FDA Accepts Eyenovia’s Resubmitted NDA for Ophthalmic Spray

The FDA has accepted Eyenovia’s resubmitted New Drug Application (NDA) for its MydCombi ophthalmic spray, a drug-device combination product for in-office pupil dilation which uses the company’s investigational Optejet drug delivery technology.

The FDA sent the company a Complete Response Letter in October 2021 which denied approval for the original NDA and reclassified Mydcombi as a drug-device combination product.

The agency’s target action date for the resubmitted NDA is May 8, 2023.