Eyenovia shares plummeted by around 38% in morning trading on Tuesday after the FDA issued a Complete Response Letter (CRL) for MydCombi™, the company’s proprietary, first-in-class combination microdose formulation of tropicamide and phenylephrine for in-office pupil dilation.
According to the letter, the FDA has reclassified MydCombi™ as a drug-device combination product and urged Eyenovia to provide additional information as soon as possible, including information necessary to meet additional requirements under Genus Medical Technologies, LLC v. FDA.
The term Genus refers to a recent ruling by the U.S. Court of Appeals for the District of Columbia Circuit, which resulted in FDA reclassifying certain medications as devices or drug-device combination items across the board.
There were no concerns mentioned about MydCombi's phase 3 clinical trial.
“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.”
Following the sale of roughly 1.8 million shares of common stock through the company's At The Market offering facility earlier this quarter, the company's total pro forma cash balance is currently around $30.7 million.
The business expects that its total unrestricted and restricted cash balances will be sufficient to fund the resubmission of the MydCombi NDA, the completion of the MicroLine clinical program, and other planned activities until the first quarter 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.
A fixed combination of micro-dosed tropicamide 1% and phenylephrine 2.5% ocular solution met the studies' primary outcomes and was demonstrated to be well-tolerated and efficacious for pharmacologic mydriasis in these two phase 3 investigations.
At 35 minutes after instillation, almost 94% of treated eyes had dilatation of 6mm or more. Fewer than 1% of patients reported impaired vision, diminished acuity, photophobia, or instillation site pain.
MydCombi™ has the potential to increase patient throughput at practicing offices by decreasing time spent eye dropping patients, eliminating time wasted waiting between drop instillations and ensuring more accurate drug delivery.