Kala Pharmaceuticals, Inc, a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today 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. 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.”
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. As announced in March 2020, STRIDE 3, a Phase 3 clinical trial of EYSUVIS, met both of its primary symptom endpoints, demonstrating a statistically significant 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. Additionally, statistical significance was achieved in the key secondary endpoints of conjunctival hyperemia at day 15 in the ITT population and ocular discomfort severity at day 8 in the ITT population. Significant results were also observed for total corneal staining at day 15 in the ITT population. Consistent with prior clinical experience, EYSUVIS was well-tolerated in STRIDE 3, with adverse events and intraocular pressure increases comparable to vehicle.