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MicroStat meets primary endpoint in phase 3 study
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A second phase 3 clinical trial of Eyenovia’s MicroStat fixed-combination formulation showed positive results and met its primary endpoint, according to a press release.
The MIST-2 multicenter, randomized, double-masked, superiority trial included 70 subjects treated with the MicroStat fixed combination formulation of phenylephrine 2.5% and tropicamide 1% administered using Eyenovia’s piezo-print delivery Optejet dispenser. It was compared with placebo, which was also delivered via the Optejet dispenser.
The MicroStat group was clinically and statistically superior in terms of mydriatic effect compared with the placebo group at 35 minutes after administration; the difference in mean pupil dilation was 4.6 mm, the release said.
In addition, 93% of eyes in the treatment group had 6 mm or greater pupil dilation and 68% had 7 mm or greater pupil dilation at 35 minutes. The placebo group did not have 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, MPH, Eyenovia’s CEO and chief medical officer, said in the 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.”