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# Kala Pharma Dry Eye NDA Rejected; More Data Needed
- URL: https://www.fdaweb.com/kala-pharma-dry-eye-nda-rejected-more-data-needed/
- Published: 2019-08-09T12:00:00.000Z
- Updated: 2026-09-15T01:42:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144733

FDA has sent Kala Pharmaceuticals a complete response letter (CRL) on its NDA for KPI-121 (loteprednol etabonate) 0.25% for the temporary relief of dry eye disease signs and symptoms. The agency letter recommended efficacy data from an additional clinical trial before resubmission, the company says. Kala says it continues to enroll patients in its ongoing STRIDE 3 Phase 3 clinical trial, and expects this trial will serve as the basis of its response to the CRL.

Kala began STRIDE 3 7/2018 based on an FDA recommendation. Its trial design reflects specific modifications to the inclusion and exclusion criteria of Kala’s previous trials, and the changes were implemented to improve the probability of success, it says. Topline data from STRIDE 3 is expected by the end of this year and resubmission of the NDA during the first half of 2020, it adds.