Apellis Pharmaceuticals Inc. provided an update on its review of rare events of retinal vasculitis reported in real-world treatment with pegcetacoplan injection (SYFOVRE) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Apellis Pharmaceuticals shares soar nearly 14% in premarket trading.
According to a news release, Apellis is presenting seven oral presentations on pegcetacoplan injection and GA during the American Society of Retina Specialists 2023 annual meeting through Tuesday in Seattle. Highlights will include new 30-month safety and efficacy data of pegcetacoplan injection in patients with GA from the GALE long-term extension study.
Cedric Francois, MD, PhD, co-founder and CEO of Apellis, noted that the safety of patients has always been – and continues to be – the top priority at Apellis.
“Following 68,000 commercial vials distributed and 23,000 clinical trial injections to date, these events continue to be very rare,” he said in the company’s news release. “
Francois added that as part of the company’s ongoing review, Apellis has seen no indication that drug product or manufacturing issues contributed to the 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 (Sunday) at the ASRS Annual Scientific Meeting,” he said.
According to the news release, Apellis has been conducting a thorough evaluation following these reported events, including a review of the pegcetacoplan injection manufacturing process and drug product and of the safety data from the Company’s Phase 3 clinical trials of pegcetacoplan injection. 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:
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:
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.
Apellis is also evaluating one reported event of retinal vasculitis, which the Company has not confirmed.
According to the company’s news release, 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.
As of July 29, more than 68,000 vials of SYFOVRE have been distributed since FDA approval, including commercial vials shipped and sample vials distributed to physician practices. In addition, more than 23,000 pegcetacoplan injections have been administered in clinical trials to date.
