Phase 3 ARCHER II trial completes enrollment

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The phase 3 ARCHER II trial of vonaprument (formerly ANX007) for dry age-related macular degeneration (AMD) with geographic atrophy (GA) has completed enrollment. This aligns with the previously shared timeline, and Annexon remains on track to report topline data in the second half of 2026.

Vonaprument is a first-in-kind, non-pegylated antigen-binding fragment (Fab) designed to block C1q locally in the eye with an intravitreal formulation. The neuroprotective effect and consistent benefits of C1q inhibition were previously demonstrated by vonaprument in a phase 2 trial.

The Phase 3 ARCHER II trial

According to the company’s press release¹, ARCHER II is a global, randomized, double-masked, sham-controlled pivotal trial that has enrolled more than 630 patients with advanced dry AMD/geographic atrophy (GA). Patients will be randomized 2:1 to receive a monthly dose of vonaprument or sham procedure.

The primary end point is the prevention of ≥15-letter loss of best corrected visual acuity (BCVA), which represents 3 lines on the standard Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart. The primary analysis will occur at least 12 months from dosing initiation. Secondary end points in ARCHER II include safety, low-luminance visual acuity (LLVA), and photoreceptor integrity (EZ). Topline data are expected in the second half of 2026. Vonaprument has received priority medicine (PRIME) designation in Europe and fast track designation in the US.

The ARCHER II trial at ASRS 2025

David Eichenbaum, MD, director of research at the Retina Vitreous Associates of Florida, will give an oral presentation on the design and rationale of the pivotal phase 3 ARCHER II trial at the American Society of Retina Specialists (ASRS) annual meeting held in Long Beach, California.

Eichenbaum, a principal investigator of the ARCHER II trial, is quoted in the company’s press release¹, saying, “The global reach of ARCHER II has increased awareness of vonaprument’s innovative mechanism and compelling phase 2 results. With no approved therapies in Europe and limited options in the US, there is an urgent need for a treatment for GA that protects vision, the most clinically meaningful outcome for patients. I’m encouraged by the robust design of ARCHER II and look forward to helping advance this differentiated therapy worldwide.”

• 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
  • David A. Eichenbaum, MD, FASRS, Retina Specialist, Retina Vitreous Associates of Florida
  • Thursday, July 31 at 2:59 PM Pacific Time (PT)

Reference:

1. Annexon Announces Completion of Enrollment in Pivotal Phase 3 ARCHER II Trial of Vonaprument (formerly ANX007) for Dry Age-Related Macular Degeneration (AMD) with Geographic Atrophy. July 24, 2025. Accessed July 24, 2025. News Release. https://finance.yahoo.com/news/annexon-announces-completion-enrollment-pivotal-110000694.html