Apellis Offers Update on Eye Treatment Safety Issues

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Prompted by recent reports of retinal vasculitis being linked to Syfovre, its recently approved eye injection treatment, Apellis has provided an update on its own review of potential manufacturing issues. According to a company press release, evidence suggests manufacturing issues did not play a role in the cases of retinal vasculitis.

In the aforementioned report, Apellis also confirmed the following findings:

• 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.

Manufactured for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), Syfovre was initially approved by the FDA in February.

“The safety of patients has always been – and continues to be – our top priority at Apellis,” said Cedric Francois, MD, PhD, co-founder, CEO, Apellis, in the company press release. “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.”

Reference: Apellis Provides Update on Review of Rare Safety Events with SYFOVRE® (pegcetacoplan injection) for Geographic Atrophy. Apellis. July 29, 2023. Accessed August 1, 2023. https://investors.apellis.com/news-releases/news-release-details/apellis-provides-update-review-rare-safety-events-syfovrer