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. 2023 Dec 21;8(1):9-20.
doi: 10.1177/24741264231220224. eCollection 2024 Jan-Feb.

Retinal Vasculitis After Intravitreal Pegcetacoplan: Report From the ASRS Research and Safety in Therapeutics (ReST) Committee

Andre J Witkin  1 , Glenn J Jaffe  2 , Sunil K Srivastava  3 , Janet L Davis  4 , Judy E Kim  5
Affiliations

Retinal Vasculitis After Intravitreal Pegcetacoplan: Report From the ASRS Research and Safety in Therapeutics (ReST) Committee

Andre J Witkin et al. J Vitreoretin Dis. .

Erratum in

Abstract

Purpose: To analyze post-marketing cases of retinal vasculitis after intravitreal pegcetacoplan. Methods: 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. Results: Fourteen eyes of 13 patients were 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 eyes (79%). Patients presented a median of 10.5 days (range, 8-23 days) after pegcetacoplan injection. All eyes had anterior chamber inflammation, and 12 eyes (86%) had vitritis. Vasculopathy involved retinal veins (100%) more than arteries (73%), and 12 eyes (86%) had retinal hemorrhages. The median visual acuity (VA) was 20/60 (range, 20/30-5/200) at baseline, 20/300 (range, 20/100-no light perception [NLP]) at vasculitis presentation, and 20/200 (range 20/70-NLP) at the last follow-up. Eight eyes (57%) had more than a 3-line decrease in VA, and 6 eyes (43%) had more than a 6-line decrease in VA from baseline to the final follow-up, including 2 eyes that were enucleated. Six eyes (43%) developed signs of anterior segment neovascularization. Conclusions: There is currently no known etiology for vasculitis in this series. Optimum treatment strategies remain unknown. Infectious etiologies should be considered, and corticosteroid treatments may hasten resolution of inflammatory findings. Continued treatment of affected patients with pegcetacoplan should be avoided.

Keywords: Syfovre; age-related macular degeneration; geographic atrophy; intraocular inflammation; occlusive; pegcetacoplan; retinal vasculitis; vasculitis.

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Conflict of interest statement

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article:Dr. Witkin is a principal investigator for Regeneron and Apellis. Dr. Kim is on the advisory board of Amgen, Apellis, Bausch + Lomb, and Coherus and is a consultant to Bayer, Genentech/Roche, and Regeneron. Dr. Jaffe is a consultant to Roche/Genentech, Annexon, Regeneron, and Boehringer-Ingelheim. Dr. Srivastava has received research funding from Regeneron and is a consultant to Regeneron, Bausch + Lomb, Eyepoint, Allergan, Adverum, Novartis, and RegenxBio. Dr. Davis has received grants from the National Eye Institute ADVISE and ADJUST trials and Gyroscope and is a consultant to Kodiak Science, 4D Molecular Therapeutics, and Aura Biosciences. Dr. Kaiser has received research grant support from Apellis (Digital Angiography Reading Center), has stock options with Ocular Therapeutix, and is a consultant to Allergan/Abbvie, Stealth Biotherapeutics, Bausch + Lomb, Novartis, Bayer, Regeneron, Ocular Therapeutix, Allegro, Alzheon, Annexon Biosciences, Beohringer Ingelheim, Carl Zeiss Medtec, Clearside Biomedical, Complement Therapeutics, DelSiTech, Galimedix, and Iveric Bio. Dr. Ali is on the speakers’ bureau of Apellis and Iveric Bio, is on the advisory board of OcuTerra, and is a consultant to Allergan/Abbvie, Apellis, Genentech, Iveric Bio, Optomed, and Regeneron. Dr. Arevalo has received research grant support from Topcon Medical Systems Inc and is a consultant to THEA Laboratories, Alimera Sciences Inc, and Iveric Bio. Dr. Choudhry is on the advisory board of Novartis, Topcon Medical Systems Inc, Bayer, Apellis, and Optos PLC and is a consultant to Novartis, Roche Pharma, Bausch + Lomb, Alcon, J&J, Apellis, Allergan/Abbvie, and Viatris. Dr. Jain is a principal investigator for Janssen Pharmaceuticals and Ocugen Inc. Dr. Schneider is a principal investigator for Carl Zeiss Meditec, Oxurion, and Regeneron and is a consultant to Carl Zeiss Meditec and Notal Vision. Dr. Vajzovic is a principal investigator for AGTC, Alcon, Aldeyra, Gyroscope, Heidelberg Engineering, Janssen, Novartis, Ocular Therapeutix, RegenexBio, and Roche/Genentech; is on the advisory board of Clearside Biomedical; and is a consultant to Alcon, Alimera Sciences, Allergan/Abbvie, Apellis, Bausch + Lomb, Iveric Bio, Ocugen, and Roche/Genentech. Dr. Vora is on the speakers’ bureau of Iveric Bio, Disease State Education (nonpromotional), and is a consultant to Outlook Therapeutics and Paradigm Biopharmaceuticals. Dr. Yonekawa is a primary investigator for Genentech, Kodiak, and Regeneron and is a consultant to Alcon, EyePoint, and Versant Health. Dr. Leder declared no potential conflicts of interest with respect to the research, authorship, and/or publication of the article.

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