ASRS investigation uncovers link between pegcetacoplan and retinal vasculitis complications

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In a recent investigation by the American Society of Retina Specialists (ASRS) Research and Safety in Therapeutics (ReST) Committee, a concerning association has been identified between intravitreal pegcetacoplan injections and cases of retinal vasculitis. The retrospective review focused on post-marketing reports of patients who experienced this rare complication after receiving the drug.

The study involved an expert panel’s comprehensive examination of cases reported to the ASRS, with a particular emphasis on clinical and imaging characteristics. The results revealed that out of the analyzed cases, 14 eyes of 13 patients were confirmed to have retinal vasculitis. All instances occurred after the initial administration of pegcetacoplan.

Occlusive retinal vasculopathy was observed in most cases, affecting 11 eyes (79%). The median time between pegcetacoplan injection and the presentation of vasculitis symptoms was 10.5 days, with a range of 8 to 23 days. Notably, all eyes exhibited anterior chamber inflammation, and the majority (86%) also displayed vitritis.

The vasculopathy primarily involved retinal veins (100%) more than arteries (73%), accompanied by retinal hemorrhages in 86% of cases. Visual acuity (VA) demonstrated a significant decline from baseline to vasculitis presentation and throughout the follow-up period. The median VA was 20/60 at baseline, 20/300 at vasculitis presentation, and 20/200 at the last follow-up.

More than half of the affected eyes (57%) experienced a greater than 3-line decrease in VA, and 43% suffered a more than 6-line decrease from baseline to the final follow-up. Two eyes had to be enucleated due to the severity of complications.

Furthermore, 43% of the cases developed signs of anterior segment neovascularization.

Witkin AJ, Jaffe GJ, Srivastava SK, et al. Retinal Vasculitis After Intravitreal Pegcetacoplan: Report From the ASRS Research and Safety in Therapeutics (ReST) Committee. J Vitreoretin Dis. 2023;8(1):9-20. doi: 10.1177/24741264231220224. PMID: 38223782; PMCID: PMC10786078.