Eyenovia (NSDQ:EYEN) said this week that it finished patient enrollment in its Phase III Mist-1 trial and enrolled the first patient in its second Phase III trial for the company’s combination eye solution delivered as a micro-dose using its Optejet device.
The company is studying the therapy for pharmacologic mydriasis – pupil dilation for eye exams. The process is used in roughly 80 million office-based eye exams each year in the U.S., according to Eyenovia.
The two Phase III trials are designed to enroll 65 participants. In the Mist-1 study, both eyes of the participants will be treated separate days with Eyenovia’s therapy and each of the component solutions. In the Mist-2 trial, participants will be treated with Eyenovia’s therapy and a placebo on separate days. All therapies will be delivered using Eyenovia’s Optejet device.
For both trials, the primary endpoint is the mean change in baseline pupil diameter at 35 minutes following administration of treatment.
“We are pleased to have swiftly completed enrollment in the Phase III 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,” CEO & CMO Dr. Sean Ianchulev said in prepared remarks. 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.”
Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.