Eyenovia announces fda approval of mydcombi™, the first ophthalmic spray for mydriasis, which also leverages the company's proprietary optejet® device platform
Represents the first fda approved fixed-combination of tropicamide and phenylephrine for mydriasis provides critical validation of key technology that is core to eyenovia's proprietary development programs as well as current and future partnerships new york, may 08, 2023 (globe newswire) -- eyenovia, inc. (nasdaq: eyen), an ophthalmic technology company developing the optejet® device for use both in connection with its own drug-device therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced that the u.s. food and drug administration (fda) has approved 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. this represents the first approved fixed dose combination of tropicamide and phenylephrine in the united states and also the first product using eyenovia's proprietary optejet device to be approved by any regulatory authority.
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