FDA accepts NDA for MydCombi ophthalmic spray for in-office pupil dilation (mydriasis)
Eyenovia, Inc.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 FDA 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.
The MydCombi NDA is supported by two completed Phase III 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.
See- "Mydriasis with micro-array print touch-free tropicamide-phenylephrine fixed combination MIST: pooled randomized Phase III trials"-David L Wirta, Thomas R Walters, William J Flynn, Siddarth Rathi & Tsontcho Ianchulev Therapeutic Delivery.Volume 12, Issue 301 Mar 2021.
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