Kala has completed enrollment in its Phase 3 clinical trial for its product candidate for the short-term treatment of dry eye disease.
Kala Pharmaceuticals (NASDAQ:KALA) announced that it has completed enrollment in its STRIDE 3 Phase 3 clinical trial for KPI-121 0.25%, its product candidate for the short-term treatment of dry eye disease.
As quoted in the press release:
If approved, Kala plans to commercialize KPI-121 0.25% under the brand name EYSUVIS™. Kala is targeting to report top-line results from this trial during the first quarter of 2020 and resubmission of the EYSUVIS New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the first half of 2020. Kala believes this resubmission would be subject to a six-month review.
“Today’s announcement represents a significant milestone for Kala,” said Kim Brazzell, Chief Medical Officer of Kala. “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.”