Annexon Selected by EMA to Participate in Product Development Coordinator Pilot for Vonaprument (ANX007) for Dry Age-Related Macular Degeneration with Geographic Atrophy

Core Insights - Annexon, Inc. announced that its product vonaprument has been selected by the European Medicines Agency (EMA) for the Product Development Coordinator (PDC) pilot, which aims to enhance regulatory support for promising therapies [1][4] - Vonaprument is positioned to potentially be the first approved treatment for dry age-related macular degeneration (AMD) with geographic atrophy (GA) in both Europe and the U.S., focusing on preserving visual acuity and visual structures [1][2] Company Overview - Annexon, Inc. is a biopharmaceutical company dedicated to developing novel therapies for neuroinflammatory diseases affecting the body, brain, and eye, with a focus on classical complement-mediated conditions [1][10] - The company’s approach targets C1q, a key molecule in the classical complement pathway, which is implicated in neurodegeneration [10] Product Development - Vonaprument is a first-in-kind, non-pegylated antigen-binding fragment designed to block C1q locally in the eye, showing significant vision preservation in clinical trials [2][6] - The product has received both Priority Medicine (PRIME) designation in Europe and Fast Track designation from the U.S. FDA, indicating its potential therapeutic advantages [2][7] Clinical Trials - The ongoing Phase 3 ARCHER II trial has enrolled over 630 patients with advanced dry AMD/GA, with a primary endpoint focused on preventing a ≥15-letter loss in best corrected visual acuity (BCVA) [5][8] - Topline data from the ARCHER II trial is expected in the second half of 2026, following the completion of patient enrollment in July 2025 [4][5] Market Context - Dry AMD and GA are significant causes of blindness in the elderly, affecting approximately one million people in the U.S. and eight million globally, highlighting the urgent need for effective treatments [9] - Current approved therapies have not demonstrated significant efficacy in preventing vision loss, underscoring the potential market opportunity for vonaprument [9]