Posters

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