Data Readout

Annexon's ARCHER II Sets Up Q4 Test of Vision Loss, Not Growth

The Phase 3 trial in geographic atrophy will report whether vonaprument slows BCVA loss, the first time visual preservation has anchored a pivotal readout in this disease.

By AppliedXLJuly 13, 2026Trial NCT06510816

Executive Summary

Annexon's pivotal geographic atrophy trial has finished enrolling and is heading toward a topline readout that will test whether its complement-targeting injection can preserve vision, not just slow anatomical lesion growth, the metric most prior programs in this disease have chased.
No other program in geographic atrophy has reached Phase 3 with visual acuity loss as its primary endpoint, which means the result will be judged without a same-design precedent to compare against.
The trial completed enrollment at its target count and shifted to an active, non-recruiting status without any enrollment shortfall, removing execution risk as a factor in whether the readout lands on schedule.
Geographic atrophy has no therapy proven to preserve visual function, so a result that shows a clear separation from sham on vision loss, sustained through month 15, would be the type of finding that could reset how the field defines a meaningful treatment effect.

The trial

ARCHER II (NCT06510816) is a global, sham-controlled, double-masked Phase 3 study of intravitreal vonaprument (formerly ANX007) in 659 adults with geographic atrophy secondary to dry age-related macular degeneration. The primary endpoint measures the proportion of patients experiencing a confirmed best corrected visual acuity (BCVA) loss of 15 or more letters from baseline through month 15, assessed by the ETDRS chart at two consecutive visits. Annexon's chief executive Douglas Love called ARCHER II "the first study to evaluate visual preservation as the primary endpoint in patients with GA and the first pivotal study with an aligned global regulatory path". NCT06510816+1

Probability of Success

Endpoint Met75%

Completes76%

Clinical Significance60%

Regulatory65%

Timing and disclosure history

The company has guided to a Q4 2026 topline data window since March 2026 and reaffirmed it in a subsequent quarterly update, with the window running from October 1 through December 31, 2026. The trial's registered primary completion date sits at October 31, 2026, inside that guided window. The completion date shifted once, from October 1 to October 31, 2026, in a November 2024 registry update, a change that predates enrollment completion and carries no bearing on the current guidance. Annexon+1

Enrollment and status

Enrollment finished at 659 patients, up from an earlier registered target of 630, a change the trial's own operational baseline classifies as within the routine range and not a signal of distress. The trial moved from Recruiting to Active, not recruiting in November 2025, the status change that normally accompanies enrollment completion at the planned target. Annexon said enrollment completed in July 2025. NCT06510816+1

The competitive field

No other clinical program targets C1q in geographic atrophy, and ARCHER II is the only Phase 3 trial built around visual-acuity loss as its primary measure in this disease. The broader geographic atrophy field includes eight active industry trials spanning early Phase 1 through Phase 3, with programs targeting C5 (Regeneron's cemdisiran) and CD59 (Janssen's JNJ-81201887), among other mechanisms, none of which shares vonaprument's target or uses visual-acuity loss as a primary endpoint. Because no direct comparator exists, the readout will be judged against sham control within its own design rather than against a same-mechanism precedent.

Regulatory context

Vonaprument holds Fast Track designation from the FDA and PRIME designation from the European Medicines Agency, the first geographic atrophy program to receive PRIME, according to Annexon's disclosures. These designations reflect unmet need in geographic atrophy and expedited engagement with regulators; they do not indicate how the trial's endpoint will read out. Annexon

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.