Kala Pharmaceuticals has resubmitted its New Drug Application to the FDA for Eysuvis, its product candidate to treat dry eye disease.
WATERTOWN, Mass.–(BUSINESS WIRE)–Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) 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 believes this application will be considered a Class 2 resubmission, with a targeted six-month review timeline under the Prescription Drug User Fee Act (PDUFA). Kala is preparing for a potential U.S. approval and launch by the end of 2020.
Kala resubmitted the NDA in response to the complete response letter (CRL) it received from the FDA on August 8, 2019, which indicated that positive data from an additional clinical trial was needed to demonstrate efficacy and 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 (p<0.0001) and ocular discomfort severity at day 8 in the ITT population (p=0.0282). Significant results were also observed for total corneal staining at day 15 in the ITT population (p=0.0042). Consistent with prior clinical experience, EYSUVIS was well-tolerated in STRIDE 3, with adverse events and intraocular pressure increases comparable to vehicle.
“We are pleased to resubmit our NDA, marking an important step toward our goal of delivering EYSUVIS as the first prescription therapy specifically for the short-term treatment needs of patients with dry eye disease,” said Kim Brazzell, Ph.D., Chief Medical Officer of Kala Pharmaceuticals. “Our NDA submission now includes data from four clinical trials, which together, we believe, demonstrate that EYSUVIS was well-tolerated and provided rapid relief for both the signs and symptoms of dry eye disease. If approved, we look forward to delivering this important new treatment option to the approximately 17 million diagnosed dry eye patients in the U.S.”