FDA approves Mydcombi for inducing mydriasis for diagnostic eye procedures.-Eyenovia Inc.
Eyenovia Inc. announced the FDA approval of 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.
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 validation of the Optejet as it is the first product approved using the Optejet platform, which is core not only to Eyenovia’s internal development programs, including MicroLine for presbyopia, but its partnered programs as well.
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