Posted by Michael Wonder on 17 Aug 2023
European Medicines Agency accepts Iveric Bio’s marketing authorisation application for avacincaptad pegol for geographic atrophy
18 August 2023 - Astellas Pharma today announced the EMA has accepted for regulatory review the marketing authorisation application for avacincaptad pegol, an investigational complement C5 inhibitor for the treatment of geographic atrophy secondary to age-related macular degeneration.
The marketing authorisation application is based on the GATHER1 and GATHER2 Phase 3 clinical trials, which evaluated the safety and efficacy of monthly 2 mg intravitreal administration of avacincaptad pegol in patients with geographic atrophy secondary to age-related macular degeneration.
