Apellis Provides Update on Review of Rare Safety Events with SYFOVRE (pegcetacoplan injection) for Geographic Atrophy

• No indication that drug product or manufacturing issues contributed to rare events of retinal vasculitis
• Confirmed seven total events of non-occlusive/occlusive retinal vasculitis since launch; more than 68,000 SYFOVRE vials distributed to date
  
• Zero events were reported in clinical trials, following more than 23,000 clinical trial injections to date
  

WALTHAM, Mass., July 29, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) (“the Company”) today provided an update on its review of rare events of retinal vasculitis reported in real-world treatment with SYFOVRE (pegcetacoplan injection) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

“The safety of patients has always been – and continues to be – our top priority at Apellis,” said Cedric Francois, M.D., Ph.D., co-founder and chief executive officer of Apellis. “Following 68,000 commercial vials distributed and 23,000 clinical trial injections to date, these events continue to be very rare. Additionally, as part of our ongoing review, we have seen no indication that drug product or manufacturing issues contributed to these events. We will continue to collaborate with the retina community to deliver a safe, effective treatment for GA and look forward to sharing long-term clinical data on SYFOVRE tomorrow at the ASRS Annual Scientific Meeting.”

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 (e.g., endotoxins) 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: