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.

“Having a new entry into the arena will also raise awareness of dry eye, and that awareness will result in more patients recognizing they have the condition and more practitioners thinking about dry eye as not just a nuisance condition, but something they can actively manage,” she said. “It will improve patient care and move efforts to more early detection and prevention of dry eye.”

Nichols noted that the studies on lifitegrast involved patients with the “fairly traditional type of dry eye,” those with signs and symptoms of dry eye who had been using artificial tears without considerable success.

“But that doesn’t mean it wouldn’t work on other types of patients,” she said.

“The projections of the number of patients with dry eye are astronomical,” Nichols added. “When you consider that most of these patients are undiagnosed, it creates a wonderful opportunity to recognize dry eye as a disease with a progressive nature to it that can be managed.”

This is Shire’s first approval in ophthalmics, Robert Dempsey, Shire vice president and head of ophthalmics, said in a prepared statement.

“This is also a major milestone for the eye care professionals treating this often chronic condition who have not had a new, FDA-approved treatment option in more than a decade,” he said.

Shire said it expects to launch Xiidra in the U.S. in the third quarter of 2016. – by Nancy Hemphill, ELS, FAAO

Disclosure: Nichols reports she has been a consultant for Allergan, InSite Vision, Kala Pharmaceuticals, Shire and ScienceBased Health. She has done research studies for Allergan, Bruder, Kala, Shire, TearScience and Vistakon.