Safety and efficacy of KPI-121 0.25% for the treatment of signs and symptoms of dry eye disease in three multicentre randomised, double-masked, vehicle-controlled trials

Session Details

Session Title: Presented Poster Session: Medical Cornea

Venue: Poster Village: Pod 3

First Author: : E.Holland USA

Co Author(s): :    K. Nichols   G. Foulks   P. Gupta   K. Sall   R. Brazzell   S. Coultas        

Abstract Details

Purpose:

To evaluate the safety and efficacy of two-week treatment with KPI 121 0.25%, a mucus penetrating, nanoparticle loteprednol etabonate ophthalmic suspension compared to vehicle in subjects with dry eye disease (DED) in one Phase 2 and two Phase 3 clinical trials

Setting:

Two Phase 3, 2-week and one Phase 2, 4-week randomized, double-masked, vehicle-controlled trials were conducted in DED subjects at sites in the United States (2016-2017). The Phase 3 trials had 911 KPI-121 0.25% subjects and 909 vehicle. The Phase 2 trial had 73 KPI-121 0.25% subjects and 77 vehicle.

Methods:

A total of 1970 subjects with DED (≥18 yrs) across three clinical trials were randomized 1:1 (KPI-121 0.25%: Vehicle) ratio to receive loteprednol etabonate or vehicle four times daily (QID) for two weeks in the Phase 3 trials (NCT02813265; NCT02819284) or 4 weeks in the Phase 2 trial (NCT 02188160).  A total of 984 patients were treated with KPI-121 0.25% and 986 patients were treated with vehicle following a 2-week vehicle run-in period. Main efficacy outcome measures included conjunctival hyperemia (CH) and subject-reported ocular discomfort severity (ODS) scores at Day 15. Safety and tolerability were also assessed.

Results:

Significant improvements for the sign endpoint CH at Day15 were seen for KPI-121 vs vehicle in all three trials (p ≤ 0.009). Significant improvement in ODS at Day15 for KPI-121 vs vehicle was seen in the Phase 2 trial (p= 0.0489) and the first Phase 3 trial (p< 0.0001; primary endpoint). A positive treatment trend was also seen in the second Phase 3 trial (p=0.1298). The most frequently reported adverse event was instillation site pain (5.7 to 6.1% for KPI-121 vs 4.4 to 6.1% for vehicle). The incidence of intraocular pressure (IOP) increase was similar for KPI-121 and vehicle.

Conclusions:

KPI-121 0.25% improved both signs and subject-reported symptoms of DED when dosed QID for 2 weeks in subjects with a documented clinical diagnosis of DED compared with vehicle. KPI 121 0.25% appeared to be safe and well-tolerated in all three trials. The incidence of IOP elevation, a known side effect associated with topical corticosteroids use, was similar between the KPI-121 and vehicle arms in all three trials.

Financial Disclosure:

... is employed by a for-profit company with an interest in the subject of the presentation