other material
confidence high
sentiment negative
materiality 0.75
Apellis updates on 8 retinal vasculitis events with SYFOVRE; recommends switching to 18-gauge filter needle
Apellis Pharmaceuticals, Inc.
- Over 100,000 SYFOVRE vials distributed; 8 confirmed retinal vasculitis events (5 occlusive, 3 non-occlusive) as of June 20.
- Last confirmed event on June 20; over 32,000 vials distributed since then with no new confirmed events.
- One additional occlusive event in May reported after July 29; all events occurred after first injection.
- Company recommends discontinuing use of 19-gauge filter needle kits; now exclusively distributing 18-gauge filter needle kits.
- Patient outcomes: 1 stable, 2 near baseline, 2 severe vision impairment, 3 pending; two suspected events also reported.