NEW YORK, Feb. 21, 2018 (GLOBE NEWSWIRE) -- Eyenovia Inc. (“Eyenovia”), (NASDAQ:EYEN), a clinical stage biopharmaceutical company developing a pipeline of ophthalmology products utilizing its patented piezo-print technology to deliver micro-therapeutics topically to the eye, today announced that following discussions with the U.S. Food and Drug Administration (FDA), it has received clear feedback on its pivotal trial protocol design, as well as confirmation to advance its MicroPine therapeutic program for the treatment of progressive myopia into Phase III clinical development. Based on the growing clinical evidence from academic and collaborative trials, Eyenovia has received feedback that only one Phase III pivotal study will be required for registration instead of two trials. The MicroPine Phase III trial for myopia is planned to start in the first half of 2019.



MicroPine is Eyenovia’s proprietary micro-therapeutic formulation of atropine to slow the progression of myopia (nearsightedness). Progressive moderate-to-severe myopia is associated with significant ocular morbidity, including increased rate of retinal detachment, choroidal and retinal atrophy, choroidal neovascularization, all of which can lead to irreversible vision loss. Myopia develops in childhood and is very common in adults. It is estimated that more than 80 million children worldwide and more than 5 million children in the U.S. have myopia. Currently, there is no FDA approved therapy to treat the progression of refractive myopia.

To advise the company on the myopia program, Eyenovia has appointed accomplished pediatric ophthalmologist Douglas Fredrick, M.D., Clinical Professor of Ophthalmology and Pediatrics at Lucile Packard Children’s Hospital at Stanford, to its Scientific Advisory Board and Myopia Program Steering Committee.

“Eyenovia recently published the results of its second Phase II trial validating the strong biologic and pharmacodynamic effect of its piezo-print microformulation approach, designed to improve the therapeutic index of many front-of-the-eye treatments,” commented Dr. Fredrick. “This is a particularly exciting time to join Eyenovia as we further evaluate the company’s high-precision micro-dosing delivery system to better manage and treat pediatric patients suffering from myopia, for which there remains a significant unmet need due to associated co-morbidities. I look forward to working with the team and guiding the company based on the positive feedback from the FDA to advance the MicroPine program to initiation of the Phase III trial.”

Dr. Sean Ianchulev, Eyenovia’s Chief Executive Officer added, “With deep ophthalmology experience, particularly in myopia prevention and pediatric cataracts, Dr. Fredrick brings invaluable expertise to Eyenovia. Along with Dr. Pamela Gallin, Professor of Pediatric Ophthalmology, Columbia University, the pediatric steering committee of our Scientific Advisory Board has some of the top physicians in the field, which will enable us to better navigate the development opportunities ahead. We look forward to working with these experts to further develop our micro-dose delivery technology, which has great potential to transform the therapeutic paradigm for front-of-the-eye diseases.”

Dr. Fredrick is a Clinical Professor and board-certified ophthalmologist specializing in pediatric ophthalmology and brings more than 30 years of experience at leading medical institutions. He serves as the Director of Residency Program, Vice Chair of Education and Vice Chair of Clinical Affairs at the Stanford University School of Medicine Byers Eye Institute. Prior to joining Stanford University, he was a full-time faculty member at the University of California San Francisco and Dartmouth. Dr. Fredrick is a member of the American Academy of Ophthalmology, American Academy of Pediatrics and the American Association of Pediatric Ophthalmology and Strabismus (AAPOS). He completed his ophthalmology residency at the University of California San Francisco and fellowship in pediatric ophthalmology at Boston Children’s Hospital. Dr. Fredrick has authored more than 30 publications and serves as an Invited Reviewer for Ophthalmology, The British Journal of Ophthalmology and the Journal of American Association for Pediatric Ophthalmology and Strabismus.

About Eyenovia

Eyenovia is a specialty biopharmaceutical company building a portfolio of next generation topical eye treatments based on its proprietary delivery and formulation platform for micro-therapeutics. Eyenovia’s pipeline is currently focused on the late-stage development of micro-therapeutics for glaucoma and other eye diseases.

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Eyenovia Inc.

John Gandolfo

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