Eyenovia provides clinical, scientific update on products Mydcombi, Clobetasol

Eyenovia provided an update on its two FDA-approved products. Phase IV study of Mydcombi 1%/2.5%: Eyenovia announced results from a Phase IV study of Mydcombi designed to characterize the lowest deliverable dose for mydriasis. Mydcombi is the only FDA-approved fixed dose combination of tropicamide and phenylephrine hydrochloride ophthalmic spray 1%/2.5%, and the first FDA-approved product in the Optejet. This Phase IV study was designed to determine the efficacy and duration of effect of the lowest deliverable dose of Mydcombi for pupil dilation. Study highlights: At 30 minutes post dose, clinically relevant pupil dilation was achieved in approximately 67% of patients; By 60 minutes, that percentage increased to 86%; The majority of patients returned to a pupil size of less than 5mm between 3.5 and 6 hours post-instillation, with 93% reaching that point by 6 hours; Administering a lower 8 microliter volume was well tolerated with minimal adverse events reported. ARVO Presentation: Eyenovia also announced that the company will deliver a presentation at the Association for Research in Vision and Ophthalmology 2024 Annual Meeting, which is being held May 5-9, 2024, in Seattle, WA. The presentation will detail results from a study demonstrating that Formosa Pharmaceuticals’ Active Pharmaceutical ingredient Nanoparticle Technology can improve solubility and bioavailability of topical ophthalmic medications. Eyenovia licensed clobetasol propionate ophthalmic suspension 0.05%, which leverages APNT technology, from Formosa in August 2023, and clobetasol was subsequently approved by the U.S. Food and Drug Administration for the treatment of post-operative inflammation and pain in March 2024.