Apellis reports 6 retinal vasculitis events after SYFOVRE; rate ~0.01% per injection

Apellis Pharmaceuticals, Inc.

Six retinal vasculitis events observed after first SYFOVRE injection, 7-13 days post-dose; no specific lot implicated.
Estimated event rate ~1 per 10,000 injections (0.01%); approximately 60,000 vials distributed since FDA approval.
Two events confirmed occlusive, one non-occlusive, three undetermined; etiology unclear, outcomes evolving.
Zero retinal vasculitis events in clinical trials (>23,000 injections); FDA notified, no action planned at this time.
Company investigating with ASRS ReST Committee and external specialists; will update as new info emerges.

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