Early-phase study evaluates AGN-241622 for presbyopia
AGN-241622 ophthalmic solution was well tolerated in healthy and presbyopic adults and showed modest improvements in near vision, according to results of a Phase 1/2 study.
The randomized, vehicle-controlled, participant- and investigator-masked study enrolled adults aged 40 to 65 years to receive AGN-241622 at concentrations of 0.01%, 0.03%, or 0.1%, or vehicle.
In Stage 1, treatments were administered once in the left eye, while Stage 2a involved daily bilateral dosing for 14 days.
Among 80 randomized participants, 76 completed the study. All treatment-emergent adverse events (TEAEs) were mild in severity, and all but one resolved; the unresolved event was not related to AGN-241622. Increased lacrimation was the most commonly reported ocular TEAE in Stage 1. In Stage 2a, 2 mild cases of dermatitis occurred in a single participant receiving AGN-241622 0.1%, leading to discontinuation; both events resolved and were deemed unrelated to treatment.
The study also reported modest reductions in pupil diameter and improvements in near visual acuity. Overall, AGN-241622 ophthalmic solution was well tolerated, with modest efficacy observed in binocular distance-corrected near visual acuity among presbyopic participants at the concentrations evaluated.
Reference
El-Harazi SM, Peace JH, Nguyen A, et al. Safety and Efficacy of AGN-241622 for Presbyopia: Results From a First-in-Human, Phase 1/2, Randomized, Vehicle-Controlled Study. J Ocul Pharmacol Ther. 2025;doi: 10.1177/10807683251396381. Epub ahead of print. PMID: 41248919.
