Kala Pharmaceuticals, Inc. (Kala) announced earlier this week positive topline results from STRIDE 3, a Phase 3 clinical trial evaluating a dry eye disease treatment, KPI-121 0.25%, which Kala plans to commercialize under the brand name EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25%.
STRIDE 3 met both of its primary efficacy endpoints, demonstrating a statistically significant improvement in the symptom endpoint of ocular discomfort severity (ODS) at day 15 in the overall intent-to-treat (ITT) population and in the predefined subgroup of ITT patients with more severe ocular discomfort. Statistical significance was also achieved in the key secondary endpoints of conjunctival hyperemia at day 15 and ODS at day 8 in the ITT population.
EYSUVIS was well tolerated, with adverse events and intraocular pressure increases comparable to vehicle. Kala plans to utilize these data as the basis for a Class 2 resubmission of the New Drug Application (NDA) for EYSUVIS in the second quarter of 2020, with an expected six-month review timeline by the U.S. Food and Drug Administration (FDA).
“These data reinforce the potential of EYSUVIS to transform the treatment landscape for dry eye disease,” said Dr. Edward Holland, Director of Cornea Services at Cincinnati Eye Institute and Professor of Ophthalmology at the University of Cincinnati. “EYSUVIS would be the first prescription dry eye product developed specifically to address the acute treatment needs of patients with dry eye disease, including dry eye flares that are experienced by the vast majority of patients. If approved, I believe EYSUVIS would become a first-line therapy for patients at all stages of dry eye disease.”
“We are thrilled with the results of STRIDE 3, which build on our prior clinical experience with EYSUVIS in our Phase 2, STRIDE 1 and STRIDE 2 trials,” said Mark Iwicki, Chairman, President and Chief Executive Officer of Kala Pharmaceuticals. “We would like to express our sincere appreciation to the investigators and nearly 3,000 patients who participated in the trials. We are now focusing on finalizing the NDA resubmission, which is targeted for the second quarter of 2020, and on preparing for a potential U.S. approval and launch by the end of the year. We look forward to delivering this important new medicine to patients.”
Full news release: https://www.businesswire.com/news/home/20200309005294/en/Kala-Pharmaceuticals-Announces-Statistically-Significant-Results-Primary/
Source: Kala Pharmaceuticals