other material
confidence high
sentiment negative
materiality 0.80
Apellis updates SYFOVRE label to include rare retinal vasculitis risk; rate 0.01% per injection
Apellis Pharmaceuticals, Inc.
- Updated USPI Warnings/Precautions and Postmarketing Experience sections to include retinal vasculitis with/without occlusion.
- Estimated rate of retinal vasculitis remains rare at 0.01% per injection, based on over 120,000 injections administered as of Nov 18, 2023.
- Label update pursued in collaboration with the FDA.