Ocular adverse events of cenegermin used in neurotrophic keratopathy: an analysis of the FDA adverse event reporting system database

ABSTRACT

Background

Cenegermin, a recombinant human nerve growth factor, is an orphan drug approved for neurotrophic keratitis. The safety information on the label is incomplete, and the adverse reactions noted are mostly mild and tolerable. However, the occurrence of painful epithelial plagues and irreversible corneal deposits after cenegermin usage have been reported. Real-world data on long-term ocular safety are lacking. We aimed to assess the cenegermin-associated eye safety profile in the FDA pharmacovigilance database.

Methods

The signals of cenegermin-related ocular adverse events (AEs) from 2018 to 2022 were quantified using the reporting odds ratio (ROR) and information component (IC). The grading system was used to prioritize the signals.

Results

We identified 3288 cases of cenegermin-related ocular AEs and 56 positive ocular-related signals. Fifty unexpected signals of ocular AE were identified. Eye ulcer was classified as a designated medical event. Twenty AEs, including corneal perforation, eye infection, corneal deposits, and eye inflammation, were recognized as important medical event. The median onset time for ocular AEs was 6 days (interquartile range [IQR]: 1–29 days).

Conclusion

This study revealed new cenegermin-related ocular AE signals. Clinical practice requires close monitoring to early identify and manage adverse reactions that may cause occurrence of serious irreversible consequences.

KEYWORDS:

• Cenegermin
• drug safety
• FDA adverse event reporting system
• neurotrophic keratitis
• pharmacovigilance

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

One reviewer was a PI for one of the US study sites – they personally did not see many of these side effects however it is important to note. The remaining reviewers have no other relevant financial relationships or otherwise to disclose.

Author contribution statement

Weimin He and Yunfei Li designed the study. Yunfei Li and Haiyun Yang performed the data analysis. Yunfei Li, Haiyun Yang and Yuan Gao managed and checked all the data and wrote the manuscript. Weimin He, Yunfei Li and Yuan Gao revised and edited the manuscript. Weimin He provided guidance and feedback on all aspects of the study and supervised the study. All authors read, checked, and approved the final manuscript.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2023.2251389

Additional information

Funding

This paper was not funded.