Eyenovia planning NDA in 1Q20 for microdose ophthalmic solution to induce mydriasis

Eyenovia Inc. (NASDAQ:EYEN) plans to submit an NDA to FDA in 1Q20 for MicroStat to induce mydriasis (dilation of the pupil) after the product met the primary endpoint in the Phase III MIST-1 trial. MicroStat is a fixed-microdose ophthalmic solution of 2.5% phenylephrine and 1% tropicamide delivered using the company's OpteJet system.

On the double-blind, U.S. trial's primary endpoint of mean pupil dilation at 35 minutes after the initial dose, Eyenovia said MicroStat showed "a statistically and clinically superior mydriatic effect" compared with either component of MicroStat alone among 64 patients...