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

Two weeks after receiving FDA approval, the European Medicines Agency (EMA) has accepted for regulatory review Iveric Bio's 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), according to Astellas Pharma, the parent company of Iveric Bio. 

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 FDA as Izervay (avacincaptad pegol) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) on August 4, 2023. To view EyewireTV's coverage of the approval, including an exclusive interview with Iveric Bio President Pravin Dugel, MD, click here.