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# Eyenovia ‘Complete Response’ Related to Genus Decision
- URL: https://www.fdaweb.com/eyenovia-complete-response-related-to-genus-decision/
- Published: 2021-10-25T12:00:00.000Z
- Updated: 2026-09-14T17:20:10.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150435

Eyenovia has received a complete response letter on its NDA for MydCombi (tropicamide and phenylephrine), indicated for in-office pupil dilation, because the agency had reclassified the drug as a drug-device combination product. The reclassification was prompted by FDA’s recent 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.

In August, FDA announced it was implementing an 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. The [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 Mydcombi NDA was filed in March as a drug after FDA determined that an accompanying eye dropper would not make it a combination product. Eyenovia says it will provide in early 2022 additional information to the agency as requested in the letter to meet the new requirements the *Genus* decision creates.

The NDA was 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.