FDA approves lifitegrast for signs, symptoms of dry eye
The FDA announced today that it approved lifitegrast for treating the signs and symptoms of dry eye disease in adults on July 11.
Xiidra (lifitegrast ophthalmic solution 5%, Shire) is the first medication in a new class of drugs, called lymphocyte function-associated antigen 1 agonists, approved for dry eye disease, the FDA said in a press release.
This twice-daily treatment was assessed in four placebo-controlled 12-week trials involving 1,181 patients, of whom 1,067 received lifitegrast 5%, according to a press release from Shire. Patients were evaluated at baseline, week 2, week 6 and week 12 for dry eye symptoms and signs.
Shire reported that a larger reduction in eye dryness score was observed with Xiidra at weeks 6 and 12 in all studies. In two studies, improvement was seen at 2 weeks. A larger reduction in intracorneal staining score was seen with Xiidra in three studies at week 12. The most commonly reported adverse reactions in 5% to 25% of patients were irritation at instillation site, altered taste sensation and reduced visual acuity.
Kelly K. Nichols , OD, MPH, PhD, FAAO, told Primary Care Optometry News that the availability of lifitegrast will have two benefits: Patients will be able to be successfully managed for both signs and symptoms of dry eye, and the opportunity now exists to see how the agent works with other therapeutics.
“No studies have been done to show that yet, and there will be a flurry of research to see how it works in the environment of dry eye as we move forward,” she said.
Nichols is dean of the University of Alabama at Birmingham School of Optometry and has also conducted research studies for Shire…….
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