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 (Read more...)
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