| アブストラクト | OBJECTIVE: Anti-VEGF therapies have transformed the management of neovascular age-related macular degeneration, diabetic macular edema, and macular edema secondary to retinal vein occlusion. This class-wide pharmacovigilance study evaluated the disproportionality of reported ocular adverse events (AEs) among anti-VEGF agents using postmarketing data. DESIGN: A population-based, observational pharmacovigilance study. PARTICIPANTS: Reports from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database (January 2004-September 2024) for individuals treated with anti-VEGF agents. METHODS: Ocular AEs were identified from FAERS, and disproportionality was assessed by comparing each anti-VEGF agent to background reporting using reporting odds ratios (RORs, 95% confidence interval [CI]); signals were considered significant if information component (IC(025)) > 0. Ranibizumab, aflibercept, brolucizumab, and faricimab were evaluated to compare ocular AE profiles among agents. MAIN OUTCOME MEASURES: Disproportionality of reported ocular AEs among anti-VEGF agents. RESULTS: Across included patients receiving anti-VEGF agents with ocular AEs, most were female and aged 65 to 85 years. When comparing intraocular inflammation (IOI) signals across anti-VEGF agents, the strongest association was observed with brolucizumab (ROR = 633.32), followed by faricimab (ROR = 156.44), aflibercept (ROR = 51.29), and ranibizumab (ROR = 16.90). Faricimab was notably associated with elevated disproportionality signals for reports of anterior segment inflammation, including anterior chamber flare (ROR = 270.95), unspecified anterior chamber inflammation (ROR = 226.28), iridocyclitis (ROR = 214.60), and iritis (ROR = 88.90). For posterior segment involvement, increased reporting of vitritis was observed with brolucizumab (ROR = 1769.33), faricimab (ROR = 466.99), aflibercept (ROR = 165.31), and ranibizumab (ROR = 56.67). Rare but clinically significant complications were reported across all agents, including for reports of endophthalmitis (aflibercept ROR = 208.88, ranibizumab ROR = 114.69, faricimab ROR = 99.75, and brolucizumab ROR = 56.15), noninfectious endophthalmitis (aflibercept, ROR = 846.11, 244.42 for brolucizumab, 65.45 for ranibizumab, and 59.08 for faricimab), and pseudoendophthalmitis, which showed the strongest signal with faricimab (ROR = 262.31; all 95% CI = 29.37-649.50, P < 0.0001, IC(025) > 0). Faricimab also demonstrated increased reporting of retinal vascular inflammation but showed comparatively lower signals for noninflammatory occlusive events and other serious ocular complications relative to other anti-VEGF agents. CONCLUSIONS: This global pharmacovigilance study revealed variability in ocular AE reporting across anti-VEGF agents. Brolucizumab showed the strongest signal for IOI, whereas aflibercept showed the highest signal for endophthalmitis. Continued postmarketing monitoring is warranted to define evolving safety profiles across anti-VEGF agents. FINANCIAL DISCLOSURE(S): The authors have no proprietary or commercial interest in any materials discussed in this article. |
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| 組織名 | Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada; The;University of Ottawa Eye Institute, Ottawa, Ontario, Canada.;The University of Ottawa Eye Institute, Ottawa, Ontario, Canada.;Department of Ophthalmology and Visual Sciences, University of Toronto, Toronto,;Ontario, Canada.;Department of Ophthalmology and Visual Sciences, University of Alberta, Edmonton,;Alberta, Canada; Department of Ophthalmology and Visual Sciences, Aga Khan;University, Karachi, Pakistan.;The University of Ottawa Eye Institute, Ottawa, Ontario, Canada. Electronic;address: bhurley@toh.ca. |
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