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First patient enrolled in phase 3 MicroStat program

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Eyenovia has enrolled the first patient in its phase 3 MicroStat program for pharmacologic mydriasis, according to a press release.

A fixed combination of phenylephrine 2.5% and tropicamide 1% ophthalmic solution will be administered as a micro-dose using the Optejet dispenser, the release said.

The randomized, double-masked, multicenter superiority MIST-1 and MIST-2 studies, each including approximately 65 participants, will investigate the safety and efficacy of the ophthalmic solution. In both studies, the primary endpoint is mean change in baseline pupil diameter 35 minutes after administration of the solution.

“We believe that our fixed combination of phenylephrine and tropicamide has the potential to significantly improve both the patient experience and physician workflow during eye exams,” Sean Ianchulev, MD, MPH, Eyenovia CEO and chief medical officer, said in the release.

Results from both trials are expected in the first half of 2019.