Positive results from Phase III trial of KPI-121 1% for the treatment of inflammation and pain in cataract surgery patients .- Kala Pharmaceuticals

Kala Pharmaceuticals, Inc. a developer of innovative ophthalmic medicines based on its proprietary mucus-penetrating particle (MPP) technology, announced positive top-line results from its confirmatory Phase III trial of KPI 121 1% for the treatment of inflammation and pain in patients who have undergone cataract surgery. KPI 121 1% dosed twice-a-day for two weeks achieved statistical significance versus placebo for both primary efficacy endpoints and all secondary endpoints.

KPI 121 1% was well tolerated with no significant treatment-related safety findings observed during the trial. The Phase III multi-center, randomized, double-masked, placebo-controlled, parallel-group trial in 520 patients was designed to evaluate the efficacy and safety of KPI 121 1% ophthalmic suspension dosed twice-a-day, versus placebo, in patients who experienced anterior ocular inflammation following cataract surgery. Patients were randomized to receive either KPI 121 1% or corresponding placebo, and both were administered twice-a-day for two weeks, with evaluations at days four, eight and 15. The primary efficacy endpoints were the proportion of patients with complete resolution of anterior chamber cells (a marker of ocular inflammation) in the study eye at day eight, and the proportion of subjects with Grade 0 pain in the study eye at day eight.

Statistically significant differences favoring KPI 121 1% administered twice-a-day versus placebo were achieved for both primary endpoints, the proportion of patients with complete resolution of anterior chamber cells at day 8 (p=0.01) and proportion of patients with complete resolution of ocular pain at day 8 (p<0.0001). statistical significance was also achieved for all predefined secondary endpoints (complete resolution of anterior chamber flare at day 4, complete resolution of pain at day 4, and mean change in anterior chamber cells at day 4). each case maintained through day 15 with no need for rescue medication.>