Kala Pharmaceuticals said that its dry eye disease candidate KPI-121 0.25% has delivered positive results in a phase 3 trial called STRIDE 3.
Planned to be branded as EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25%, KPI-121 showed statistically significant results for primary and also key secondary endpoints in comparison to placebo in the late-stage trial.
The STRIDE 3 trial met its two primary efficacy endpoints by delivering a statistically significant improvement in the symptom endpoint of ocular discomfort severity (ODS) at day 15. These were noted in the overall intent-to-treat (ITT) population and in the predefined subgroup of ITT patients with more severe ocular discomfort at baseline.
According to Kala Pharmaceuticals, statistical significance was also noted in the main secondary endpoints of conjunctival hyperemia at day 15 in the ITT population and ODS at day 8 in the ITT population.
The company expects to use the data from the STRIDE 3 trial as the basis for a Class 2 resubmission of KPI-121’s new drug application to the US Food and Drug Administration (FDA). The resubmission is planned to be made by the Massachusetts-based clinical-stage pharma company in the second quarter of this year.
Kala Pharmaceuticals submitted an NDA for KPI-121 in December 2018 based on the phase 2 STRIDE 1 and phase 3 STRIDE 2 trials. However, in August 2019, the FDA issued the company a complete response letter (CRL) seeking efficacy data from an additional clinical trial to back a resubmission.
The STRIDE 3 trial, which featured 901 patients with dry eye disease, has been expected to serve as the basis of the company’s response to the FDA’s CRL.
Kala Pharmaceuticals chairman, president and CEO Mark Iwicki said: “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.
“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.”
