FDA Approves Lifitegrast (Xiidra) for Dry Eye

Megan Brooks


July 12, 2016

The US Food and Drug Administration (FDA) has approved lifitegrast ophthalmic solution (Xiidra, Shire) for the treatment of signs and symptoms of dry eye disease.

Lifitegrast is the first lymphocyte function–associated antigen 1 antagonist approved by the FDA for dry eye disease. It is the only prescription eyedrop indicated for the treatment of both signs and symptoms of dry eye disease, and it is the first treatment to be approved for dry eye disease in more than a decade, Shire notes in a news release announcing approval.

"Normal tear production is needed for clear vision and eye health. This approval will provide a new treatment option for patients with dry eye disease," Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in an FDA statement.

Dry eye disease affects roughly 5% of adults aged 30 to 40 years and 10% to 15% of those older than 65 years. It is more common in women. Severe, untreated dry eye can lead to pain, ulcers, or corneal scarring.

The safety and efficacy of lifitegrast were assessed in more than 1100 adults with dry eye disease (76% women) in four randomized controlled studies in which patients received either lifitegrast eyedrops or placebo eyedrops twice daily 12 hours apart for 12 weeks.

According to the company, in all four studies, a larger reduction in eye dryness score (EDS) was observed with lifitegrast ophthalmic solution at 6 and 12 weeks. In two of the studies, an improvement in EDS was seen with lifitegrast at 2 weeks. At 12 weeks, a larger reduction in inferior corneal staining score favoring lifitegrast was seen in three of the four studies.

The most common adverse reactions reported in 5% to 25% of patients were instillation site irritation, altered taste sensation (dysgeusia), and reduced visual acuity.

The safety and efficacy of lifitegrast in children younger than 17 years have not been studied, the FDA notes. Full prescribing information is available here.

Shire said it expects to launch lifitegrast eyedrops in the next 2 months.

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