| アブストラクト | BACKGROUND: Dry eye disease (DED) is a common ocular surface disorder with limitations in conventional therapies. Perfluorohexyloctane ophthalmic solution, a novel formulation, has demonstrated short-term efficacy, but real-world safety data are insufficient. This study aimed to conduct a pharmacovigilance analysis using the FDA Adverse Event Reporting System (FAERS) database to provide evidence-based references for clinical rational drug use, risk management, and long-term DED treatment strategies. METHODS: We conducted a retrospective pharmacovigilance study using FAERS data from the fourth quarter of 2023 through the fourth quarter of 2024, focusing on adverse events (AEs) associated with perfluorohexyloctane ophthalmic solution for DED. Four disproportionality analysis methods, the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS), were employed to identify potential safety signals. RESULTS: A total of 92 AEs reports associated with perfluorohexyloctane ophthalmic solution for DED were identified. At the Preferred Term (PT) level, the top five reports by count included product delivery mechanism issue, eye irritation, inappropriate schedule of product administration, vision blurred, and ocular hyperaemia. The top five AEs meeting positive signal criteria were wrong dose, exposure via skin contact, patient dissatisfaction with treatment, product dose omission in error, and circumstance or information capable of leading to medication error. The median time-to-onset for perfluorohexyloctane-related AEs was 2 days. CONCLUSION: Overall, the available FAERS data do not raise major safety concerns for perfluorohexyloctane ophthalmic solution in the treatment of DED. The reported AEs appear to be mostly related to the instillation process, user experience with the delivery device, or the initial adaptation period, rather than directly attributable to the drug itself. Larger post-marketing studies are warranted to further characterize the safety profile of perfluorohexyloctane ophthalmic solution. |
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