Published in Pipeline

FDA accepts Eyenovia’s NDA for MydCombi for in-office mydriasis

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2 min read

The FDA has accepted Eyenovia’s new drug application (NDA) for MydCombi ophthalmic spray to treat in-office pupil dilation (mydriasis).

Tell me more about MydCombi.

The ophthalmic spray is made of Eyenovia’s proprietary, first-in-class, and fixed-dose combo product of tropicamide 1% and phenylephrine 2.5%. It was developed as micro-formulation to be used without anesthetic and administered via the company’s investigational Optejet drug delivery technology. (via)

How did it perform in clinical trials?

The MIST-1 (NCT03751631) and MIST-2 (NCT03751098) phase 3 trials assessed MydCombi in three ways: MIST-1 compared it to phenylephrine alone and tropicamide; MIST-2 compared it to a placebo. Treatments in both trials were conducted via the Optejet technology.

What’s the significance of this?

If FDA approved, MydCombi would be the first commercial product to use Eyenovia’s Optejet technology. Additionally, the product might improve efficiency for comprehensive eye examinations and cataract surgery that require pharmacologic mydriasis.

Anything else?

MydCombi is already licensed to Arctic Vision, a Hong Kong-based biotechnology start-up,  in Greater China and South Korea.

What’s next?

A Prescription Drug User Fee Act (PDUFA) target action date has been set for May 8, 2023. However, the FDA currently has no plans to hold an advisory committee meeting for the application.