Astellas Pharma Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted the revised supplemental New Drug Application (sNDA) for IZERVAY (avacincaptad pegol intravitreal solution). This application pertains to the treatment of geographic atrophy (GA) associated with age-related macular degeneration (AMD). The resubmission follows the FDA's Complete Response Letter (CRL) received in November 2024.
Astellas refilled the application after a meeting with the FDA on December 20, 2024. It has been designated as a Class 1 resubmission, which entails a 60-day review period. The expected decision date is set for February 26, 2025.
Initially, IZERVAY received FDA approval on August 4, 2023, for treating geographic atrophy related to macular degeneration. The current sNDA aims to incorporate positive two-year data from the GATHER2 Phase 3 clinical trial into the IZERVAY U.S. Prescribing Information.
