Kala Reports Positive Results for Phase III Trial of KPI-121 for Post-Cataract Surgery Pain, Inflammation

May 12, 2017: By Jon Swedien

KalaA confirmatory Phase III trial for Kala Pharmaceuticals’ product candidate for post-cataract surgery pain and inflammation produced positive topline results, the Waltham, Massachusetts, company announced May 1.

KPI-121 is a novel nanoparticle formulation of loteprednol etabonate using Kala’s mucus-penetrating particle technology to enhance penetration into tissues of the eye.

The company said it intends to submit a new drug application to the US FDA in late 2017.

In the Phase III multicenter, randomized, double-masked trial of 520 patients, KPI-121 1% was dosed twice daily for two weeks and achieved statistical significance versus placebo for both primary efficacy endpoints and all secondary endpoints, Kala said.

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 zero pain in the study eye at day eight, Kala said.

Secondary endpoints were complete resolution of anterior chamber flare at day four, complete resolution of pain at day four, and mean change in anterior chamber cells at day four. Each case maintained through day 15 with no need for rescue medication, Kala said.

The positive results followed Kala’s first Phase III trial for KPI-121 1% for post-cataract surgery pain and inflammation that concluded in 2015. In 380 patients, the treatment achieved complete resolution of ocular pain by the eighth day of treatment.

Kala also is studying KPI-121’s effectiveness as a proposed dry eye treatment in a pair of Phase III trials, expected to be completed by the end of 2017.

 

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