Eyenovia announces reclassification of MydCombi as 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 III clinical program for MydCombi.
Dr. Sean Ianchulev, Chief Executive Officer and Chief Medical Officer of Eyenovia stated “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 III MicroLine study for presbyopia in the coming days.”
Eversana will serve as Eyenovia’s exclusive distributor for all customers in the United States, responsible for accepting and managing orders, payments and shipping of MydCombi to eye care offices throughout the United States.
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