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 six-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.
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 for two weeks in approximately 900 patients with dry eye disease. Subjects who meet initial screening and inclusion/exclusion criteria undergo a two-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.
Kala is developing KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease utilizing a two-week course of therapy.
Dry eye disease is a chronic, episodic, multifactorial disease affecting the tears and ocular surface and can involve tear film instability, inflammation, discomfort, visual disturbance and ocular surface damage.
KPI-121 0.25% utilizes Kala's AMPPLIFY mucus-penetrating particle Drug Delivery Technology to enhance penetration of loteprednol etabonate into target tissue of the eye. Kala has completed one Phase 2 and two Phase 3 clinical trials, STRIDE 1 and STRIDE 2 (STRIDE - Short Term Relief In Dry Eye), of KPI-121 0.25%.
A third Phase 3 study, STRIDE 3, is currently ongoing and Kala is targeting topline data by the end of 2019. Kala believes that KPI-121 0.25%'s broad mechanism of action, rapid onset of relief of both signs and symptoms, favourable tolerability and safety profile and the potential to be complementary to existing therapies, could result in a favorable profile for the management of dry eye flares and other dry eye associated conditions.
Kala is a biopharmaceutical company focused on the development and commercialisation of therapeutics using its proprietary AMPPLIFY mucus-penetrating particle Drug Delivery Technology, with an initial focus on the treatment of eye diseases.
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