European Medicines Agency Accepts Iveric Bio’s Marketing Authorization Application for Avacincaptad Pegol for Geographic Atrophy

Astellas Pharma Inc. announced the European Medicines Agency (EMA) has accepted for regulatory review the marketing authorization application (MAA) for avacincaptad pegol (ACP), an investigational complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The Committee for Medicinal Products for Human Use (CHMP) of the EMA will start its review of the MAA under the centralized licensing procedure for all 27 member states of the European Union (EU).

GA is a form of AMD that can cause irreversible vision loss. Without timely treatment, an estimated 66% of people with GA may become blind or severely visually impaired. Globally, approximately 5 million people are estimated to have GA at least in one eye.

Pravin U. Dugel, MD, President, Iveric Bio, An Astellas Company
“This acceptance of our EU Marketing Authorization Application is a key milestone in our global effort to help patients living with GA, a leading cause of blindness worldwide. We look forward to collaborating with CHMP throughout the review process and hope to make ACP available for patients in Europe.”

The MAA is based on the GATHER1 and GATHER2 Phase 3 clinical trials, which evaluated the safety and efficacy of monthly 2 mg intravitreal administration of ACP in patients with GA secondary to AMD. In each registrational trial, over a 12-month period, the primary analysis showed a statistically significant reduction in the rate of GA growth in patients treated with ACP compared to sham. Across the GATHER1 and GATHER2 clinical trials, safety was evaluated in over 700 patients with GA.

ACP was approved by the U.S. Food and Drug Administration as IZERVAY (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) on August 4, 2023.

This acceptance of the EU Marketing Authorization Application will have no impact on the financial forecasts of the current fiscal year ending March 31, 2024.