| アブストラクト | OBJECTIVE: To evaluate the postmarketing ocular adverse events (AEs) reported for avacincaptad pegol and pegcetacoplan, the only Food and Drug Administration (FDA)-approved treatments for geographic atrophy (GA). DESIGN: Retrospective pharmacovigilance analysis. SUBJECTS: Ocular AE reports in the FDA Adverse Event Reporting System (FAERS) in which pegcetacoplan or avacincaptad pegol was identified as the primary suspect drug were analyzed. METHODS: Using the OpenVigil 2.1 data mining software, we conducted a retrospective pharmacovigilance analysis of the FAERS database from inception to December 2024. We conducted disproportionality analyses to assess reporting odds ratios (RORs) for specific drug-AE combinations compared with all other drugs in the database. MAIN OUTCOME MEASURES: Ocular AEs were evaluated. RESULTS: A total of 752 and 80 patients with AEs secondary to pegcetacoplan and avacincaptad pegol, respectively, were identified. Ocular AEs disproportionately overreported for pegcetacoplan included anterior segment (iris) hemorrhage (ROR 1767, 95% CI 538-5803), iris neovascularization (ROR 1248, 95% CI 502-3099), choroidal neovascularization (ROR 1328, 95% CI 956-1845), intraocular injection complication (ROR 2552, 95% CI 1607-4053), hemorrhagic occlusive retinal vasculitis (ROR 4606, 95% CI 2000-10,611), retinal occlusive vasculitis (ROR 2352, 95% CI 1313-4212), and bacterial endophthalmitis (ROR 1260, 95% CI 613-2589). Ocular AEs disproportionately overreported for avacincaptad pegol included choroidal neovascularization (ROR 1169, 95% CI 426-3205), vitritis (ROR 782, 95% CI 316-1936), dry age-related macular degeneration (ROR 684, 95% CI 316-1936), and cystoid macular edema (ROR 445, 95% CI 140-1412). CONCLUSIONS: Current prescribing patterns indicate that a broader spectrum of ocular AEs were reported for pegcetacoplan than avacincaptad pegol. These findings aim to enhance clinicians' understanding of the safety profiles of these agents, enabling informed patient care and heightened vigilance of these novel GA treatments. |
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| ジャーナル名 | American journal of ophthalmology |
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| Pubmed追加日 | 2025/4/28 |
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| 投稿者 | Kailani, Zeena; Mihalache, Andrew; Popovic, Marko M; Kertes, Peter J; Muni, Rajeev H |
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| 組織名 | From the Michael G. DeGroote School of Medicine, McMaster University (Z.K.),;Hamilton, Ontario, Canada.;Temerty Faculty of Medicine, University of Toronto (A.M.), Toronto, Ontario,;Canada.;Stein Eye Institute and Doheny Eye Institute, David Geffen School of Medicine,;University of California, Los Angeles (M.M.P.), Los Angeles, California, USA;;Department of Ophthalmology and Vision Sciences, University of Toronto (M.M.P.,;P.J.K., R.H.M.), Toronto, Ontario, Canada.;P.J.K., R.H.M.), Toronto, Ontario, Canada; The John and Liz Tory Eye Centre,;Sunnybrook Health Sciences Centre (P.J.K.), Toronto, Ontario, Canada.;P.J.K., R.H.M.), Toronto, Ontario, Canada; Department of Ophthalmology, St.;Michael's Hospital, Unity Health Toronto (R.H.M.), Toronto, Ontario, Canada..;Electronic address: rajeev.muni@utoronto.ca. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40288597/ |
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