(C-182) Sight-threatening Eye Disorders in Patients Treated with Semaglutide : A Disproportionality Analysis Using the FAERS Database

Background: Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonists approved for managing blood glucose levels and weight loss, has raised concerns about its potential impact on vision.

Objectives: To evaluate the association between semaglutide use and sight-threatening adverse events (AEs) by conducting disproportionality analysis of the FDA Adverse Event Reporting System (FAERS) database.

Methods: A retrospective pharmacovigilance study was conducted using the FAERS database to extract cases of ophthalmic complications associated with semaglutide use, up to September 2024.. The primary outcome is to assess the risk associated with semaglutide use and sight-threatening AEs, while the secondary outcome involves evaluating other eye-related disorders. Disproportionality analysis was performed using both frequentist methods, including reporting odds ratio (ROR) and proportional reporting ratio (PRR), as well as bayesian-based methods, such as information component (IC025) and empirical bayesian geometric mean (EB05). Signal refinement was performed by restricting the drug role to primary suspect, and stratified analysis by age and gender assessed demographic variations.

Results: Analysis of FAERS data up to the fourth quarter of 2024 identified 1,547 sight threatening related events classified under 19 Preferred Terms (PTs). All 19 PTs related to semaglutide-induced ocular AEs showed statistically significant signal scores, with optic ischemic neuropathy (n = 86) demonstrated a strongest association (ROR: 17.00; 95% CI, 13.68-21.12; PRR: 16.96; 95% CI, 13.66-21.07; IC025 :1.81; EB05: 9.57) followed by diabetic eye disease (N = 6; ROR: 7.25; 95% CI, 3.23-16.28; PRR: 7.25 ; 95% CI, 3.23-16.27; IC025: 0.83; EB05:14.04), vitreous detachment, vitreous haemorrhage, vision blurred, retinal vascular occlusion and retinal detachment. The majority of PTs remained statistically significant after refinement, and stratification by age group showed higher prevalence of AEs in female sex and older age (65-85 years).

Conclusions: This study establishes a definitive association between semaglutide use and sight-threatening AEs. Further investigation and rigorous monitoring are necessary to elucidate the underlying pathophysiological mechanisms and validate these associations