American journal of ophthalmology · 2026
Ocular Safety Signals of Fibroblast Growth Factor Receptor Inhibitors in Postmarketing Surveillance.
СтатьяНазвание и аннотация: Перевод в очереди
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Abu Osba Abdelrahman, Ahmad Syed, Abu Osba Roaa, Hendy Abd El Aziz, Bondok Mostafa, Mihalache Andrew, Kohly Radha P, Wong David, Muni Rajeev H, Popovic Marko M
Аннотация
OBJECTIVE: To evaluate postmarketing ocular adverse events (oAEs) associated with fibroblast growth factor receptor inhibitors (FGFRi).
DESIGN: Population-based pharmacovigilance study.
PARTICIPANTS: Ocular AE reports from the US Food and Drug Administration Adverse Event Reporting System for individuals treated with erdafitinib, pemigatinib, or futibatinib.
METHODS: US Food and Drug Administration Adverse Event Reporting System data from April 19, 2019 to June 30, 2025 were analyzed using OpenVigil 2.1. Disproportionality analyses were conducted to calculate reporting odds ratios for drug-oAE pairs compared with all other drugs.
MAIN OUTCOME MEASURES: Disproportionality of reported ocular AEs among erdafitinib, pemigatinib, and futibatinib.
RESULTS: A total of 1582 FGFR inhibitor-associated adverse events were identified, of which 200 (12.6%) were ocular. Erdafitinib accounted for the majority of ocular adverse events (75%), followed by pemigatinib (22%) and futibatinib (3%). The oAEs reported with the highest disproportionality signal with erdafitinib included corneal thinning (ROR 321; 95% CI 102-1009), ocular toxicity (ROR 225; 95% CI 117-439), and xerophthalmia (ROR 138; 95% CI 44-432). The oAEs with the greatest disproportionality signals with pemigatinib were serous retinal detachment (ROR 180; 95% CI 67-484), subretinal fluid (ROR 165; 95% CI 68-398), and retinal pigment epithelium detachment (ROR 110; 95% CI 35-344). Only 1 oAE was reported for futibatinib, which was dry eye (ROR 36.12; 95% CI 15.76-82.74).
CONCLUSIONS: This pharmacovigilance analysis identified oAEs associated with FGFR inhibitors in real-world use, extending beyond those reported in clinical trials and regulatory labeling. However, findings are hypothesis-generating and reflect disproportional reporting rather than incidence or causal risk.
DESIGN: Population-based pharmacovigilance study.
PARTICIPANTS: Ocular AE reports from the US Food and Drug Administration Adverse Event Reporting System for individuals treated with erdafitinib, pemigatinib, or futibatinib.
METHODS: US Food and Drug Administration Adverse Event Reporting System data from April 19, 2019 to June 30, 2025 were analyzed using OpenVigil 2.1. Disproportionality analyses were conducted to calculate reporting odds ratios for drug-oAE pairs compared with all other drugs.
MAIN OUTCOME MEASURES: Disproportionality of reported ocular AEs among erdafitinib, pemigatinib, and futibatinib.
RESULTS: A total of 1582 FGFR inhibitor-associated adverse events were identified, of which 200 (12.6%) were ocular. Erdafitinib accounted for the majority of ocular adverse events (75%), followed by pemigatinib (22%) and futibatinib (3%). The oAEs reported with the highest disproportionality signal with erdafitinib included corneal thinning (ROR 321; 95% CI 102-1009), ocular toxicity (ROR 225; 95% CI 117-439), and xerophthalmia (ROR 138; 95% CI 44-432). The oAEs with the greatest disproportionality signals with pemigatinib were serous retinal detachment (ROR 180; 95% CI 67-484), subretinal fluid (ROR 165; 95% CI 68-398), and retinal pigment epithelium detachment (ROR 110; 95% CI 35-344). Only 1 oAE was reported for futibatinib, which was dry eye (ROR 36.12; 95% CI 15.76-82.74).
CONCLUSIONS: This pharmacovigilance analysis identified oAEs associated with FGFR inhibitors in real-world use, extending beyond those reported in clinical trials and regulatory labeling. However, findings are hypothesis-generating and reflect disproportional reporting rather than incidence or causal risk.