Drug/Device Combo gets FDA Approval for Eye Dilation

The FDA has approved Eyenovia’s Mydcombi — a drug/device combination ophthalmic spray using the company’s Optejet device — for dilation of the pupil.

Mydcombi is approved for visual acuity eye exams for as well as diagnostic and treatment procedures such as cataract surgery.

The device is the first approved fixed dose combination of tropicamide and phenylephrine in the U.S., the company said, hoping the device will improve the efficiency of an estimated 106 million annual office-based eye exams performed in the U.S., as well as the estimated 4 million applications for cataract surgery.

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