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Eyenovia Announces FDA Acceptance of MicroStat IND Application for Mydriasis
Company on track to initiate Phase III trials in late November
NEW YORK, Nov. 13, 2018 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a biopharmaceutical company developing a pipeline of ophthalmology products utilizing its patented piezo-print technology to deliver micro-dosed medications topically to the eye, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug (IND) application to initiate Phase III trials of MicroStat for diagnostic mydriasis.
MicroStat is a first in class fixed-combination of phenylephrine and tropicamide for in office mydriasis (pupil dilation), a standard part of the approximately 80 million comprehensive exams performed every year in the United States. In an earlier published Phase II study, MicroStat, in combination with the Optejet™ dispenser, demonstrated consistent micro-dose delivery while also achieving therapeutic levels necessary for pupil dilation. With the acceptance of the IND, Eyenovia expects to initiate the Phase III trials of MicroStat later this month.
“We are very pleased to have received acceptance of our IND application for MicroStat from the FDA and are very excited to officially become a Phase III company,” commented Dr. Sean Ianchulev, Eyenovia’s Chief Executive Officer and Chief Medical Officer. “As our first clinical program to enter Phase III trials, the MicroStat program could provide important validation of our entire platform delivery technology. We look forward to initiating the trials in late November and expect to report topline results in the first half of 2019.”
Eyenovia, Inc. (NASDAQ: EYEN) is a specialty biopharmaceutical company building a portfolio of next generation topical eye treatments based on its proprietary delivery and formulation platform for microdosing. Eyenovia’s pipeline is currently focused on the late-stage development of microdosed medications for myopia progression, glaucoma, mydriasis and other eye diseases.
Forward Looking Statements
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Chief Financial Officer
The Ruth Group