Studies Demonstrate the Efficacy and Safety of Eyenovia MAP Fixed-Combination Tropicamide-Phenylephrine Product for Mydriasis
Eyenovia announced the publication of “Mydriasis with micro-array print touch-free tropicamide-phenylephrine fixed combination MIST: pooled randomized Phase III trials” in Therapeutic Delivery.
The publication features pooled results from two prospective, double-masked, controlled, cross-over superiority phase 3 studies that concluded a micro-dosed fixed-combination of tropicamide 1% and phenylephrine 2.5% for pupil dilation (mydriasis) is safe and effective and produced clinically relevant and statistically superior pupil dilation compared with either agent alone and placebo.
Approximately 93% of eyes treated with tropicamide-phenylephrine achieved 6 mm or greater dilation at 35 minutes post-dose as compared to 78% with tropicamide and 2% with phenylephrine. Additionally, the proportion of fully non-responsive pupils at 35 minutes post-dose was 98% with tropicamide-phenylephrine compared with 76% and 5%, respectively, with tropicamide and phenylephrine alone. Adverse events with tropicamide-phenylephrine were infrequent at 3% and mild with fewer than 1% of patients reporting blurred vision, reduced acuity, photophobia or instillation site pain. The pooled analysis included 131 subjects and all treatment arms used Eyenovia’s proprietary Optejet, a first-of-its-kind dispenser designed for high precision targeted administration, delivering approximately 80% less medication and preservatives to patients than eyedroppers and potentially improving local tolerability.
“Pupil dilation has a deserved reputation for being a cumbersome, time consuming and often uncomfortable part of eye exams, which is why many patients dislike and sometimes forego it,” David Wirta, MD, Medical Director of the Eye Research Foundation in Newport Beach, California, and investigator of a MIST study, said in a company news release. “The advent of a combination agent for pupil dilation that can bring patients greater clinical benefits than existing medicines and delivers medication in a novel, less taxing way has the potential to improve our nation’s eye health, hopefully moving more people to have a comprehensive eye exam.”
This publication follows the FDA’s recent acceptance of Eyenovia’s new drug application (NDA) for MydCombi, the micro-dosed fixed-combination tropicamide-phenylephrine agent evaluated in these pivotal studies. The expected PDUFA date for the potential approval of MydCombi is in the fourth quarter of 2021.
“This publication further validates that microdosed tropicamide-phenylephrine with our proprietary and novel Optejet dispenser has many advantages that could make pupil dilation easier, more comfortable and safer. The Optejet may reduce the risk of cross-contamination because unlike an eyedropper bottle, the Optejet has no protruding parts. The MAP drug delivery may also enable anesthetic-free dilation and streamlines care, making the process more efficient,” Beth Scott, OD, Team Leader and Head of Medical Affairs at Eyenovia, said in the news release. “These results highlight the potential advantages of our Optejet dispenser to effectively and safely deliver advanced therapies, with the ability to be applied to additional medications and indications.”
MydCombi was developed to address several challenges eye care practitioners and their patients face related to pupil dilation, a procedure conducted during most of the estimated 80 million office-based comprehensive and diabetic eye exams performed in the U.S. annually. The current standard of care for pupil dilation requires multiple eye drops including a topical anesthetic, given at least several minutes apart, which can take considerable time and often cause both discomfort and drug overflow. The design of eyedroppers also lends itself to the possibility of inadvertent contact with the eye itself, which may be an issue, as the same eyedropper bottle is often shared among a number of patients. In contrast, MydCombi is delivered by Eyenovia’s proprietary Optejet dispenser, designed to ensure consistent and easy application of two mydriatic medications in a quick, touchless micro-mist application. The product is designed with no protruding parts, which may help prevent accidental touching of the ocular surface.