Eyenovia Inc. (NASDAQ: EYEN) has announced the reclassification of its novel first-in-class microdose formulation combination of phenylephrine and tropicamide for in-office pupil dilation, MydCombi, as a drug-device combination therapy by the US FDA in a Complete Response Letter for its NDA received on October 22, 2021.
MyCombi reclassified as a drug-device
The company will give the FDA additional information regarding the NDA as soon as feasible, as asked in the CRL, including information needed to comply with additional obligations in Genus Medical Technologies, LLC v. FDA. The term Genus refers to a recent ruling by the United States Court of Appeals for the District of Columbia Circuit, which resulted in the FDA reclassifying certain medications as devices or drug-device combination items across the board. There were no concerns mentioned about MydCombi’s phase III clinical trial.
CEO and Chief Medical Officer of Eyenovia Dr. Sean Ianchulev said, “While we were surprised by the FDA’s position in the CRL, given our original FDA designation, we understand the unusual situation created by the impact of the Genus case, which compelled an Agency-wide reclassification. Fortunately, we had taken actions throughout the development of MydCombi to minimize the impact of a potential reclassification by the FDA. We are preparing additional documentation requested by the FDA and look forward to resubmitting our NDA in early 2022 for the FDA’s review.”
Eyenovia has adequate cash to resubmit NDA
Ianchuleve added, “Since the device used for MydCombi has commonality with that used in the MicroLine and MicroPine programs, we believe that the information submitted in support of MydCombi will pave the way in advance of those regulatory submissions. In fact, we are on track to initiate our second Phase III MicroLine study for presbyopia in the coming days.”
Currently, the company has pro forma cash of $30.7 million following the sale of 1.8 million common shares. Therefore, the amount of unrestricted and restricted cash balance is adequate for the company to resubmit the NDA for MyCombi.
