Apellis Releases Update on Retinal Vasculitis Associated with Pegcetacoplan Injection

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Apellis Pharmaceuticals has shared an update on the launch of pegcetacoplan injection (SYFOVRE) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD), including an update on the events of retinal vasculitis associated with the therapy.¹

Announced on October 5, the news release includes new updates on safety events since the last update in August. At that time, the company provided an update on injection kits with the use of pegcetacoplan injection and confirmed 8 events of retinal vasculitis.²

In February, pegcetacoplan injection became the first therapy by the US Food and Drug Administration for the treatment of GA.³ Per the GALE extension study data at 30 months, the safety profile of pegcetacoplan injection is consistent with previously reported phase 3 data in the OAKS and DERBY trials. Estimates suggest the real-world rate of retinal vasculitis is rare at 0.01% per injection.

To this date, there have been 10 confirmed events of retinal vasculitis (7 occlusive 3 non-occlusive) and 2 suspected events.¹ Since the previous update, there was 1 new confirmed event that occurred in early August and 2 new suspected events from August and September. Of the 2 events previously considered “suspected”, the company confirmed 1 event while the other was adjudicated to not be retinal vasculitis.

Within the confirmed retinal vasculitis events, 6 patients have recovered vision either fully or partially, while 3 patients have severe vision impairment unlikely to be resolved, and 1 outcome is still pending. Vision outcomes in both suspected events are additionally pending. All suspected events are independently evaluated and adjudicated by 2 external sources, including 4 retina/uveitis experts and an independent reading center.

All identified reported adverse events are submitted by Apellis to the FDA, and the company is in communication with the American Society of Retina Specialists (ASRS) on these reported cases of retinal vasculitis.

“I think it’s important to know that there is a risk of retinal vasculitis or occlusive vasculitis when using pegcetacoplan, so it’s important to consent your patients to the risk,” Dilsher Dhoot, MD of California Retina Consultants told HCPLive at the ASRS 41st Annual Meeting.² “In my own practice, I’m still using pegcetacoplan. However, I’m cautious, I’m not doing bilateral injections from the start.”

In addition, the release noted the permanent J-code is effective as of October, enabling accurate and efficient reimbursement of pegcetacoplan injection.¹ The company indicates 93% of Medicare Advantage payers and 100% of fee-for-service payers now cover pegcetacoplan injection, with an estimated 94% of the US population with GA covered by Medicare.

In Q3 of 2023, approximately 37,000 commercial vials and 10,000 samples of pegcetacoplan injection were distributed to clinical practices. Since launch, more than 100,000 total vials of pegcetacoplan injection have been distributed.

“It is very encouraging to see the return to weekly growth in demand as physicians and patients have learned more about the long-term efficacy from the GALE study and real-world safety of SYVFOVRE,” said Adam Townsend, chief commercial officer of Apellis, in the release. “With our permanent J-code now in place, we look forward to building on these trends and continuing to bring SYFOVRE to people living with this chronic disease.”

References

1. Apellis announces preliminary U.S. net revenues of approximately $74 million for SYFOVRE® (pegcetacoplan injection) in the third quarter of 2023. Apellis Pharmaceuticals, Inc. October 5, 2023. Accessed October 10, 2023. https://investors.apellis.com/news-releases/news-release-details/apellis-announces-preliminary-us-net-revenues-approximately-74.
2. Iapoce C. APELLIS shares update on Pegcetacoplan injection kits, retinal vasculitis events. HCP Live. August 23, 2023. Accessed October 10, 2023. https://www.hcplive.com/view/apellis-update-pegcetacoplan-injection-kits-retinal-vasculitis-events.
3. Iapoce C. FDA approves Pegcetacoplan Injection for geographic atrophy. HCP Live. February 17, 2023. Accessed October 10, 2023. https://www.hcplive.com/view/fda-approves-pegcetacoplan-injection-geographic-atrophy.