Eyenovia, Inc. announced the FDA approval of Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1% / 2.5% for inducing mydriasis.
Tell me more about Mydcombi.
The ophthalmic spray consists of a proprietary, first-in-class, fixed-dose combo product of tropicamide and phenylephrine and has been designed to induce mydriasis during in-office diagnostic procedures and conditions that call for short-term pupil dilation
It was developed as a micro-formulation to be used sans anesthetic and administered with the Optejet device platform.
Refresh me on this Optejet tech.
Designed for ocular therapeutics, the Optejet device uses Eyenovia’s Microdose Array Print (MAP) technology as a topical delivery system, similar to an inkjet printer.
Medication is dispensed horizontally in a mist, coating the surface of the cornea. Of note, contact to the eye occurs at a low velocity in order to reduce ocular impact.
Any clinical data to back the approval up?
Two completed phase 3 trials—MIST-1 (NCT03751631) and MIST-2 (NCT03751098) —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 device.
Significance?
This approval is the first for a fixed-dose combination of tropicamide and phenylephrine in the United
States.
On top of that, MydCombi is also the first product featuring Eyenovia’s Optejet device technology to be approved by any regulatory authority.
When will it be available?
According to CEO Michael Rowe, Eyenovia is looking to introduce MydCombi to key offices beginning this summer while the company focuses on bringing its internal manufacturing capabilities online for 2024.