Eyenovia announced that it has completed patient enrollment in its phase 3 MIST-1 study and enrolled the first patient in its second phase 3 study, the MIST-2 trial, for the company’s phase 3 MicroStat program for pharmacologic mydriasis.
“We are pleased to have swiftly completed enrollment in the phase 3 MIST-1 study, our first pivotal trial of MicroStat for pharmacologic mydriasis, in line with our recruitment expectations. In rapid succession we have also enrolled the first patient in MIST-2, the second pivotal trial in the MicroStat program,” Sean Ianchulev, MD, MPH, Eyenovia’s Chief Executive Officer and Chief Medical Officer, said in a company news release. “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 remains essential for the standard dilated retinal fundoscopic examination. We are confident that our micro-dosed fixed-combination of phenylephrine and tropicamide holds the potential to initiate a pivotal shift in how drugs are delivered to the eye and we look forward to announcing topline results from both trials in the first half of 2019.”
The MIST 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.
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.