Kala Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) resubmission for EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25%, its product candidate for the short-term treatment of the signs and symptoms of dry eye disease.
Kala resubmitted the EYSUVIS NDA in April 2020, in response to the CRL it received from the FDA in August 2019, which indicated that positive data from an additional clinical trial was needed to support a resubmission of the NDA. The positive results from STRIDE 3 for both signs and symptoms of dry eye disease, along with the positive data from the previous clinical trials of EYSUVIS, served as the basis for Kala’s NDA resubmission package.
The phase 3 trial demonstrated improvement in ocular discomfort severity in both the overall intent-to-treat (ITT) population and in a predefined subgroup of ITT patients with more severe ocular discomfort at baseline. Consistent with prior clinical experience, EYSUVIS was also well-tolerated in STRIDE 3, with adverse events and intraocular pressure increases comparable to vehicle.
The FDA stated that the NDA resubmission is a complete, Class 2 response to the Complete Response Letter (CRL) issued in August 2019, and the FDA set a Prescription Drug User Fee Act (PDUFA) goal date of October 30, 2020 for the completion of its review of the NDA.
“The FDA’s acceptance of our NDA resubmission signifies critical progress toward our goal of delivering EYSUVIS as the first prescription medicine for the short-term treatment of dry eye disease,” said Kim Brazzell, Ph.D., Chief Medical Officer of Kala Pharmaceuticals. “We are very appreciative that the Agency set a standard Class 2 review timeline, despite the ongoing pandemic, and we look forward to working together through their review of our NDA submission.”
Full news release: https://investors.kalarx.com/news-releases/news-release-details/kala-pharmaceuticals-announces-fda-acceptance-new-drug
Source: Kala Pharmaceuticals