Santen, Inc.: Omlonti

Cosmetic Act (FDCA), for Omlonti (omidenepag isopropyl ophthalmic solution), 0.002%.

211, and the methods to be used in, and the facilities and controls used for, the manufacture, processing, packing, or holding of the drug substance or the drug product are inadequate to preserve its identity, strength, quality, purity, stability, and bioavailability.

During a recent inspection of the of the | 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.

Satisfactory resolution of the remaining objectionable conditions, and verification by FDA, 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.

Study 1171504 demonstrated significant endothelial cell loss in both omidenepag isopropyl ophthalmic solution monotherapy arms particularly between Weeks 12 and 26. In the absence of a control arm without omidenepag isopropyl treatment, the trial is suggestive of potential harm to the corneal endothelial cells.

A concurrently controlled, randomized, 12-month clinical study in which omidenepag isopropyl ophthalmic solution is dosed as monotherapy and corneal endothelial cell counts are compared to a concurrent control without omidenepag isopropyl should be conducted and submitted.

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.

CBER and CDER, Questions and 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.

Based on an assessment of the risk profile of your proposed combination product, FDA has determined that information to demonstrate compliance with the device QS regulation is most appropriately assessed during inspection, and this information must be available upon inspection to demonstrate your compliance with 21 CFR part 4.

We acknowledge your proposal, dated August 31, 2021, to withdraw the analytical testing site, © from the application and commit to a post-approval supplement for a new analytical laboratory.

We therefore recommend proposing an alternative facility to handle those responsibilities in the application prior to withdrawing the | facility.