Results from phase IV study of Mydcombi (phenylephrine + tropicamide) to characterize the lowest deliverable dose for mydriasis – Eyenovia

Eyenovia announced results from a Phase IV study of Mydcombi designed to characterize the lowest deliverable dose for mydriasis (pupil dilation). 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.

Current mydriatic eye drops used during eye exams have several limitations, including potential cross-contamination, difficulty instilling in patients with limited mobility, and in some patients, tolerability and safety issues. Phenylephrine, in higher amounts, has been known to cause serious potential systemic cardiovascular side effects in older patients, particularly those with high blood pressure.

This Phase IV study was designed to determine the efficacy and duration of effect of the lowest deliverable dose of Mydcombi for pupil dilation. Twenty-nine subjects were treated with a half dose of Mydcombi (8µL per eye) and evaluated at the end of 2023 at the State University of New York School of Optometry by Dr. Denise Pensyl, OD.

Study highlights : i. At 30 minutes post dose, clinically relevant pupil dilation was achieved in approximately 67% of patients; ii. By 60 minutes, that percentage increased to 86%; iii 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; iv. Administering a lower 8 microliter volume was well tolerated with minimal adverse events reported.

“The results of this study highlight the favorable efficacy and tolerability of Mydcombi dispensed through the Optejet,” stated Michael Rowe, Eyenovia’s Chief Executive Officer. “Notably, dilation was already dissipating by 3.5 hours post-instillation, which is similar to published studies of dilating eye drops followed by the use of a mydriasis reversal agent. These results suggest that for patients in which the lowest deliverable dose of tropicamide and phenylephrine may be desired, the precision and flexibility of the Optejet technology may be an option for eye care professionals and their patients.”