Benzinga - The FDA approved Eyenovia Inc's (NASDAQ: EYEN) Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for inducing mydriasis for diagnostic procedures and in conditions where short-term pupil dilation is desired.
The approval marks the first product using Eyenovia's proprietary Optejet device to be approved by any regulatory authority.
Also Read: Eyenovia's Optejet Shows Lower Proinflammatory Cytokines Levels, Chemokines Than Standard Drops.
Mydcombi is designed to improve the efficiency of the estimated 106 million office-based comprehensive eye exams performed every year in the United States and the estimated 4 million pharmacologic mydriasis applications for cataract surgery.
The product is contraindicated and should not be used in patients with known hypersensitivity to any formulation component.
"We look forward to introducing Mydcombi to key offices beginning this summer while we bring our internal manufacturing capabilities online for 2024," stated Michael Rowe, CEO.
The approval comes with warnings, including significant elevations in blood pressure and rare central nervous system disturbances in pediatric patients.
The drug can also produce transient elevation of intraocular pressure and rebound miosis (excessive pupil shrinking) after one day of administration.
Price Action: EYEN shares are down 1.63% at $4.53 on the last check Monday.
© 2023 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.