Eyenovia ( NASDAQ: EYEN ) stock rose ~4% on Tuesday after the company said the U.S. Food and Drug Administration (FDA) accepted for review its resubmitted application seeking approval of MydCombi ophthalmic spray.
Eyenovia noted that MydCombi is a drug-device combination product which comprises the company's proprietary combination of tropicamide and phenylephrine for in-office pupil dilation (mydriasis), administered via the investigational Optejet drug delivery technology.
The FDA is expected to make a decision on the resubmitted new drug application (NDA) on May 8, 2023.
The company added that the agency also indicated that it is currently not planning to hold an advisory committee meeting to discuss the application.
In October, the FDA had rejected Eyenovia's NDA. The company had a Type A meeting with the FDA in February related to the NDA refiling.
"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," said Eyenovia CEO Michael Rowe.
The NDA is backed by data from two phase 3 trials, MIST-1 and MIST-2.
In addition, Eyenovia said that on Nov. 30, it was awarded a California Medical Device Manufacturing license, allowing manufacturing operations to formally start at its new facility in Redwood City, California.
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Eyenovia stock rises on getting FDA review for MydCombi for pupil dilation