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# FDA Accepts NDA for Eye Dilating Combo Product
- URL: https://www.fdaweb.com/fda-accepts-nda-for-eye-dilating-combo-product/
- Published: 2022-12-13T12:00:00.000Z
- Updated: 2026-09-14T18:09:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153379

FDA has accepted for review an Eyenovia resubmitted NDA for MydCombi ophthalmic spray, a drug-device combination product that comprises tropicamide and phenylephrinem, which is delivered using its Optejet drug delivery technology, for in-office pupil dilation. The agency has assigned it a standard review and a 5/8/2023 user fee review action target date.

Last year, FDA issued the company a complete response letter on the initial NDA because the agency reclassified the drug as a drug-device combination product. The reclassification was prompted by FDA’s 2021 court loss ([see earlier story](https://www.fdaweb.com/court-hits-fda-discretion-in-drug-device-decisions/)) in *Genus Medical Technologies, LLC v. FDA*, according to the company. About the same time, FDA announced it was implementing the appeals court decision affirming a district court ruling that it is not afforded discretion when a combination product meets the definition of both a device and a drug. A [notice](https://public-inspection.federalregister.gov/2021-16944.pdf?ref=fdaweb.com) provided information about the way in which impacted products should be transitioned from drug to device status.

The NDA is based on data from the MIST-1 and MIST-2 studies. They showed that about 94% of treated eyes achieved 6 mm or greater dilation at 35 minutes post-instillation, according to the company. Adverse events were infrequent, with fewer than 1% of patients reporting blurred vision, reduced acuity, photophobia or instillation site pain.