Eyenovia Submits New Drug Application to FDA for Pharmacologic Mydriasis with MydCombi Targeting 80 Million Patient Encounters in the U.S. Annually - Seite 2

The NDA submission was based on the MIST-1 and MIST-2 studies. In these two Phase 3 studies, a fixed combination of micro-dosed phenylephrine 2.5% and tropicamide 1% ophthalmic solution was shown to be safe and effective for pharmacologic mydriasis. Approximately 94% of treated eyes achieved 6mm or greater dilation at 35 minutes post-instillation. All adverse events were infrequent at 3.1%; fewer than 1% of patients reported blurred vision, reduced acuity, photophobia or instillation site pain.

“Pupil dilation is a necessity for most eye exams. The process today can add several minutes to each exam, which over the course of the day often translates to fewer patients examined. MydCombi has the potential to significantly improve patient flow and make the in-office mydriasis process more efficient and more comfortable for patients,” said Dr. James Tsai, president of New York Eye and Ear Infirmary of Mount Sinai and a member of the Eyenovia Scientific Advisory Board.

About Eyenovia, Inc.

Eyenovia, Inc. (NASDAQ: EYEN) is a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP) therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for presbyopia, myopia progression and mydriasis. For more Information, visit www.eyenovia.com.

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