Benzinga | Mar 2, 2021 07:41AM EST

Eyenovia Announces FDA Acceptance of the MydCombi NDA

Eyenovia, Inc. (NASDAQ:EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP(tm)) therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for MydCombi(tm), 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(r).

"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."

Approximately 90% of eye care providers reported that they encounter situations where patients avoid pharmaceutical pupil dilation often due to discomfort with the procedure, according to market research conducted by J. Reckner Associates.

MydCombi was developed with the goal of providing a touchless fixed combination microdose formulation to improve the patient's clinical experience. MydCombi is delivered by Eyenovia's proprietary Optejet dispenser, designed to ensure consistent and easy application of two mydriatic medications in a quick, touchless micro-mist application. The Optejet is also designed with no protruding parts, which may help prevent accidental touching of the ocular surface.

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 tropicamide 1% and phenylephrine 2.5% ophthalmic solution met the studies' primary endpoints and 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. Adverse events were infrequent, with fewer than 1% of patients reporting blurred vision, reduced acuity, photophobia or instillation site pain.