Clinical Updates — Clinical Updates

New ReST Committee Report Published in JVRD Summarizes Analysis of Reported Cases of Retinal Vasculitis Following Syfovre Injection

The Journal of VitreoRetinal Diseases has published Retinal Vasculitis After Intravitreal Pegcetacoplan: Report From the ASRS Research and Safety in Therapeutics (ReST) Committee in the newly released January/February 2024 issue.

On February 17, 2023, pegcetacoplan 15mg (Syfovre – Apellis Pharmaceuticals, Waltham MA) was approved by the US Food and Drug Administration (FDA) to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Beginning in April 2023, the American Society of Retina Specialists (ASRS) Research and Safety in Therapeutics (ReST) Committee began receiving reports of intraocular inflammation (IOI) following intravitreal pegcetacoplan administration. In addition to cases of IOI without retinal vascular involvement, several reported cases included retinal vasculitis resulting in occlusive retinal vasculopathy and significant vision loss. The American Society of Retina Specialists (ASRS) Research and Safety in Therapeutics (ReST) Committee, as well as an expert panel, performed a retrospective review of cases of retinal vasculitis reported to the ASRS. Clinical and imaging characteristics were reviewed for evidence of retinal vasculitis and analyzed.

As of January 16, 2024, fourteen eyes of 13 patients have been confirmed to have retinal vasculitis by review of imaging studies. All cases occurred after the first pegcetacoplan injection. Occlusive retinal vasculopathy was confirmed in 11 (79%) eyes. Patients presented a median of 10.5 days (range 8-23 days) after pegcetacoplan injection. Vasculopathy involved retinal veins more than arteries, and most eyes had retinal hemorrhages. At the most recent follow-up, eight (57%) eyes had >3 line decrease in VA, and six (43%) eyes had >6 line decrease in VA from baseline at final follow-up, including 2 eyes that were enucleated. Six eyes (43%) developed signs of anterior segment neovascularization. 

The new report also offers a summary of the ReST Committee's analysis of post-approval cases of retinal vasculitis reported to the ASRS through April 1, 2020. Click here to read the report.

The ASRS will continue to keep the retina community updated with available information and asks physicians to report any Syfovre-related adverse events to the ASRS, FDA, and Apellis. As always, the ASRS encourages active vigilance and reporting of all drug-and device-related adverse events.
(Published Jan. 16. 2024)