Key Takeaways

  • Two Retina Society presentations will examine phase 2 vision outcomes and phase 3 baseline characteristics for vonaprument in geographic atrophy
  • The ongoing 659-patient ARCHER II trial uses confirmed BCVA loss of at least 15 letters as its primary endpoint, with assessments through months 15 and 24
  • Annexon expects the month 15 primary analysis from ARCHER II in the fourth quarter of 2026

Annexon announced that investigators will deliver two oral presentations evaluating vonaprument in geographic atrophy (GA) at The Retina Society 59th Annual Scientific Meeting, being held September 23-26, 2026, in Los Angeles.

The presentations will focus on findings from the phase 2 ARCHER study and baseline characteristics of participants enrolled in the ongoing phase 3 ARCHER II trial. According to Annexon, the analyses support the clinical development strategy for vonaprument as a potential vision-protecting treatment for patients with GA secondary to dry age-related macular degeneration (AMD).

Vonaprument, formerly known as ANX007, is an investigational antigen-binding fragment designed to selectively inhibit C1q, the initiating molecule of the classical complement pathway. The intravitreally administered candidate is intended to protect photoreceptors and retinal function by blocking C1q and the classical complement pathway while leaving the lectin and alternative complement pathways intact.

Ashkan Abbey, MD, of Texas Retina Associates, will present “Baseline Characteristics of Participants in the Phase 3 ARCHER II Trial in Dry AMD With GA” on September 25 at 9:10 am PT.

Annexon said the presentation will examine the replication of key baseline clinical characteristics between participants in the Phase 2 ARCHER and Phase 3 ARCHER II studies. Maintaining similar characteristics between the study populations is part of the company's strategy for determining whether the vision findings observed in the earlier trial can be confirmed in a larger Phase 3 population.

A second presentation, scheduled for 9:13 am PT on September 25, will examine vision outcomes among ARCHER participants with subfoveal retinal pigment epithelium (RPE) lesions. Mark Barakat, MD, FASRS, of Retina Macula Institute of Arizona, will present the post hoc analysis.

The completed Phase 2 ARCHER trial (NCT04656561) evaluated vonaprument in a broad population of patients with GA. Annexon reported that treatment demonstrated protection of visual function and ellipsoid zone retinal structure across multiple measures, including time- and dose-dependent effects on confirmed loss of at least 15 letters of best-corrected visual acuity (BCVA).

According to the company, vonaprument was generally well tolerated through month 12, with no increase in choroidal neovascularization rates compared with sham and no reported retinal vasculitis events.

ARCHER II (NCT06510816) is a global phase 3 study enrolling 659 patients. The trial was designed to evaluate whether the findings from ARCHER can be replicated, with confirmed BCVA loss of at least 15 letters serving as the primary endpoint through months 15 and 24.

Annexon said the month 15 primary analysis is expected in the fourth quarter of 2026. The company has established a registration pathway with US and European regulators, and the single ARCHER II protocol is also designed to permit analysis as 2 substudies after the primary endpoint is met.

Vonaprument has received Fast Track designation from the FDA and Priority Medicines designation from the European Medicines Agency for GA.