Eyenovia announced that it has enrolled the first patient in the first of two phase 3 trials (MIST-1 and MIST-2) of the company’s MicroStat program for pharmacologic mydriasis. 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.
“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,” Dr. Sean Ianchulev, Eyenovia’s Chief Executive Officer and Chief Medical Officer, said in a company news release. “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 3 MicroStat program in the first half of 2019.”
The two phase 3 trials are randomized, double-blind, multicenter-superiority studies, which will each enroll approximately 65 participants in the United States. In the MIST-1 study, both eyes of the participants will be treated on separate days with Eyenovia’s proprietary fixed combination mydriatic solution and each of the component solutions. In the MIST-2 study, participants will receive Eyenovia’s fixed combination mydriatic solution and a placebo on separate days. All treatments will be administered using the Optejet dispenser. The primary endpoint for both studies is the mean change in baseline pupil diameter at 35 minutes after administration of study treatment.