Adverse events associated with brolucizumab: a disproportionality analysis of the FDA adverse event reporting system (FAERS).

Abstract

Background: The safety information of brolucizumab primarily comes from clinical trials experience. This study aimed to explore the ocular and systemic adverse events (AEs) associated with brolucizumab among real-world patients through data mining the FDA Adverse Event Reporting System (FAERS) database.

Methods: AE reports submitted to the FAERS database between October 2019 and March 2023 were extracted. The reporting odds ratio was used to evaluate AE signals associated with brolucizumab.

Results: There were 4,380,839 AE reports extracted from the FAERS database, and 3,313 of which were with brolucizumab as primary suspected. A total of 150 ocular AE signals were identified. Ninety-nine were known ocular AEs listed in brolucizumab' label, primarily including vision-related AEs, intraocular infections, and retinal disorders. Fifty-one were unexpected ocular AE signals, including keratic precipitates, retinal perivascular sheathing, dry eye, glaucoma, etc. Meanwhile, several serious systemic AE signals, including arterial thromboembolic events and rhinorrhea, were also identified.

Conclusions: Several unexpected ocular and systemic AE signals associated with brolucizumab were identified through data mining of the FAERS database.