The European Medicines Agency has selected Annexon’s experimental drug vonaprument (formerly ANX007) to participate in its Product Development Coordinator pilot, a new program designed to provide enhanced regulatory support to Priority Medicine (PRIME) projects. Vonaprument is an intravitreal therapy intended for dry age-related macular degeneration (AMD) with geographic atrophy (GA). The drug, a nonpegylated antigen-binding fragment, targets C1q to inhibit the classical complement pathway in the eye. It has received PRIME designation in Europe and Fast Track status from the US Food and Drug Administration.

The pilot program assigns a dedicated coordinator to guide companies through regulatory processes, respond to ad hoc questions, and assist with evidence planning. Annexon is among about 20 PRIME programs chosen for the initiative.

Vonaprument is in the global phase 3 ARCHER II trial, which has enrolled more than 630 patients. Participants are randomized to receive monthly injections of the drug or a sham procedure, with the main goal of preventing a loss of at least 15 letters on a standard eye chart over 12 months. Secondary measures include low-luminance visual acuity and photoreceptor integrity. Top-line data from ARCHER II are expected in the second half of 2026. RP