Posted by Michael Wonder on 27 Dec 2018
Kala Pharmaceuticals announces new drug application for KPI-121 0.25% for dry eye disease has been accepted for review by the U.S. FDA
26 December 2018 - KPI-121 0.25% expected to be the first product indicated for the temporary relief of signs and symptoms of dry eye disease, if approved.
Kala Pharmaceuticals today announced that the new drug application for KPI-121 0.25%, a product candidate for the temporary relief of signs and symptoms of dry eye disease utilizing a two-week course of therapy, has been accepted for review by the United States FDA.
The FDA has set a target action date under the Prescription Drug User Fee Act of 15 August 2019. If approved, KPI-121 0.25% is expected to be the first product indicated for the temporary relief of the signs and symptoms of dry eye disease, which would include treatment of dry eye flares.
