Disproportionality analyses of acoltremon: a real-world safety assessment based on the the FDA adverse event...

Acoltremon is a first-in-class transient receptor potential melastatin 8 agonist approved for the treatment of the signs and symptoms of dry eye disease. Given its increasing clinical use following recent approval, post-marketing evaluation of its adverse event (AE) profile is warranted. This study aims to offer insights into the characteristics of acoltremon association with AEs.

Disproportionality analysis, including the reporting odds ratio, proportional reporting ratio, information component, and empirical Bayesian geometric mean, were employed in our study. AE signals are determined by using these algorithms. The database for analysis, sourced from the FDA Adverse Event Reporting System, covers the period from the second quarter of 2025 to the first quarter of 2026.

A total of 2,667 AEs associated with acoltremon were identified, with 45 positive signal preferred terms in our study. The three most frequently reported AEs during acoltremon treatment were eye irritation (n = 1,420), eye pain (n = 475) and ocular hyperaemia (n = 226), and the top three AE signals based on reporting odds ratio (ROR) values were eye irritation (380.62, 95% confidence interval (CI): 355.07-408.02), eye pain (129.42, 95% CI: 116.94-143.23) and abnormal sensation in eye (122.70, 95% CI: 78.77-191.14). Drug hypersensitivity (n = 45, ROR 4.15) was also identified as a disproportionality signal in this study. Notably, rhinorrhoea (n = 35, ROR 5.78), nasal discomfort (n = 5, ROR 12.37), ear pruritus (n = 4, ROR 8.09), ophthalmic herpes simplex (n = 3, ROR 57.73), respiratory tract infection viral (n = 3, ROR 8.12) were newly detected disproportionality signals identified. Comparative analysis with other dry eye therapies showed that several ocular AEs were also observed with comparator treatments, whereas some newly detected signals, including rhinorrhoea, nasal discomfort, ear pruritus and ophthalmic herpes simplex were not detected among the comparator drugs. Sensitivity analysis excluding reports with concomitant medications showed that the major disproportionality findings remained generally consistent, although several signals were no longer detected, including ear pruritus, ophthalmic herpes simplex, and respiratory tract infection viral.

This study identified potential safety signals associated with acoltremon in the FAERS database. These findings should be interpreted cautiously and warrant further pharmacovigilance and clinical investigation.