GlobeNewswire News Room·2025-07-24 11:00Core Insights - The completion of enrollment in the Phase 3 ARCHER II trial for vonaprument indicates strong demand for a therapy aimed at preserving vision in patients with dry age-related macular degeneration (AMD) with geographic atrophy (GA) [1][4] - Topline pivotal data from the trial is expected to be reported in the second half of 2026, with the potential for vonaprument to be the first approved treatment for dry AMD with GA in Europe and the U.S. [1][10] Company Overview - Annexon, Inc. is a biopharmaceutical company focused on developing novel therapies for neuroinflammatory diseases, including those affecting the eye [1][13] - The company aims to deliver first-in-kind medicines that address significant unmet needs in various therapeutic areas, including autoimmune, neurodegenerative, and ophthalmic diseases [13] Product Details - Vonaprument is a first-in-kind, non-pegylated antigen-binding fragment designed to inhibit C1q locally in the eye, demonstrating significant vision preservation in previous trials [2][9] - The Phase 2 trial showed that vonaprument provided statistically significant protection against vision loss, measured by best corrected visual acuity (BCVA) [11] Trial Design and Objectives - The ARCHER II trial is a global, randomized, double-masked, sham-controlled study that has enrolled over 630 patients, with a primary endpoint focused on preventing a ≥15-letter loss in BCVA [3][6] - Secondary endpoints include safety, low-luminance visual acuity (LLVA), and photoreceptor integrity [8] Regulatory Designations - Vonaprument has received Priority Medicine (PRIME) designation in Europe and Fast Track designation in the U.S., indicating its potential therapeutic advantages [3][10] Market Need - There is an urgent need for effective treatments for GA, as current options are limited and no approved therapies have demonstrated significant prevention of vision loss [5][12]