Phase 3 Trial Demonstrates Significant Improvement in Symptom Endpoint of Ocular Discomfort Severity
Results from a Phase 3 clinical trial evaluating KPI-121 0.25% demonstrated statistically significant improvement in ocular discomfort severity (ODS), according to a company press release.
Kala Pharmaceuticals, Inc plans to commercialize KPI-121 0.25% under the brand name Eysuvis (loteprednol etabonate ophthalmic suspension) 0.25%.
In the multicenter, randomized, double-masked, placebo-controlled, parallel-arm study, 901 patients with dry eye disease were given Eysuvis (n = 447) or placebo (454) 4 times a day for 2 weeks. Patients recorded ODS daily using a visual analog grading scale. Patients who met initial screening and inclusion/exclusion criteria underwent a 2-week run-in period with vehicle. Patients who continued to meet inclusion/exclusion criteria after the run-in were then randomized to receive either Eysuvis or vehicle for 2 weeks.
There was a statistically significant reduction in the symptom endpoint of ODS from baseline to day 15 compared to vehicle control in the overall intent-to-treat (ITT) population (P = 0.0002). There was also a statistically significant reduction in a pre-defined subgroup of patients who scored ≥68 mm in baseline ocular discomfort (P = 0.0007).
The secondary endpoint of conjunctival hyperemia at day 15 was statistical significance in the ITT population (P < 0.0001).
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