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EYEN: Eyenovia Announces FDA Acceptance of the MydCombi NDA

EYEN
+0.51%
Tue, March 2, 2021, 6:30 AM


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EYEN
+0.51%
PDUFA Date Expected 4Q 2021

Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for MydCombi™, a unique fixed combination mydriatic (pupil dilation) agent for potential use in the over 80 million comprehensive eye exams currently conducted each year in the United States. If approved, MydCombi would be the first microdosed ocular therapeutic applied with a high precision smart delivery system, the Optejet®.

"We are excited to see MydCombi, with our proprietary microdose array print technology, move closer to potential approval, with an expected PDUFA date in the fourth quarter of this year. MydCombi may address many of the current shortfalls of pupil dilation, which according to market research may be responsible for millions of people choosing not to undergo a comprehensive eye exam," said Dr. Sean Ianchulev, Chief Executive Officer and Chief Medical Officer of Eyenovia. "If approved, we believe MydCombi would provide patients with one of the biggest advances in clinical mydriasis in the last few decades."

https://finance.yahoo.com/news/eyenovia-announces-fda-acceptance-mydcombi-123000760.html