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Positive results seen for KPI-121 in treatment of inflammation, pain after cataract surgery
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A confirmatory phase 3 trial of KPI-121 for the treatment of inflammation and pain in patients who have undergone cataract surgery has shown positive top-line results, according to a press release from Kala Pharmaceuticals.
KPI-121 1% was dosed twice a day for 2 weeks in a 520-patient, multicenter, randomized, double-masked, placebo-controlled, parallel-group trial and showed statistical significance for both of its primary efficacy endpoints and all of its secondary endpoints vs. placebo, the release said.
“The significant improvement in the treatment of inflammation and pain with twice-a-day dosing of KPI-121 in this trial builds on the success of our first phase 3 trial in cataract surgery,” Kim Brazzell, PhD, chief medical officer of Kala, said in the release.
The company plans to submit a new drug application for KPI-121 1% to the FDA later this year, he added.