Safety and efficacy results from two phase III trials, MIST-1 and MIST-2, for pharmacologic mydriasis (pupil dilation)

Eyenovia, Inc. announced the safety and efficacy results from the Company’s two Phase III trials, MIST-1 and MIST-2, for pharmacologic mydriasis (pupil dilation). The results were presented by David Wirta, M.D., from the podium during the joint American Society of Cataract and Refractive Surgery (ASCRS) and American Society of Ophthalmic Administrators (ASOA) Annual Meeting, in San Diego, CA.

The MIST-1 study enrolled 64 subjects, in whom both eyes were treated on separate days with MicroStat, Eyenovia's proprietary fixed combination, microdosed ophthalmic solution and with each component formulation (i.e. tropicamide and phenylephrine). The MIST-2 study enrolled 70 subjects, in whom both eyes were treated on separate days with MicroStat and a placebo solution. All treatments in the MIST-1 and MIST-2 trials were administered using Eyenovia’s Optejet dispenser that allows for dosing of approximately 8 microliters, which is less than 25% of the dose volume typically administered with eye dropper bottles.

In each trial, MicroStat was shown to be safe and effective for pharmacologic mydriasis achieving clinically and statistically superior mean pupil dilation. Collective results show approximately 94% of treated eyes achieved pupil dilation of at least 6mm at 35 minutes post-instillation. Dilation was rapid in most patients, with up to 64% of fixed-combination treated eyes achieving 6mm or greater dilation as early as 20 minutes post-installation. Adverse events were infrequent (~3% of subjects), transient, and generally mild in nature.

Dr. Wirta, principal investigator of the MIST-1 study, said, “We believe these outcomes further validate ocular microdosing and demonstrate that less can be more – less preservative and medication exposure still delivers a compelling ocular biologic effect while sparing the ocular surface from the toxicity associated with preservatives and some topical medications.”