Kala Pharmaceuticals announced that it has completed enrollment in its STRIDE 3 (STRIDE – Short Term Relief In Dry Eye) phase 3 clinical trial for KPI-121 0.25%, its product candidate for the short-term treatment of dry eye disease. If approved, Kala plans to commercialize KPI-121 0.25% under the brand name Eysuvis. Kala is targeting to report topline results from this trial during the first quarter of 2020 and resubmission of the Eysuvis new drug application (NDA) to the FDA in the first half of 2020. Kala believes this resubmission would be subject to a 6-month review.
“Today’s announcement represents a significant milestone for Kala,” Kim Brazzell, Chief Medical Officer of Kala, said in a company news release. “If approved, we believe Eysuvis could become the preferred prescription therapy for dry eye flares, which affect the vast majority of dry eye patients. We thank the many patients who participated in this trial, and we are also grateful to our study sites and investigators.”
The STRIDE 3 trial is a multicenter, randomized, double-masked, placebo-controlled, parallel-arm study, comparing Eysuvis 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 Eysuvis or vehicle for 2 weeks. The STRIDE 3 trial design reflects specific modifications to the inclusion and exclusion criteria of Kala’s previous trials of Eysuvis, which were implemented to improve the probability of success. Kala expects that data from the STRIDE 3 trial will serve as the basis for the resubmission of the Eysuvis NDA to the FDA.