Lifitegrast (Xiidra) is the first prescription therapy for dry eye disease approved by the FDA in 13 years. Shire says it will be available in the third quarter of 2016.
“I believe lifitegrast will be an effective treatment,” said study investigator Eric D. Donnenfeld, MD. “This eye drop is an important addition to the dry eye treatment armamentarium. However, we need to conduct studies to evaluate its effectiveness and where it fits in dry eye therapy.”
Since the launch of Restasis (0.05% cyclosporine ophthalmic emulsion, Allergan) in 2003, several companies have filed applications for similar dry eye dugs, including anakinra, bromfenac, diquafosol, ecabet sodium, isunakinra, rebamipide, tavilermide and tofacitinib. None won U.S. approval, though diquafosol is approved in Japan.
Approval of lifitegrast is based on results from 4 prospective, placebo-controlled studies showing that patients treated twice daily (approximately 12 hours apart) experienced a significant reduction in eye dryness based on a patient-reported eye dryness score. In 2 of the 4 studies, improvement was reported as early as 2 weeks. In 3 of the 4 studies, treated patients showed a significant reduction in dry eye signs at 12 weeks, based on inferior corneal staining scores.
After 1 year, 53.6% of patients reported adverse events, yet most were mild to moderate, and only 12% discontinued the medication. The most common side effects were mild burning at the instillation site and change in taste (dysgeusia), followed by reduced visual acuity and dry eye.
Treated patients decreased artificial tear use, with 18% requiring eye drops after 1 year, compared with 33% in the control group. Comfort after application was rated highly, with an average score of 2 out of 10, with 0 being the most comfortable.
Research shows that T-cells bind with receptors on the ocular surface due to the presence of a signaling transmembrane protein known as intercellular adhesion molecule (ICAM-1). ICAM-1 has been shown to be over-expressed in corneal and conjunctival tissues in patients with dry eye disease. T-cells bind with ICAM-1 on the ocular surface by virtue of a specific integrin, lymphocyte function-associated antigen (LFA)-1.
Lifitegrast was engineered to interfere with the binding of LFA-1 to ICAM-1. When LFA-1 is blocked the affinity for ICAM-1 is disrupted, and the T-cell is unable to adhere to the tissue surface, preventing the pathological process.