Eyenovia (NASDAQ:EYEN) reported positive results from its second Phase 3 study, MIST-2, evaluating the safety and efficacy of its MicroStat fixed-combination formulation for the treatment of pharmacologic mydriasis, or eye dilation.
The MIST-2 superiority study enrolled 70 subjects. They had both eyes treated on separate days with either Eyenovia’s proprietary MicroStat fixed combination formulation of phenylephrine 2.5% and tropicamide 1% or a placebo solution, using Eyenovia’s Optejet dispenser.
For the primary efficacy outcome of mean pupil dilation at 35 minutes post-administration, MicroStat was clinically and statistically superior to placebo in terms of mydriatic effect, with a treatment group difference of 4.6 mm.
Additional outcomes demonstrated that in the MicroStat group, 93% of eyes achieved 6 mm or greater pupil dilation and 68% of eyes achieved 7 mm or more pupil dilation at 35 minutes post-administration. None of the eyes in the placebo group achieved similar results.
Dr. Sean Ianchulev, CEO and CMO of Eyenovia, said the MIST-2 study outcomes were consistent with those from the first MicroStat Phase 3 study, MIST-1. “We are pleased to see that the outcomes of these two Phase 3 studies continue to validate the bioavailability and efficacy of microdose drug administration to the ocular surface using Eyenovia’s Optejet dispenser.”
Dr. William Flynn, principal investigator of the MIST-2 study, said the results confirm that a novel fixed combination of the two mydriatic agents, currently used individually, can provide a real benefit to eye care practitioners. “I look forward to when this combination becomes available, as it has the potential to positively impact the efficiency of my practice and the satisfaction of my patients.”
Eyenovia expects to present detailed results from the MIST-2 trial at the American Academy of Cataract and Retinal Surgery meeting in May 2019.
