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# FDA to Review Iveric NDA for Avacincaptad Pegol
- URL: https://www.fdaweb.com/fda-to-review-iveric-nda-for-avacincaptad-pegol/
- Published: 2023-02-17T12:00:00.000Z
- Updated: 2026-09-14T18:16:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153807

FDA has accepted an Iveric Bio NDA for avacincaptad pegol, described as a novel investigational complement CS inhibitor for treating geographic atrophy secondary to age-related macular degeneration. The company [says](https://investors.ivericbio.com/news-releases/news-release-details/iveric-bio-announces-fda-accepts-new-drug-application-and-grants?ref=fdaweb.com) the PDUFA action date on the NDA is 8/19\. The agency granted priority review of the NDA.

Iveric says it has been advised that at this time FDA has not identified any potential review issues and is not planning to convene an advisory committee to consider the NDA.

The submission is based on the 12-month pre-specified primary efficacy and safety results from the GATHER1 and GATHER2 clinical trials, the company says.

Iveric says avacincaptad pegol is the only investigational product to treat geographic atrophy to achieve the pre-specified 12-month primary endpoint in two Phase 3 pivotal trials with observed efficacy rates of up to 35%. It also is the only investigational therapy to receive FDA’s Breakthrough Therapy designation for geographic atrophy secondary to age-related macular degeneration, Iveric says.