FDA accepts Iveric Bio's Zimura NDA for priority review

The US Food and Drug Administration (FDA) has completed its filing review and accepted the company’s New Drug Application (NDA) for Zimura (avacincaptad pegol; ACP), a novel investigational complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), says US biopharma Iveric Bio (Nasdaq: ISEE), whose shares rose 7.5% to $20.00 in pre-market trading this morning.

The NDA has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of August 19, 2023. The company also announced that, at this time, the FDA has not identified any potential review issues and the FDA is not currently planning to hold an Advisory Committee meeting for ACP.

“The FDA’s acceptance of our NDA and Priority Review for avacincaptad pegol bring us another significant step closer to delivering a much-needed treatment to AMD patients living with GA,” said Glenn Sblendorio, chief executive of Iveric Bio. “We look forward to continuing our collaboration with the FDA throughout the review process.”