Eyenovia announced that the FDA has accepted the company’s investigational new drug (IND) application to initiate phase 3 trials of MicroStat for diagnostic mydriasis.
MicroStat is a first in class fixed-combination of phenylephrine and tropicamide for in office mydriasis, a standard part of the approximately 80 million comprehensive exams performed every year in the United States. In an earlier published phase 2 study, MicroStat, in combination with the Optejet dispenser, demonstrated consistent micro-dose delivery while also achieving therapeutic levels necessary for pupil dilation. With the acceptance of the IND, Eyenovia expects to initiate the phase 3 trials of MicroStat later this month.
“We are very pleased to have received acceptance of our IND application for MicroStat from the FDA and are very excited to officially become a phase 3 company,” Dr. Sean Ianchulev, Eyenovia’s Chief Executive Officer and Chief Medical Officer, said in a company news release. “As our first clinical program to enter phase 3 trials, the MicroStat program could provide important validation of our entire platform delivery technology. We look forward to initiating the trials in late November and expect to report topline results in the first half of 2019.”