Eyenovia Announces FDA Acceptance of New Drug Application for MydCombi for In-Office Pupil Dilation
Eyenovia announced that the FDA has accepted for review the company’s new drug application (NDA) for MydCombi ophthalmic spray. MydCombi is a drug-device combination product that comprises the company’s proprietary, first-in-class combination of tropicamide and phenylephrine for in-office pupil dilation (mydriasis), administered via the investigational Optejet drug delivery technology.
The agency has assigned the resubmitted NDA a standard review with a Prescription Drug User Fee Act (PDUFA) target action date of May 8, 2023. The FDA also indicated that it is currently not planning to hold an advisory committee meeting to discuss the application.
“Acknowledgement of our MydCombi NDA is a significant step forward in our quest to bring a paradigm change in the way that topical eye drugs are developed and delivered, and we look forward to working with FDA during its review,” Michael Rowe, Chief Executive Officer of Eyenovia, said in a company news release. “If approved, MydCombi would be the first commercial product to leverage our proprietary Optejet drug delivery device, which we believe could bode well not only for our other internal development programs for presbyopia and progressive myopia but our ongoing partnering discussions as well.”
The MydCombi NDA is supported by two completed phase 3 clinical trials, MIST-1 and MIST-2. The MIST-1 trial (NCT03751631) compared MydCombi to phenylephrine (PE) alone and tropicamide (TR) alone, while MIST-2 (NCT03751098) compared MydCombi to placebo. All treatments were administered using Eyenovia’s Optejet technology.
Mydcombi is Eyenovia's investigational, first-in-class fixed-dose-combination product (tropicamide 1% and phenylephrine 2.5% ophthalmic spray) for pharmacologic mydriasis (eye dilation), which is targeted to improve the efficiency of the estimated 100 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. Developed as a micro-formulation for use without anesthetic, Eyenovia believes Mydcombi will help improve the efficacy, tolerability, and efficiency of pharmacologic mydriasis. Mydcombi has been licensed to Arctic Vision (Hong Kong) Limited in Greater China and South Korea.
Eyenovia Announces Receipt of California Medical Device Manufacturing License
Eyenovia also announced that on November 30, the company was awarded its California Medical Device Manufacturing license, allowing manufacturing operations to formally commence at its new facility in Redwood City, CA.