreement with the FDA, the first part of the NDA, which included the complete ACP clinical data package, was successfully submitted earlier today.

https://finance.yahoo.com/news/iveric-bio-announces-submission-first-223000569.html