Apellis provides update on review of rare safety events with SYFOVRE

Apellis Pharmaceuticals provided an update on its review of rare events of retinal vasculitis reported in real-world treatment with SYFOVRE for geographic atrophy secondary to age-related macular degeneration. Apellis has been conducting a thorough evaluation following these reported events, including a review of the SYFOVRE manufacturing process and drug product and of the safety data from the company’s Phase 3 clinical trials of SYFOVRE. There were no changes in the formulation of the product between Phase 3 clinical trials and commercial supply. Based on this review, there is no indication that drug product or manufacturing issues contributed to these events, and there were no new safety findings in the clinical trials upon secondary review. Specifically: No manufacturing related issues impacting product quality were identified; No quality issues and no contaminants were discovered; No single manufacturing lot was implicated; No indication of drug related immunogenicity was observed in the clinical trial data; Zero events of retinal vasculitis were reported by investigators or identified by an independent reading center in the Phase 3 clinical trials. In addition Apellis re-reviewed all intraocular inflammation cases and confirmed no vasculitis events; External retina/uveitis specialists re-reviewed all severe IOI cases and further confirmed no vasculitis events; Apellis is working closely with the retina community as it continues to investigate potential contributing factors and plans to continue to provide updates. Since launch, Apellis has in total seven confirmed events of retinal vasculitis as determined by Apellis’ internal safety committee and external retina/uveitis specialists. Two of these events followed injections in April, two in May, and three in June. Apellis is also evaluating one reported event of retinal vasculitis, which the company has not confirmed. Apellis can only review and confirm cases that have been reported directly to the company and will continue to submit all reported adverse events to the U.S. Food and Drug Administration consistent with reporting guidelines for drug manufacturers.