# Real-world landscape of drug-related ocular injuries: a retrospective pharmacovigilance study

## TL;DR

This study identifies drugs linked to eye injuries using FDA data, highlighting high-risk medications and patient groups to improve safe drug use.

## Contribution

The study detects new drug-ocular injury risk signals and characterizes their epidemiology using FAERS data.

## Key findings

- Brolucizumab, macrogol 400, and cenegermin showed the highest risk for ocular injuries.
- Blurred vision and visual impairment were the most common ocular injuries reported.
- Most drugs showed early-onset adverse effects, emphasizing the need for close monitoring at treatment initiation.

## Abstract

This study aimed to detect risk signals of drug-related ocular injuries, delineate their real-world epidemiological features, and provide evidence-based guidance for safe clinical use by utilizing the US Food and Drug Administration Adverse Event Reporting System (FAERS).

Adverse event reports classified under “Eye disorders” (System Organ Class, SOC) were extracted from the FAERS database covering Q1 2004 to Q4 2024. Disproportionality analyses were employed to identify drug-ocular injury associations, and the time-to-onset (TTO) of adverse reactions was analyzed using Weibull distribution modeling.

A total of 1,242,518 reports from 832,314 patients were included, with females accounting for 60.56% and elderly patients (≥65 years) for 21.63%. Serious outcomes comprised 62.80% of the reports. In total, 2,696 primary suspect drugs were identified, of which 359 met the signal detection criteria. High-risk drug categories included sensory organ drugs (ATC: S class, ROR = 4.93) and antineoplastic/immunomodulating agents (ATC: L class, most reports but ROR = 0.84). The top three drugs by signal strength were brolucizumab (ROR = 132.15), macrogol 400 (ROR = 117.96), and cenegermin (ROR = 60.19). The most common ocular injury types were blurred vision (121,517 cases), visual impairment (113,320 cases), and cataract (51,826 cases). TTO analysis indicated that most drugs exhibited an “early failure type” (β < 1), such as dupilumab (β = 0.68); only two drugs exhibited a random failure type.

The risk of drug-related ocular injuries is primarily associated with sensory organ drugs and biologics, with the greatest risk occurring during the early treatment phase. Clinical monitoring should prioritize female and elderly patients, especially regarding ocular symptoms at the onset of drug therapy, to strengthen pharmacovigilance and inform personalized medication.