Eyenovia Initiates Phase III MicroStat Program for Pharmacologic Mydriasis: Enrolls First Patient in MIST-1 Study

Eyenovia (NASDAQ:EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose therapeutics utilizing its patented piezo-print technology, announced that it has enrolled the first patient in the first of two Phase III trials (MIST-1 and MIST-2) of the Company’s MicroStat program for pharmacologic mydriasis, or dilation of the pupil for an eye exam.

As quoted in the press release:

The studies will investigate the safety and efficacy of the Company’s first-in-class fixed-combination phenylephrine 2.5% – tropicamide 1% ophthalmic solution, administered as a micro-dose using the Optejet™ dispenser. Pharmacologic mydriasis is an important part of an estimated 80 million office-based comprehensive and diabetic eye exams performed each year in the United States and is essential for the standard dilated retinal fundoscopic examination.

“With the enrollment of the first patient in the first pivotal trial of MicroStat for pharmacologic mydriasis, Eyenovia officially transitions into a Phase III company,” commented Dr. Sean Ianchulev, Eyenovia’s Chief Executive Officer and Chief Medical Officer. “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. We look forward to announcing topline results from both trials in our Phase III MicroStat program in the first half of 2019.”

Click here to read the full press release.