Posted by Michael Wonder on 06 May 2020
Kala Pharmaceuticals resubmits new drug application for Eysuvis for dry eye disease
4 May 2020 - Kala Pharmaceuticals today announced that it has resubmitted its new drug application to the U.S. FDA for Eysuvis (loteprednol etabonate 0.25% ophthalmic suspension) its product candidate for the short-term treatment of the signs and symptoms of dry eye disease.
Kala believes this application will be considered a Class 2 resubmission, with a targeted six month review timeline under the Prescription Drug User Fee Act.
Kala is preparing for a potential U.S. approval and launch by the end of 2020.
