IVERIC Bio Completes Rolling NDA Submission For Avacincaptad Pegol - Quick Facts

(RTTNews) - IVERIC bio, Inc. (ISEE) has submitted to the FDA the third and final part of its New Drug Application for rolling review of avacincaptad pegol for the treatment of geographic atrophy secondary to Age-Related Macular Degeneration. The NDA submission is based on the 12-month pre-specified primary efficacy and safety results from the GATHER1 and GATHER2 clinical trials.

"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 Sblendorio, Chief Executive Officer of Iveric Bio.

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