Pharma Focus Asia

Eyenovia Announces FDA Approval of Mydcombi™

Tuesday, May 09, 2023

Eyenovia 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.

Mydcombi is designed to improve the efficiency of the estimated 106 million office-based comprehensive eye exams performed every year in the United States, as well as 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 component of the formulation.

The FDA approval of Mydcombi provides critical validation of the Optejet as it is the first product approved using the Optejet platform, which is core not only to internal development programmes, including MicroLine for presbyopia, but also for partnered programmes. It unlocks significant opportunities in the future treatment of other ophthalmic conditions including glaucoma and dry eye.
 

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