Cancer Drugs Erdafitinib, Pemigatinib Cause Dry Eye

Recent study shows FGFR inhibitors, such as erdafitinib and pemigatinib cause ocular adverse events: corneal thinning, ocular toxicity and xerophthalmia, and serous retinal detachment and subretinal fluid, which prompt the need for patients to be proactively monitored. Photo: Janssen. Click image to enlarge. Dysregulation in fibroblast growth factor receptor (FGFR) signaling is a known mechanism of multiple cancerous malignancies, and hence a newer target of therapy. Use of FGFR inhibitors expands, there is increasing recognition of class-specific toxicities that require careful monitoring. In a recent pharmacovigilance study, researchers from Canada used data from the FDA Adverse Event Reporting System to characterize real-world ocular adverse events (AEs) associated with three FGFR inhibitors: erdafitinib, pemigatinib and futibatinib. Their findings were reported recently in American Journal of Ophthalmology.Of the 1,582 total adverse events linked to these drugs between April 2019 and June 2025, 200 (12.6%) were ocular in nature. Among the affected patients, 562 were male, 414 were female and 606 lacked sex information. The United States accounted for most AEs (73.9%) in the database, followed by France (8.2%), Canada (2.5%) and other countries (15.4%).Erdafitinib accounted for the majority of ocular AEs (75%), demonstrating the strongest signals for corneal and retinal toxicity, including corneal thinning, ocular toxicity and xerophthalmia.Pemigatinib accounted for 22% of reported AEs and was primarily associated with retinal fluid disorders and serous detachments, such as serous retinal detachment and subretinal fluid.Only one ocular AE was reported for futibatnib—dry eye—though it was also vaguely reported to have been associated with retinal disorders with no other ocular surface symptoms observed.The FDA labels for erdafitinib and pemigatinib include a narrow range of ocular AEs, with erdafitinib reported to cause dry eye in 28% of patients, central serous retinopathy/retinal pigment epithelial detachment (PED) in 25%, blurry vision in 17% and increased lacrimation in 10% of patients. The findings in this study for erdafitinib align with these results. Similarly, the FDA label for pemigatinib reports dry eye in 31% of patients, blurry vision in 21%, trichiasis in 18% and PED in 11% of patients. Some of these AEs are reflected in the current study’s findings, specifically regarding the disproportionately higher reporting of dry eye, PED and ocular discomfort. Futibatinib is reported to cause dry eye in 15% and PED in 9% of patients, and this study similarly found increased reporting of dry eye associated with it.However, this study identified AEs for erdafitinib beyond those reported in the FDA labels, such as xerophthalmia, ulcerative keratitis, corneal thinning, chorioretinopathy and maculopathy. For pemigatinib, the researchers identified additional ocular AEs beyond the FDA label that included  “subretinal fluid, retinal detachment, serous retinal detachment, ocular discomfort and ocular hyperemia,” the authors wrote in their paper, but they did not identify PED as an ocular AE of futibatinib despite it being mentioned by the FDA label, likely because only symptomatic AEs were included in the FDA Adverse Event Reporting System.Overall, the researchers stated, these findings align with existing clinical trial data but also identify additional real-world post-marketing signals not captured in pre-approval studies. “These results support the necessity of proactive, ongoing ophthalmic monitoring for patients receiving FGFR inhibitors,” they wrote in their paper.“Patients should be counseled on common side effects—such as dry eye and increased lacrimation—and advised that while retinal disorders may occur, they typically resolve upon treatment discontinuation,” the authors concluded.Click here for the journal source. Osba AA, Ahmad S, Osba RA, et al. Ocular safety signals of fibroblast growth factor receptor inhibitors in post-marketing surveillance. Amer J Ophthalmol. May 24, 2026. [Epub ahead of print.] This article was developed by the editorial staff in conjunction with experts in the field. In the process, AI may have been among the editorial tools used to meet the goals of human editors, who approved all content.