Kala Pharmaceuticals, Inc.: Eysuvis

CFR 314.126, that the drug product will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in its proposed labeling.

It is recommended that to demonstrate substantial evidence of efficacy in the intended patient population, data from at least one additional clinical trial be submitted in which loteprednol etabonate ophthalmic suspension, 0.25% demonstrates superiority to its vehicle in the treatment of signs and symptoms of dry eye disease.