Eyenovia (Nasdaq:EYEN) announced today that the FDA approved its Mydcombi treatment for use with the Optejet delivery device.
New York-based Eyenovia designed 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. It marks the first approved fixed-dose combination of tropicamide and phenylephrine in the U.S.
Eyenovia said it also represents the first product using Eyenovia’s proprietary Optejet device to receive any regulatory approval.
The company aims for Mydcombi to improve the efficiency of office-based, comprehensive eye exams. It’s contraindicated and should not be used in patients with known hypersensitivity to any component of the formulation.
Michael Rowe, CEO of Eyenovia, said this approval provides “critical validation” of Optejet. The device remains core to the company’s internal development programs, he said, as well as partnered programs. It aims to address conditions like glaucoma and dry eye with this platform in the future.
“The approval of Mydcombi, our first FDA-approved product, represents the culmination of years of tireless effort by the entire Eyenovia team, and I would like to express my sincere gratitude to the associates and technical experts who helped advance this important program through this transformational milestone,” said Michael Rowe, CEO of Eyenovia. “We look forward to introducing Mydcombi to key offices beginning this summer while we bring our internal manufacturing capabilities online for 2024.”