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CLINICAL RESEARCH C

2017 CAO Congress Poster Session Abstracts

Lifitegrast 5.0% in Patients with Dry Eye Disease: A Pooled Analysis

E Bitton, OD, MSc1; P Karpecki, OD2; C Matossian, MD3; K Sall, MD4; A Raychaudhuri, PhD5;
M Roy, OD, MPH5; A Shojaei, PharmD, PhD5
1Ecole d’optométrie, Université de Montréal, Montréal, Canada; 2Kentucky Eye Institute, Lexington,
KY ; 3Matossian Eye Associates, Doylestown, PA; 4Sall Research Medical Center, Artesia, CA; 5Shire,
Lexington, MA.

PURPOSE
Lifitegrast is an integrin (transmembrane receptor) antagonist that specifically blocks the interaction of cell sur-
face proteins (LFA-1 and ICAM-1), thus inhibiting release of inflammatory cytokines involved in the inflammatory
pathway of dry eye disease (DED). Data from 2 phase 3, multicenter, randomized-controlled trials (OPUS-2 and
OPUS-3) of similar design, were pooled to characterize the effect of lifitegrast ophthalmic solution 5.0% (LIF) on
DED symptoms and signs.

METHODS
Adults with DED (Schirmer 1-10 mm, eye dryness score [EDS, visual analogue scale 0–100; 0=no discomfort,
100=maximal discomfort] =40, corneal staining score =2.0), and a history of recent artificial tear use were random-
ized 1:1 to receive LIF or placebo (PBO) bid for 84 days. The change from baseline in symptoms (EDS) and signs
(Schirmer, ocular surface staining and conjunctival redness score) was evaluated at day 14, 42 and 84.

R E S U LT S
1429 subjects were included (713 LIF; 716 PBO) with an overall mean age of 58.7 yrs (1087F:342M). Subjects using
LIF experienced significantly greater improvement from baseline in EDS vs PBO at days 14 (treatment effect [TE],
7.23; 95% CI, 4.71–9.76; P<0.0001), 42 (TE, 9.75; 95% CI, 6.99–12.50; P<0.0001) and 84 (TE, 9.92; 95% CI, 7.01–12.83;
P<0.0001). In OPUS-2, sign measures improved from baseline in both groups over time but were not statistically
different between groups. In OPUS-3, inferior corneal staining score demonstrated a nominally significant improve-
ment in favor of LIF (TE 0.17, nominal P=0.0144). The most common adverse events (=5% in either group) were
instillation site irritation (LIF 13.0%, PBO 2.2%), instillation site reaction (LIF 9.8%, PBO 3.2%) and dysgeusia (LIF
14.5%, PBO 0.3%).

CONCLUSION
In this pooled analysis of 2 trials, LIF significantly improved symptoms of eye dryness, as measured by EDS,
vs PBO in subjects with DED as early as day 14. Signs were improved vs PBO in 1 of the 2 trials. LIF appeared
well tolerated.

CONFLICT OF INTEREST DISCLOSURE
• This study was funded by Shire. The authors thank Nasser Malik, PhD, of Excel Scientific Solutions, who
provided medical writing assistance funded by Shire. The material presented in this poster is adapted from
Dr. Matossian’s poster presentation at the 2016 meeting of the American Academy of Ophthalmology.

• Etty Bitton has been a consultant and/or received honoraria from Akorn, ALCON, Allergan, CooperVision,
Labtician, JOBSON publishing, OPTICIAN journal, Orimed, Shire, TBWA World Health. Dr. Bitton has
received research funding from ALCON Canada, Allergan Canada, Canadian Optometric Educational Trust
Fund (COETF), FDERC, I-med Pharma Inc.

• Paul Karpecki has been a consultant for Akorn, Alcon Laboratories, Allergan, AMO, Bausch & Lomb/
Valeant, Beaver-Visitec, BioTissue, Bruder Healthcare, Focus Laboratories, OcuSoft, Paragon Bioteck,
PRN, Shire/SARcode, ScienceBased Health, TearLab, and TearScience. Dr Karpecki has received
research funding from Allergan, Bausch & Lomb, Fera Pharmaceuticals, Shire/SARcode, and Tear Film
Innovations.

CANADIAN JOURNAL of OPTOMETRY | REVUE CANADIENNE D’OPTOMÉTRIE VOL. 79 NO. 2 27