Posted by Michael Wonder on 10 Aug 2019
Kala Pharmaceuticals receives FDA complete response letter for KPI-121 0.25% NDA and plans to respond with data from STRIDE 3 trial
8 August 2019 - Targeting top-line data from STRIDE 3 by the end of 2019.
Kala Pharmaceuticals today announced that it received a complete response letter from the U.S. FDA regarding the Company’s new drug application for KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease.
The FDA indicated that efficacy data from an additional clinical trial will be needed to support a resubmission.
