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    Topical integrin antagonist lifitegrast safely treats dry eye disease

    Study of twice-daily dosing for 1 year yields no unexpected adverse events

    Take-Home Message: Lifitegrast ophthalmic solution 5.0% (Shire Pharmaceuticals) administered twice daily for 1 year appeared safe and well-tolerated with no unexpected adverse events in a study.


    Rockville Centre, NY — Lifitegrast Ophthalmic Solution 5.0% (Shire Pharmaceuticals) seems to be a safe option for treating patients with dry eye. In a study of twice-daily treatment for 1 year, there were no unexpected treatment-related adverse events, and the adverse effects that did occur were similar to those associated with placebo. No patients experienced any serious ocular or non-ocular adverse events associated with the drug, according to Eric Donnenfeld, MD.

    topical integrinLifitegrast is a novel topical integrin antagonist that works by binding to the integrin lymphocyte function-associated antigen-1 (LFA-1), a protein on lymphocytes, and blocking the interaction or adhesion of LFA-1 with its intercellular adhesion molecule-1 (ICAM-1). In patients with dry eye disease, ICAM-1 is over-expressed in the corneal and conjunctival tissues. The interaction of LFA-1 and ICAM-1 promotes inflammation resulting in T-cell activation and migration to the target tissues. Lifitegrast tested in vitro inhibited T-cell adhesion to ICAM-1 expressing cells and inhibited secretion of key inflammatory cytokines and other pro-inflammatory cytokines such as interleukin (IL)-1α, IL-1β, IL-2, IL-4, IL-5, and IL-13, all of which are associated with dry eye disease, according to Dr. Donnenfeld.

    “Lifitigrast is an exciting molecule because it inhibits T-cell mediated inflammation associated with dry eye disease at several different points in the inflammatory cascade with an entirely new mechanism of action,” said Dr. Donnenfeld, who is a founding partner of Ophthalmic Consultants of Long Island and Connecticut, Rockville Centre, NY, clinical professor ophthalmology, New York University Medical Center, New York, and a trustee of Dartmouth Medical School.

    The safety of lifitegrast was evaluated previously in the phase 3 OPUS-1 and OPUS-2 studies, in which the participants instilled the drug twice daily for 84 days. The results showed that the drug was generally well-tolerated in these subjects with dry eye disease. The results of the OPUS-3 efficacy study were release on Oct. 27, 2015, and showed highly significant improvement of dry eye disease for all of the primary and secondary endpoints.

    Dr. Donnenfeld reported on the results of the SONATA Study, a 1-year, multicenter, randomized, placebo-controlled phase 3 study that was carried out in the U.S. Patients were 18 years or older with self-reported dry eye disease, a Schirmer’s test result without anesthesia of 1 mm or higher and 10 mm or less, a corneal staining score of 2.0 or higher, and use of an artificial tear for 6 months or less. Patients were randomly assigned 2 to 1 to lifitegrast (n=221 patients) or placebo (n=111 patients). The patients instilled lifitegrast or placebo twice daily for 1 year.


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