By William Elliott, MD, FACP, and James Chan, PharmD, PhD
Dr. Elliott is Medical Director, Pharmacy, Northern California Kaiser Permanente, and Assistant Clinical Professor of Medicine, University of California, San Francisco. Dr. Chan is Pharmacy Quality and Outcomes Manager, Kaiser Permanente, Oakland, CA.
Drs. Elliott and Chan report no financial relationships relevant to this field of study.
The FDA has approved the first eye drop for the treatment of dry eye disease. Lifitegrast is a selective lymphocyte-function-associated antigen-1 (LFA-1) antagonist. It is marketed as Xiidra.
Lifitegrast is approved for the treatment of the signs and symptoms of dry eye disease.1
The recommended dose is one drop in each eye twice daily approximately 12 hours apart.1 Lifitegrast is available in a 5% solution in single-use preservative-free units.
Lifitegrast is the first drug and the first in class approved for this indication.
Most frequently reported adverse events (vs. vehicle) were instillation site irritation (15% vs. 3%), dysgeusia (15% vs. 0.3%), and decreased visual acuity (5% vs. 4%).1,2
Lifitegrast is believed to inhibit ocular inflammation in dry eye disease.3 Efficacy and safety of lifitegrast was evaluated in four randomized, double-masked, vehicle-controlled, 12-week studies in adult subjects with dry eye disease.1-4 The four studies were similar in design. Two included both signs and symptoms as primary endpoints and the other two used signs or symptoms as the primary endpoint. Symptoms were assessed with the eye dryness score (EDS) using a visual analogy scale from 0 to 100 (0 = no discomfort and 100 = maximal discomfort) or 4-point visual-related function subscale score of the Ocular Surface Disease Index. Signs of dry eye disease were assessed with the inferior fluorescein corneal staining score (ICSS) with 0 = no staining, 1 = few/rare punctate lesions, 2 = discrete and countable lesion, 3 = lesions too numerous to count but not coalescent, 4 = coalescent. Results were assessed at days 14, 42, and 84. In the two studies with both signs and symptoms as endpoints, lifitegrast showed significant improvement for signs or symptoms over the vehicle, but not both. In the other two studies with a single endpoint, lifitegrast was better than vehicle in each study. In the most effective studies, the difference observed between lifitegrast and vehicle was 18% for symptoms and 13% for signs.
Dry eye disease affects about 20 million people in the United States.5 It is characterized by ocular discomfort, decreased tear quality or quantity, and chronic ocular inflammation. This condition frequently is associated with increasing age and most common in post-menopausal women.2 The most common treatment is artificial tears. Cyclosporine increases tear production and is approved for the treatment of keratoconjunctivitis sicca. Lifitegrast is the first drug approved specifically for dry eyes. The wholesale cost of lifitegrast is $426.73 for 60 single-use units.
- Xiidra Prescribing Information. Shire US, Inc. July 2016.
- FDA. Xiidra (lifitegrast ophthalmic solution). Available at: . Accessed Aug. 13, 2016.
- Semba CP, Gadek TR. Development of lifitegrast: A novel T-cell inhibitor for the treatment of dry eye disease. Clin Ophthalmol 2016;10:1083-1094.
- Tauber J, Karpecki P, Latkany R, et al. Lifitegrast ophthalmic solution 5.0% versus placebo for treatment of dry eye disease: Results of the randomized phase III OPUS-2 study. Ophthalmology 2015;122:2423-2431.
- FDA News Release. FDA approves new medication for dry eye disease. Available at: . Accessed Aug. 13, 2016.