Kala Pharmaceuticals, Inc. 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 is developing EYSUVIS for a two-week course of therapy for dry eye disease, a chronic, episodic, multifactorial disease affecting the tears and ocular surface and can involve tear film instability and ocular surface damage. EYSUVIS utilizes Kala's AMPPLIFY mucus-penetrating particle (MPP) Drug Delivery Technology to enhance penetration of loteprednol etabonate (LE) into the target tissue of the eye. One Phase 2 and three Phase 3 clinical trials, STRIDE 1, STRIDE 2 and STRIDE 3, have been completed for EYSUVIS.
On August 8, 2019, the FDA stated 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 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. Key secondary endpoints were also achieved for conjunctival hyperemia and ocular discomfort severity. Consistent with past findings, adverse events and intraocular pressure increases were comparable to vehicle.
“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,” said Kim Brazzell, Ph.D., Chief Medical Officer of Kala Pharmaceuticals.
Full press release: http://investors.kalarx.com/news-releases/news-release-details/kala-pharmaceuticals-resubmits-new-drug-application-eysuvistm
Source: Kala Pharmaceuticals