Apellis provides update on review of rare safety events with Syfovre for geographic atrophy

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 III clinical trials of Syfovre. There were no changes in the formulation of the product between Phase III 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: i. No manufacturing related issues impacting product quality were identified. ii. No quality issues and no contaminants (e.g., endotoxins) were discovered. iii. No single manufacturing lot was implicated. iv. No indication of drug related immunogenicity was observed in the clinical trial data. v. Zero events of retinal vasculitis were reported by investigators or identified by an independent reading center in the Phase III clinical trials.

In addition: Apellis re-reviewed all intraocular inflammation (IOI) 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.

Apellis also provided an update on the events of retinal vasculitis reported to date: i. Since launch, Apellis has in total seven confirmed events of retinal vasculitis (4 occlusive, 3 non-occlusive) 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. ii. Apellis is also evaluating one reported event of retinal vasculitis, which the Company has not confirmed. iii. 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 FDA consistent with reporting guidelines for drug manufacturers.