Annexon Completes Enrollment in Phase 3 ARCHER II Trial of Vonaprument for Geographic Atrophy

Annexon has announced the completion of patient enrollment in its Phase 3 ARCHER II trial of vonaprument (formerly ANX007), an investigational treatment for dry age-related macular degeneration (AMD) with geographic atrophy (GA). The company confirmed it remains on track to report topline results in the second half of 2026.

Vonaprument is a first-in-class, non-pegylated antigen-binding fragment (Fab) therapy designed to inhibit C1q, a key activator of the classical complement pathway, through a localized intravitreal injection. According to Annexon, the neuroprotective effect and visual function benefits demonstrated in the Phase 2 ARCHER trial underpin the design of this pivotal study. Notably, vonaprument is the only investigational therapy for GA to show significant preservation of visual function, including improvements in best corrected visual acuity (BCVA) and low luminance visual acuity (LLVA).

Global Study Targeting Regulatory Approvals in US and Europe

ARCHER II is a global, randomized, double-masked, sham-controlled pivotal trial evaluating both functional and structural endpoints to support regulatory filings in both the United States and Europe. Vonaprument has received Priority Medicines (PRIME) designation from the European Medicines Agency and Fast Track designation from the U.S. FDA, reinforcing its potential as a transformative therapy in the field of retinal disease.

“Achieving and surpassing our enrollment goal ahead of schedule in ARCHER II highlights the strong interest for a treatment that can help patients preserve their vision,” said Douglas Love, President and CEO of Annexon. “ARCHER II is designed to confirm the protection of visual acuity and visual structures demonstrated previously in our phase 2 trial, and we look forward to reporting topline pivotal data in the second half of 2026. The power of our classical complement platform continues to achieve differentiated functional benefits across indications, and we remain committed to our goal of making and shaping markets with first-in-kind medicines that will help millions of patients live their best lives.”

Upcoming Data Presentation at ASRS 2025

Further insights into the ARCHER II trial design and clinical rationale will be presented at the upcoming American Society of Retina Specialists (ASRS) Annual Meeting in Long Beach, California.

       • Session: Dry AMD Symposium 2

       • Presentation Title: ARCHER II, a Phase 3 Randomized Clinical Trial of ANX007 in Patients with Dry AMD and GA: Study Design and Rationale Informed by Outcomes From ARCHER

       • Presenter: David A. Eichenbaum, MD, FASRS, Retina Specialist, Retina Vitreous Associates of Florida

       • Date/Time: Thursday, July 31, 2025, at 2:59 PM PT