FDA accepts Kala’s resubmission of Eysuvis NDA
Kala Pharmaceuticals announced the FDA has accepted its new drug application resubmission for Eysuvis, a candidate for the short-term treatment of dry eye disease signs and symptoms, according to a press release.
The FDA has set a Prescription Drug User Fee Act goal date of Oct. 30 for the completion of the review.
Kala resubmitted the Eysuvis (loteprednol etabonate ophthalmic suspension 0.25%) NDA in April after receiving a complete response letter from the FDA in August 2019. The letter indicated the need for additional positive clinical trial data demonstrating efficacy of Eysuvis.
Kala resubmitted the NDA with data from the phase 3 STRIDE 3 clinical trial, which saw Eysuvis meet both its primary symptom endpoints and key secondary endpoints.
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