Eyenovia Announces Reclassification of MydCombi as Drug-Device Combination Product by FDA

In a Complete Response Letter (CRL) from the FDA, Eyenovia announced that MydCombi, the company’s proprietary, first-in-class combination microdose formulation of tropicamide and phenylephrine for in-office pupil dilation, has been reclassified as a drug-device combination product.

Eyenovia will provide additional information to the FDA, as requested in the CRL, as soon as possible, including information necessary to meet additional requirements under Genus Medical Technologies, LLC v. FDA. Genus refers to a recent decision by the U.S. Court of Appeals for the District of Columbia Circuit which has resulted in an agency-wide reclassification by FDA of certain drugs to devices or to drug-device combination products. There were no issues raised related to the phase 3 clinical program for MydCombi.

“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,” Sean Ianchulev, MD, PhD, Chief Executive Officer and Chief Medical Officer of Eyenovia, said in a company news release. “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. 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 3 MicroLine study for presbyopia in the coming days.”

The company’s current total pro forma cash balance is approximately $30.7 million after the sale of approximately 1.8 million shares of common stock earlier this quarter through the company’s At The Market offering facility. The company believes its total unrestricted and restricted cash balance will be sufficient for the resubmission of the NDA for MydCombi, completion of the MicroLine clinical program, and other planned activities through the beginning of 2023.

Eyenovia announced FDA acceptance of the MydCombi NDA in March 2021. The NDA was based on the MIST-1 and MIST-2 studies. In these two phase 3 studies, a fixed combination of micro-dosed tropicamide 1% and phenylephrine 2.5% ophthalmic solution met the studies’ primary endpoints and was shown to be well-tolerated and effective for pharmacologic mydriasis. Approximately 94% of treated eyes achieved 6mm or greater dilation at 35 minutes post-instillation. Adverse events were infrequent, with fewer than 1% of patients reporting blurred vision, reduced acuity, photophobia or instillation site pain.