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

Area of Science:

• Ophthalmology
• Pharmacovigilance
• Drug Safety

Background:

• Cenegermin is a topical ophthalmic agent used for ocular surface diseases.
• Understanding its postmarket safety profile is crucial for clinical practice.

Purpose of the Study:

• To characterize the safety profile of cenegermin by analyzing postmarket adverse events (AEs).
• To identify specific adverse reactions associated with cenegermin use compared to other topical ophthalmic treatments.

Main Methods:

• Utilized the U.S. Food and Drug Administration adverse event reporting system (FAERS) for data from 2019-2023.
• Employed Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) to assess the likelihood of AEs with cenegermin.
• Collected demographic information and analyzed reported eye disorders and patient outcomes.

Main Results:

• The most frequent AEs were eye pain (46.94%), irritation (14.46%), and ocular hyperemia (9.8%).
• Significantly higher odds of periorbital pain, eyelid pain, and eye pain were associated with cenegermin use.
• Patients using cenegermin showed increased risk for hospitalization (ROR: 16.39) and surgery (ROR: 9.57).

Conclusions:

• Postmarket surveillance indicates eye pain and irritation are the primary AEs of cenegermin.
• Systemic involvement beyond the eye is unlikely.
• Patients should be counseled on potential ocular AEs and increased risks of hospitalization and surgery.