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Kala’s KPI-121 resolves inflammation, pain after cataract surgery in phase 3 trial

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Kala Pharmaceuticals released positive topline results from a phase 3 trial of KPI-121 for the treatment of pain and inflammation in patients who underwent cataract surgery, according to a press release.

All primary efficacy endpoints were achieved, KPI-121 was well tolerated, and there were no treatment-related safety issues during the trial, the release said.

The phase 3 multicenter, randomized, double-masked, vehicle-controlled, parallel group trial included 380 patients who received KPI-121, a nanoparticle loteprednol etabonate MPP product candidate, after cataract surgery. Patients received 0.25% KPI-121 four times daily, 1% KPI-121 two times daily or corresponding vehicles for 2 weeks.

Patients treated with 1% KPI-121 twice daily and 0.25% KPI-121 four times daily achieved the primary endpoints of complete resolution of inflammation and ocular pain by day 8, the release said. The differences between KPI-121 vs. the corresponding vehicle treatments were statistically significant.