May 04, 2020
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Kala Pharmaceuticals resubmits NDA for Eysuvis
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Kala Pharmaceuticals resubmitted a new drug application to the FDA for Eysuvis, a candidate for the short-term treatment of dry eye disease signs and symptoms, according to a company press release.
Kala received a complete response letter from the FDA in August 2019, indicating the need for additional positive clinical trial data demonstrating efficacy of Eysuvis (loteprednol etabonate ophthalmic suspension 0.25%). It is now preparing for potential U.S. approval and launch later this year.
In March, data for the phase 3 STRIDE 3 clinical trial were released, and Eysuvis met both of its primary symptom endpoints and key secondary endpoints.
Kala expects a 6-month review timeline under the Prescription Drug User Fee Act.