Eyenovia Announces Confirmatory Results from Second MicroStat Phase 3 Registration Study for Mydriasis

Eyenovia announced positive results from its second MicroStat phase 3 study, MIST-2, which examined the safety and efficacy of the company’s first-in-class MicroStat fixed-combination formulation for pharmacologic mydriasis.

The MIST-2 study was a US-based, multicenter, randomized, double-masked, superiority trial that enrolled 70 subjects, in whom both eyes were treated on separate days with Eyenovia’s proprietary MicroStat fixed combination formulation of phenylephrine 2.5% and tropicamide 1%. MicroStat was compared against a placebo solution, both of which were administered 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. 

“The MIST-2 study outcomes are consistent with those from our first MicroStat phase 3 study, MIST-1, in which the safety and efficacy of MicroStat was compared to its individual product components of phenylephrine 2.5% and tropicamide 1%,” Sean Ianchulev, MD, Eyenovia’s Chief Executive Officer and Chief Medical Officer, said in a company news release. “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.”

William Flynn, MD, principal investigator of the MIST-2 study added, “These 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 the detailed results from the MIST-2 trial at the American Academy of Cataract and Retinal Surgery (ASCRS) meeting in May 2019.