Successful Phase III trial for KPI 121 for pain management after cataract surgery- Kala Pharma

Kala Pharmaceuticals, Inc. announced positive top-line results from a Phase III clinical trial of KPI-121, its nanoparticle loteprednol etabonate MPP product candidate, for the treatment of inflammation and pain in patients who had undergone cataract surgery. KPI-121 achieved all primary efficacy endpoints and was generally well tolerated, with no significant treatment-related safety findings observed during the course of the trial.

The Phase III multi-center, randomized, double-masked, vehicle-controlled, parallel-group trial in 380 patients was designed to evaluate two dosing regimens of KPI-121 ophthalmic suspension versus vehicle in patients undergoing cataract surgery. Patients were randomized to receive either 0.25% KPI-121 four times daily, 1.0% KPI-121 two times daily or their corresponding vehicles administered for two weeks. At day eight, statistically significant differences favoring KPI-121 were achieved for the primary endpoint of complete resolution of inflammation with both 1% KPI-121 dosed twice a day (p=0.0024) and 0.25% KPI-121 dosed four times a day (p < 0.0001). Complete resolution of ocular pain by day eight (also a primary endpoint) was achieved for 1% KPI-121 dosed twice a day (p=0.0019) and 0.25% KPI-121 dosed four times a day (p=0.0003).