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OP0237 Lifitegrast ophthalmic solution 5.0% for treatment of dry eye disease: combined evidence from 5 randomized controlled trials
  1. C Baudouin1,
  2. M Darvish-Zargar2,
  3. EJ Holland3,
  4. CC Chan4,
  5. KK Nichols5,
  6. J Tauber6,
  7. A Raychaudhuri7,
  8. M Roy7,
  9. A Shojaei7
  1. 1Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts, Paris, France
  2. 2McGill University, Montreal, Canada
  3. 3Cincinnati Eye Institute, Edgewood, United States
  4. 4University of Toronto, Toronto, Canada
  5. 5University of Alabama School of Optometry, Birmingham
  6. 6Tauber Eye Center, Kansas City
  7. 7Shire, Lexington, United States


Background Dry eye disease (DED) is a multifactorial disease of the tear film and ocular surface, characterized by ocular discomfort and visual disturbance.1 DED is associated with a number of systemic autoimmune diseases, particularly rheumatoid arthritis and Sjögren's syndrome.2,3 Lifitegrast is a lymphocyte function-associated antigen-1 (LFA-1) antagonist that inhibits T-cell–mediated inflammation (an underlying factor in DED) and is approved in the US for the treatment of signs and symptoms of DED (lifitegrast ophthalmic solution 5.0%, Xiidra®).

Objectives To evaluate the combined evidence from 5 clinical trials of lifitegrast ophthalmic solution 5.0% (LIF) in subjects with dry eye disease (DED).

Methods Adults with DED were randomized to LIF or placebo (PBO) in 5 randomized, double-masked, placebo-controlled trials: 4 12-week efficacy/safety studies (phase 2, LIF n=58, PBO n=58; phase 3 trials: OPUS-1, LIF n=293, PBO n=295; OPUS-2, LIF n=358, PBO n=360; OPUS-3, LIF n=355, PBO n=356), and a 1-year safety study (SONATA, LIF n=220, PBO n=111). Individuals with secondary Sjögren's syndrome associated with autoimmune disease (eg, rheumatoid arthritis, systemic lupus erythematosus) were eligible to participate if they were not immunodeficient/immunosuppressed, not taking steroids, and met all other inclusion and exclusion criteria. Change from baseline to day 84 in DED signs and symptoms was evaluated across the 12-week studies. Key measures were inferior corneal staining score (ICSS; 0–4 scale), eye dryness score (EDS; visual analogue scale [VAS], 0–100 scale), and visual-related function subscale of a symptom scale (0–4 scale). Pooled safety data (LIF n=1287, PBO n=1177) from all 5 trials were also analyzed.

Results LIF improved ICSS versus PBO in the phase 2 study (secondary endpoint; treatment effect 0.35, nominal P=0.0209), OPUS-1 (co-primary; 0.24, P=0.0007), and OPUS-3 (ad hoc; 0.17, nominal P=0.0144). LIF reduced EDS (VAS) versus PBO in OPUS-2 (co-primary; 12.61, P<0.0001) and OPUS-3 (primary; 7.16, P=0.0007). The OPUS-1 co-primary symptom endpoint of visual-related function subscale, and the OPUS-2 co-primary sign endpoint of ICSS, did not achieve statistical significance. In the pooled safety analysis, total exposure was 415.65 person-years for LIF, and 332.15 person-years for PBO. Adverse events were mostly mild or moderate in severity. There were no serious ocular treatment-emergent adverse events (TEAEs) and withdrawals due to TEAEs were infrequent (LIF, 7.0%; PBO, 2.6%).

Conclusions LIF improved signs and symptoms of DED in adults with DED and appeared to be well tolerated with no serious ocular TEAEs reported.


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  2. Fujita M et al. Am J Ophthalmol. 2005;140:808–13.

  3. Patel SJ, Lundy DC. Am Fam Physician. 2002;66:991–8.


Acknowledgements This study was sponsored by SARcode Bioscience (now a wholly owned subsidiary of Shire PLC) and Shire Development LLC.

Disclosure of Interest C. Baudouin Consultant for: Alcon Laboratories, Inc., Allergan, Dompé, Horus Pharma, Santen Inc., Thea Pharmaceuticals, M. Darvish-Zargar Consultant for: Allergan, Novartis, Abbott Medical Optics, E. Holland Grant/research support from: Alcon Laboratories Inc., Allergan, Mati Therapeutics, Omeros, PRN, Senju Pharaceuticals, Consultant for: Alcon Laboratories Inc., Allergan, Bausch & Lomb, Kala Pharmaceuticals, Mati Therapeutics, Omeros, PRN, RPS, Senju Pharaceuticals, Shire/SARcode, TearLab, TearScience, Speakers bureau: Alcon Laboratories Inc., Allergan, Bausch & Lomb, Omeros, Senju Pharaceuticals, Shire/SARcode, TearScience, C. Chan Grant/research support from: Allergan, Bausch and Lomb, TearLab, Consultant for: Allergan, Bausch & Lomb, Alcon Labs Inc., TearScience, K. Nichols Grant/research support from: Kala Pharmaceuticals, Shire PLC, TearScience, Vistakon, Consultant for: Allergan, InSite Vision Inc., Kala Pharmaceuticals, Parion Sciences, Santen, ScienceBased Health, Shire PLC/SARcode, J. Tauber Consultant for: Allergan, Bausch & Lomb, Shire PLC, Senju Pharaceuticals, Speakers bureau: Shire/SARcode, A. Raychaudhuri Employee of: Shire PLC (at the time of the study), M. Roy Employee of: Shire PLC, A. Shojaei Employee of: Shire PLC

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