19 November 2024 - Astellas today announced the US FDA issued a complete response letter on 15 November 2024, regarding the supplemental new drug application for Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy secondary to age-related macular degeneration. 

The sNDA sought to include positive two year data in the US Prescribing Information for Izervay based on results from the GATHER2 Phase 3 clinical trial, which evaluated the efficacy and safety of monthly and every other month dosing through year 2.

Read Astellas press release