PMID- 30643381 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220409 IS - 1177-5467 (Print) IS - 1177-5483 (Electronic) IS - 1177-5467 (Linking) VI - 13 DP - 2019 TI - Safety and efficacy of twice daily administration of KPI-121 1% for ocular inflammation and pain following cataract surgery. PG - 69-86 LID - 10.2147/OPTH.S185800 [doi] AB - PURPOSE: KPI-121 is a nanoparticle suspension of loteprednol etabonate with improved ocular pharmacokinetics compared with marketed formulations. The efficacy and safety of KPI-121 1% ophthalmic suspension (INVELTYS) dosed twice daily (BID) were evaluated in participants who had undergone cataract surgery. MATERIALS AND METHODS: In two multicenter, randomized, double-masked, parallel-group, vehicle-controlled clinical trials, 386 participants with >/= grade 2 anterior chamber cells (>/=6 cells) on the day following routine cataract surgery were treated with KPI-121 1% and 325 participants were treated with placebo (vehicle); each group was dosed BID for 2 weeks. Primary efficacy endpoints were complete resolution of ocular inflammation by slit-lamp biomicroscopy and complete resolution of subject-rated ocular pain at Days 8 and 15 with no rescue medication before Day 15. Safety assessments included adverse events (AEs), visual acuity, intraocular pressure measurements, and evaluation of ocular AEs by slit-lamp biomicroscopy and dilated ophthalmoscopy. RESULTS: Both trials achieved statistical significance favoring KPI-121 1% BID for both primary efficacy endpoints. Combined data analysis showed that significantly more participants treated with KPI-121 vs vehicle achieved complete resolution of anterior chamber cells at Days 8 and 15 (P