FDA aligns with Annexon on vision preservation endpoint for ANX007 GA Phase 3 program; ANX1502 Ph1 positive

Annexon, Inc.

FDA agrees to prevention of ≥15-letter BCVA loss as primary endpoint; no requirement for surrogate structural endpoint.
Two Phase 3 trials: ARCHER II (sham-controlled, ~400 pts, starts mid-2024) and ARROW (head-to-head vs Syfovre, ~500 pts, starts late 2024).
ANX007 Phase 2 ARCHER showed 72% risk reduction (p=0.006) in BCVA ≥15-letter loss in monthly dose arm vs sham.
ANX1502 Phase 1 healthy-volunteer data: target drug levels with BID dosing, suppressed C4d biomarker, no serious AEs.
Company plans to advance tablet formulation of ANX1502 into proof-of-concept trial in CAD patients in 2024.

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