BRISBANE, Calif., July 14, 2026
Annexon announced that new analyses from its Phase 2 ARCHER trial evaluating vonaprument in patients with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD) will be presented during an oral session at the American Society of Retina Specialists (ASRS) 2026 Annual Scientific Meeting. The presentation will examine baseline characteristics associated with confirmed best corrected visual acuity (BCVA) loss of 15 or more ETDRS letters, providing insights that support patient selection for the ongoing pivotal Phase 3 ARCHER II study, with topline results expected in the fourth quarter of 2026.
Phase 2 ARCHER Demonstrated Significant Vision Preservation
The completed Phase 2 ARCHER trial previously showed that vonaprument significantly preserved visual function in patients with geographic atrophy. The investigational therapy achieved statistically significant, time- and dose-dependent reductions in confirmed BCVA 15-letter vision loss, a clinically meaningful endpoint widely accepted by global regulatory authorities. Additional benefits were observed across other prespecified measures of visual function, including low luminance visual acuity (LLVA) and low luminance visual deficit (LLVD), while optical coherence tomography (OCT) demonstrated preservation of photoreceptor integrity and retinal structure. Vonaprument also maintained a favorable safety profile through 12 months, with no increase in choroidal neovascularization (CNV) or cases of retinal vasculitis.
Phase 3 ARCHER II Trial Progresses Toward Pivotal Readout
The ongoing global ARCHER II Phase 3 trial has enrolled 659 patients with geographic atrophy and is evaluating intravitreal vonaprument against sham treatment. The primary endpoint measures the proportion of patients experiencing confirmed BCVA loss of at least 15 ETDRS letters at two consecutive visits through Month 15. Secondary endpoints include safety, low luminance visual acuity, and preservation of photoreceptor integrity. Annexon has established a global regulatory pathway with both the U.S. Food and Drug Administration (FDA) and European regulators, with pivotal topline results anticipated in Q4 2026.
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Vonaprument Targets Complement-Mediated Neurodegeneration
Vonaprument (formerly ANX007) is a first-in-class, non-pegylated antigen-binding fragment (Fab) designed to selectively inhibit C1q, the initiating molecule of the classical complement pathway implicated in neurodegeneration associated with geographic atrophy. By blocking C1q while preserving the lectin and alternative complement pathways, the therapy is designed to protect photoreceptors and preserve retinal function without disrupting normal immune activity. Vonaprument has received FDA Fast Track Designation and is the first investigational therapy for geographic atrophy to receive European Medicines Agency (EMA) PRIME Designation, supporting its continued development as a potential vision-preserving treatment for patients with GA.
Source: Annexon, press release
