Real-World Safety Profile of Cenegermin Per FDA Adverse Event Reporting System

Purpose: To characterize the safety profile of cenegermin through an analysis of postmarket adverse events (AEs). Methods: The U.S. Food and Drug Administration adverse event reporting system was queried for AEs associated with cenegermin use between 2019 and 2023. Demographic information was collected. Reporting odds ratio (ROR) and proportional reporting ratio (PRR) were used to determine adverse reactions that were significantly more likely to be caused by cenegermin use compared with other ophthalmical topicals. Results: Most AEs occurred in females (65.16%). The most common AEs were eye pain (46.94%), irritation (14.46%), and ocular hyperemia (9.8%). Of 34 eye disorders that were found to be associated with cenegermin use, the ones with the highest odds ratios were periorbital pain [ROR: 25.34, confidence interval (CI): 20.70-31.01, PRR: 16.45], eyelid pain (ROR: 22.96, CI: 19.39-27.19, PRR: 15.50), and eye pain (ROR: 20.02, CI: 18.77-21.35, PRR: 16.08). Patients taking cenegermin were significantly more likely to develop eye disorders (ROR: 2.21, CI: 2.12-2.31, PRR: 1.46), but were not more likely to develop disorders of other system organ classes. In terms of patient outcomes, patients taking cenegermin were at higher risk for hospitalization (ROR: 16.39, CI: 12.84-20.94, PRR: 12.17) and surgery (ROR: 9.57, CI: 6.14-14.93, PRR: 8.01). Conclusion: Postmarket surveillance of cenegermin demonstrates that eye pain and irritation are the most common AEs. Involvement of other organ systems is highly unlikely. Patients using topical cengermin should be counseled accordingly.