| アブストラクト | OBJECTIVE: To evaluate the postmarketing ocular adverse events (AEs) reported for intravitreal antivascular endothelial growth factor (anti-VEGF) therapies, aflibercept (2 mg and 8 mg), and faricimab (6 mg). DESIGN: Retrospective pharmacovigilance analysis. PARTICIPANTS: Food and Drug Administration Adverse Event Reporting System (FAERS) database. METHODS: We conducted a retrospective pharmacovigilance analysis of the FAERS database from the fourth quarter of 2023 to the first quarter of 2025. Descriptive statistics and reporting odds ratio (ROR) analysis were employed to evaluate and compare AEs between 2 mg aflibercept, 8 mg aflibercept, and faricimab. RESULTS: A total of 462 unique reports of AEs secondary to 2 mg aflibercept, 151 reports for 8 mg aflibercept, and 2 427 reports for faricimab were identified. Ocular AEs that were disproportionately over-reported for all of the 3 agents included intraocular injection complications, increased intraocular pressure, endophthalmitis, reduced visual acuity, eye inflammation, uveitis, visual impairment, and blurred vision. CONCLUSIONS: In this study, faricimab generally showed lower point estimates for ROR of ocular AEs compared to 2 mg and 8 mg aflibercept; however, the wider confidence intervals for some outcomes reflect the limited number of reports and highlight the need for continued safety monitoring, particularly given the inherent reporting biases and lack of detailed patient or dosing information in the FAERS database. |
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| ジャーナル名 | Canadian journal of ophthalmology. Journal canadien d'ophtalmologie |
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| Pubmed追加日 | 2026/3/16 |
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| 投稿者 | Zonouzi, Sara Kamali; Balas, Michael; Arjmand, Parnian |
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| 組織名 | School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.;Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto,;ON.;ON; Mississauga Retina Institute, Mississauga, ON; School of Medicine, Toronto;Metropolitan University, Toronto, ON. Electronic address:;Parnian.arjmand@utoronto.ca. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41833326/ |
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