Astellas Pharma announced the FDA accepted the revised supplemental new drug application (sNDA) for IZERVAY (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to AMD on Jan. 6, 2025, in response to the Agency's November 2024 Complete Response Letter (CRL). The application was refiled following a Dec. 20, 2024, meeting between the FDA and Astellas and has been designated as a Class 1 resubmission, with a 60-day review period, the company said in a press release. 

A target action date has been set for Feb. 26, 2025.

IZERVAY was approved by the FDA on August 4, 2023, for the treatment of GA secondary to AMD.

According to the company, the sNDA seeks to add positive 2-year data to the IZERVAY U.S. Prescribing Information based on results from the GATHER2 Phase 3 clinical trial.

The impact of this matter on Astellas' financial results for the fiscal year ending March 31, 2025, is expected to be minor, the company said.