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Biotech Stocks Facing FDA Decision In October 2021

Eyenovia
Eyenovia

Eyenovia Inc.’s (EYEN) MydCombi, proposed for the treatment of mydriasis, awaits the FDA decision on October 28, 2021.

MydCombi is a fixed combination mydriatic (pupil dilation) agent, delivered by Eyenovia’s proprietary Optejet dispenser. This dispenser is designed to ensure consistent and easy application of two mydriatic medications in a quick, touchless micro-mist application.

Pupil dilation is conducted during most of the estimated 100 million office-based comprehensive and diabetic eye exams performed in the U.S. annually. The current standard of care for pupil dilation requires multiple eye drops given at least several minutes apart, which can take considerable time and often cause both discomfort and drug overflow.

If approved, MydCombi would be the first microdosed ocular therapeutic with a high precision smart delivery system.

The company sees a market opportunity of over $250 million annually for MydCombi.

EYEN closed Wednesday’s trading at $4.90, down 0.41%.