Mydcombi Effective, Tolerable at Lowest Deliverable Dose for Mydriasis

Eyenovia has provided an update on the phase 4 study of tropicamide and phenylephrine hydrochloride ophthalmic spray (Mydcombi) 1%/2.5% for mydriasis.¹

Announced on April 25, 2024, the phase 4 study was designed to characterize the efficacy and duration of effect of the lowest deliverable dose for pupil dilation (8 µL per eye). The findings highlighted that approximately two-thirds of patients could achieve clinically relevant pupil dilation at 30 minutes post-dose.

“The results of this study highlight the favorable efficacy and tolerability of Mydcombi dispensed through the Optejet®. 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,” Michael Rowe, chief executive officer of Eyenovia, said in a statement.¹

Mydcombi was approved by the US Food and Drug Administration (FDA) in May 2023, representing the first approved fixed-dose combination of tropicamide and phenylephrine for inducing mydriasis for diagnostic procedures and short-term pupil dilation.² Its approval also marked the first product approved by any regulatory authority to use the company’s proprietary Optejet® device.

Previously, in October 2021, the company received a Complete Response Letter (CRL) from the FDA to their New Drug Application (NDA) for Mydcombi, requesting additional device testing related to the Optejet® dispenser.² The resubmitted NDA for MydCombi was accepted by the FDA in December 2022 and was supported by the completed phase 3 MIST-1 and MIST-2 clinical trials.²

For this phase 4 study, 29 individuals were treated with a half-dose of Mydcombi State University of New York School of Optometry and evaluated at the end of 2023. Results showed pupil dilation was achieved in 67% of patients at 30 minutes post-dose.

By the 60-minute mark, investigators found the percentage of pupil dilation increased to 86%. Most patients returned to a pupil size of <5mm between 3.5- and 6 hours post-instillation, with 93% meeting that point at the 6-hour mark. Safety data indicated the administration of a lower 8 µL volume was well-tolerated and minimal adverse events were reported.

Current mydriatic eye drops utilized in eye examinations are limited by several factors, including the potential for cross-contamination, difficulty instilling in those with limited mobility, and often, tolerability and safety issues.³ At higher levels, phenylephrine has been found to cause serious systemic cardiovascular side effects in older individuals, particularly those with high blood pressure.

The full data set highlighting the favorable efficacy and tolerability of Mydcombi is expected to be presented at an upcoming medical meeting this year, according to Eyenovia.¹

“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,” Rowe added.

References

1. _{Eyenovia provides clinical and scientific update on FDA-approved products MydcombiTM and Clobetasol Propionate Ophthalmic Suspension. Eyenovia Inc. April 25, 2024. Accessed April 25, 2024. https://ir.eyenovia.com/news-releases/news-release-details/eyenovia-provides-clinical-and-scientific-update-fda-approved.}
2. _{Iapoce C. FDA approves fixed-dose ophthalmic spray for Mydriasis. HCP Live. May 8, 2023. Accessed April 25, 2024. https://www.hcplive.com/view/fda-approves-fixed-dose-ophthalmic-spray-mydriasis.}
3. _{K Lodhi SA, Ramsali MV, Kulkarni DK, Surender P, Murty S. Safety of tropicamide and phenylephrine in pupillary mydriasis for cataract surgery. Saudi J Ophthalmol. 2022;35(2):108-111. Published 2022 Feb 18. doi:10.4103/1319-4534.337859}