Eyenovia, Inc.: MYDCOMBI

Please refer to your new drug application (NDA) dated and December 28, 2020, and your amendments, submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act for MYDCOMBI (tropicamide and phenylephrine hydrochloride ophthalmic spray), 1%/2.5%.

©® drug product manufacturing facility for this application, our field investigator conveyed deficiencies to the representative of the facility.

Satisfactory resolution of these deficiencies is required before this application may be approved.

Cosmetic Act do not include adequate tests by all methods reasonably applicable to show whether or not the drug is safe for use under the conditions prescribed, recommended, or suggested in its proposed labeling.

As the drug constituent part provides the PMOA, CDER will have primary jurisdiction over these products, including your product.

For each submission for this application, indicate that the product is a combination product in field #24 of the FDA Form 356h.

Answers, from Oct 2019. For combination products, facilities manufacturing a constituent part of a co-package or single entity combination product, or drug-device combination product that are proposed to be involved in the disposition of commercial product should be included on Form 356h.

8. You have not submitted human factors validation study data to demonstrate that your user interface supports the safe and effective use of your product by the intended users, for intended uses, and in the intended use environment.

We recommend you include a comprehensive use-related risk analysis if you have not already completed one.

The comprehensive use-related risk analysis should include a comprehensive and systematic evaluation of all the steps involved in using your product (e.g., based on a task analysis) the errors that users might commit or the tasks they might fail to perform and the potential negative clinical consequences of use errors and task failures.

The risk analysis can be used to inform the design of a human factors validation study protocol for your product.