Ophthalmology. Retina · 2025
Association of Anti-VEGF Therapy with Reported Ocular Adverse Events: A Global Pharmacovigilance Analysis.
СтатьяНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Lakhani Moiz, Kwan Angela T H, Kundapur Deeksha, Popovic Marko M, Damji Karim F, Hurley Bernard R
Аннотация
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 (IC025) > 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, IC025 > 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.
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 (IC025) > 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, IC025 > 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.
Предметные рубрики MeSH
HumansPharmacovigilanceVascular Endothelial Growth Factor AAngiogenesis InhibitorsFemaleMaleAgedRanibizumabIntravitreal InjectionsRecombinant Fusion ProteinsAdverse Drug Reaction Reporting SystemsUnited StatesReceptors, Vascular Endothelial Growth FactorWet Macular DegenerationRetinal Vein OcclusionAged, 80 and overMacular EdemaRetrospective StudiesMiddle AgedAntibodies, Monoclonal, Humanized