AACE Pharmaceuticals, Inc. – FDA CRL

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) on August 7, 2019, to Kala Pharmaceuticals, Inc. for its New Drug Application (NDA 210933) concerning Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25%. The FDA determined that the application cannot be approved in its present form due to a lack of substantial evidence of efficacy. Specifically, two clinical trials, KPI-121-C-002 and KPI-121-C-007, failed to demonstrate superiority of the drug product for its primary symptom endpoint, as required by 21 CFR 314.126 under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. To address this, the FDA recommends submitting data from at least one additional clinical trial demonstrating superiority of Eysuvis over its vehicle in treating signs and symptoms of dry eye disease. Required actions also include resubmitting the proposed proprietary name, providing a comprehensive safety update, and revising labeling to conform with Structured Product Labeling (SPL) format and FDA guidelines. Kala Pharmaceuticals has one year to resubmit the application or take other actions, with the option to request a meeting to discuss further steps. The drug cannot be legally marketed until formal approval is granted.