Copenhagen 2016 Registration Programme Exhibitor Information Virtual Exhibition Satellite Meetings Glaucoma Day 2016 Hotel Star Alliance
title

10 - 14 Sept. 2016, Bella Center, Copenhagen, Denmark

This Meeting has been awarded 27 CME credits

 

escrs app advert yo advert

Posters

Search Title by author or title

Efficacy and safety of lifitegrast ophthalmic solution 5.0% in three randomized controlled trials for dry eye disease

Poster Details

First Author: A. Cummings IRELAND

Co Author(s):    C. Baudouin   E. Holland   W. Whitley   K. Sall   S. Lane   A. Raychaudhuri   S. Zhang   A. Shojaei

Abstract Details

Purpose:

To evaluate efficacy and safety of lifitegrast ophthalmic solution 5.0% across three randomized, placebo-controlled trials (one phase 2 and two phase 3) in participants with dry eye disease (DED). Lifitegrast is a novel integrin antagonist, currently under investigation for the treatment of DED. The three trials, phase 2, OPUS-1 (phase 3) and OPUS-2 (phase 3), were of similar design, allowing the results to be evaluated as a continuum of evidence.

Setting:

Three 12-week randomized, double-masked, placebo-controlled trials conducted at multiple sites in the United States between 2009 and 2013. In the phase 2 trial, n=58 participants were randomized to lifitegrast 5.0% and n=58 placebo; in OPUS-1, n=293 lifitegrast 5.0% and n=295 placebo; in OPUS-2, n=358 lifitegrast 5.0% and n=360 placebo.

Methods:

Changes from baseline to day 84 in signs and symptoms of DED were analyzed for lifitegrast ophthalmic solution 5.0% versus placebo. Change from baseline to day 84 in inferior corneal staining score (ICSS, 0–4 scale) was a secondary endpoint in the phase 2 trial. OPUS-1 had coprimary endpoints of change from baseline to day 84 in ICSS and the visual-related function subscale of a symptom scale (0–4 scale). OPUS-2 coprimary endpoints were change from baseline to day 84 in ICSS and eye dryness score (EDS, visual analog scale [VAS], 0–100).

Results:

Lifitegrast improved ICSS versus placebo in the phase 2 study (treatment effect, 0.35; 95% CI, 0.05–0.65; P=0.0209) and in OPUS-1 (effect, 0.24; 95% CI, 0.10–0.38; P=0.0007). Among more symptomatic subjects (baseline EDS [VAS] ≥40, prior artificial tear use), lifitegrast improved EDS (VAS) versus placebo in a post hoc sub-set analysis of OPUS-1 (lifitegrast n=63, placebo n=67; effect, 13.34; 95% CI 2.35–24.33; nominal P=0.0178) and in the full trial population of OPUS-2 (treatment effect, 12.61; 95% CI, 8.51–16.70; P<0.0001). Across the trials, most TEAEs were mild/moderate in severity, and no serious ocular TEAEs were reported.

Conclusions:

Across 3 randomized controlled trials, lifitegrast improved signs of DED in participants with mild-to-moderate baseline symptoms in 2 studies, and reduced symptoms in participants with moderate-to-severe baseline symptoms in 2 studies. Lifitegrast appeared to be well tolerated in these studies with no serious ocular TEAEs. Based on the overall findings from these clinical trials, lifitegrast has shown promise as a new treatment option for signs and symptoms of DED.

Financial Disclosure:

One or more of the authors is employed by a competing company, One or more of the authors travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, One or more of the authors research is funded, fully or partially, by a competing company, One or more of the authors research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, One or more of the authors receives consulting fees, retainer, or contract payments from a competing company, One or more of the authors receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented

Back to Poster listing