The Mist-1 and Mist-2 trials are slated to study the safety and efficacy of the company’s 2.5% phenylephrine, 1% tropicamide eye solution, delivered as a micro-dose using the Optejet device.
The company is assessing its combination therapy for pharmacologic mydriasis – pupil dilation for eye exams. Eyenovia said the process is used in roughly 80 million office-based eye exams each year in the U.S.
Both Phase III trials are designed to enroll 65 people. In the Mist-1 trial, both eyes of the participants will be treated on different days with Eyenovia’s treatment and each of the component solutions.
In the Mist-2 trial, participants will be treated with Eyenovia’s product and a placebo on different days. All doses will be given using Eyenovia’s Optejet dispenser.
For both studies, the primary endpoint is the mean change in baseline pupil diameter at 35 minutes following administration of the treatment.
“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,” CEO & CMO Dr. Sean Ianchulev said in prepared remarks. “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.”
EYEN shares were trading at $3.01 apiece in afternoon activity today, up +15.8%.