Kala Pharmaceuticals announced that it received a complete response letter (CRL) from the FDA regarding the company’s new drug application (NDA) for KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease. The FDA indicated that efficacy data from an additional clinical trial will be needed to support a resubmission.
Kala continues to enroll patients in its ongoing STRIDE 3 (STRIDE – Short Term Relief In Dry Eye) phase 3 clinical trial, and expects this trial will serve as the basis of its response to the CRL. Kala is targeting topline data from STRIDE 3 by the end of 2019 and resubmission of the NDA during the first half of 2020. The company believes this resubmission would be subject to a 6-month review under the Prescription Drug User Fee Act. Kala initiated STRIDE 3 in July 2018 at the recommendation of the FDA. The STRIDE 3 trial design reflects specific modifications to the inclusion and exclusion criteria of Kala’s previous trials of KPI-121 0.25%, which were implemented to improve the probability of success.
“We remain confident in the potential of KPI-121 0.25% to be the first approved product for the temporary relief of the signs and symptoms of dry eye disease,” Kim Brazzell, Chief Medical Officer of Kala Pharmaceuticals, said in a company news release. “We look forward to reporting data from STRIDE 3 and resubmitting the NDA with the goal of obtaining approval and being able to offer KPI-121 0.25% to the millions of patients with dry eye disease.”
The STRIDE 3 trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-arm study, comparing KPI-121 0.25% to vehicle (placebo), each dosed four times a day (QID) for 2 weeks in approximately 900 patients with dry eye disease. Subjects who meet initial screening and inclusion/exclusion criteria undergo a 2-week run-in period with vehicle. Subjects who continue to meet inclusion/exclusion criteria after the run-in are randomized to receive either KPI-121 0.25% or vehicle for two weeks.
The NDA for KPI-121 0.25% included data from one phase 2 and two phase 3 efficacy and safety trials, STRIDE 1 and STRIDE 2, studying approximately 2,000 patients with dry eye disease.