Eyenovia shares surge on optimistic late-stage MicroStat trial

Shares of Eyenovia Inc (NASDAQ:EYEN) soared Wednesday after the biopharma company unveiled positive data from a late-stage trial evaluating the pupil-dilating ability of its MicroStat eye therapy.

The Phase 3 Mist-1 study evaluated the MicroStat combination therapy, which consists of 2.5% phenylephrine and 1% tropicamide, against tropicamide and phenylephrine respectively. Sixty-four subjects took part in the US-based trial and the treatments were delivered using Eyenovia’s OpteJet device.

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The trial met the primary endpoint of mean pupil dilation 35 minutes after the combination drug was administered. Of the patients receiving MicroStat, 94% of their eyes achieved 6 mm or greater in pupil dilation after 35 minutes. This compares with 78% and 1.6% for the tripicamide-only and phenylephrine-only groups.

After 20 minutes, 57% of the MicroStat-treated eyes achieved 6 mm pupil dilation or greater versus 38% of the tropicamide-treated eyes and none in the phenylephrine-treated eyes.

Investors were impressed by the results, sending Eyenovia shares up 29.3% to $3.40 in morning trade on Wednesday.

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The treatment is expected to improve the method of pupil dilation required as part of routine eye exams.

“We believe this is the first time in a Phase 3 FDA registration program that drugs have been delivered to the ocular surface using a smart microdose eyedropper-free delivery system – a meaningful step forward as we try to modernize the legacy eyedropper paradigm,” said Dr Sean Ianchulev, Eyenovia’s CEO and chief medical officer, in a statement. 

The New York-based company said it would look to present detailed results from the study in an upcoming scientific forum. Topline data from Eyenovia’s Mist 2 study is also expected soon.

Eyenovia’s pipeline is currently focused on the late-stage development of drugs for mydriasis, glaucoma, and other eye diseases.

Contact Ellen Kelleher at [email protected]

Story by ProactiveInvestors