Lifitegrast efficacy and safety for treatment of dry eye disease: overview of 5 randomised controlled trials

Session Details

Session Title: Presented Poster Session: Cornea: Medical

Venue: Poster Village: Pod 2

First Author: : M.Morral SPAIN

Co Author(s): :    J. Benitez-del-Castillo   E. Donnenfeld   C. Baudouin   V. Perez   E. Holland   K. Nichols   P. Karpecki   J. Tauber   M. Hamdani

Abstract Details

Purpose:

Lifitegrast, a lymphocyte function-associated antigen-1 (LFA-1) antagonist, is approved in the US for treatment of signs and symptoms of dry eye disease (DED). Efficacy and safety of lifitegrast 5.0% ophthalmic solution for treatment of DED were evaluated in four 84-day trials, and long-term safety and tolerability were evaluated in a one-year study. A post-hoc responder analysis of two phase 3 trials assessed the percentage of subjects who achieved pre-defined reductions in eye dryness score (EDS). Here we report the combined evidence from all five clinical trials and the responder analysis.

Setting:

Five randomized, double-masked, placebo-controlled trials were conducted at multiple sites in the US: four 84-day efficacy and safety trials (phase 2, lifitegrast n=58, placebo, n=58; phase 3 trials: OPUS-1, n=293, n=295; OPUS-2, n=358, n=360; OPUS-3, n=355, n=356) and a 1-year safety study (SONATA, lifitegrast n=220, placebo n=111).

Methods:

Inclusion criteria were: adults (≥18 years) with DED, EDS ≥40 (visual analogue scale [VAS], 0–100), corneal staining score ≥2.0 (0–4). For efficacy, changes from baseline to day-84 in symptoms (EDS) and signs (inferior corneal staining score [ICSS], 0–4) were evaluated. For the responder analysis, we evaluated the percentage of subjects who achieved EDS reduction of ≥10, ≥15, ≥20 points or ≥30%, ≥50%, ≥70% (change from baseline to days 14, 42 and 84) in the OPUS-2 and OPUS-3 trials. For safety evaluation, pooled safety data (lifitegrast n=1287; placebo, n=1177) from all 5 trials was analyzed.

Results:

Lifitegrast significantly improved EDS versus placebo in three trials: OPUS-1 (treatment effect [TE], 4.7, P=0.0311), OPUS-2 (TE, 12.3, P<0.0001), and OPUS-3 (TE, 7.5, P=0.0003). Significant improvement was observed for ICSS in phase 2 (TE, 0.25, P=0.0498), OPUS-1 (TE, 0.23, P=0.0007), and OPUS-3 (TE, 0.17, nominal P=0.0135), but not in OPUS-2. A higher percentage of subjects achieved ≥30% EDS reduction with lifitegrast versus placebo: OPUS-2, day-14, 47.5% versus 30.6%; day-42, 59.8%, 41.1%; day-84, 68.7%, 48.9%; OPUS-3, day-14, 52.6%, 35.1%; day-42, 67.1%, 49.0%; day-84, 74.2%, 60.1% (all nominal P<0.0001). Lifitegrast was well tolerated with no serious ocular adverse events.

Conclusions:

Lifitegrast significantly improved symptoms of DED in three of the four 84-day trials. Improvement in EDS was observed as early as day-14 in the OPUS-2 and OPUS-3 trials. Improvement of DED signs was also observed in three of the trials. The safety data indicate that the drug is well tolerated. Across five trials lifitegrast improved signs and symptoms of DED and was well tolerated.

Financial Disclosure:

has significant investment interest in a company producing, developing or supplying product or procedure presented,. travel has been funded, fully or partially, by a competing company, research is funded, fully or partially, by a competing company, research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, receives consulting fees, retainer, or contract payments from a competing company, ... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, is employed by a for-profit company with an interest in the subject of the presentation, has significant investment interest in a competing company