FDA Approves Xiidra (Lifitegrast) for Dry Eyes Save

MedScape has reported that 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 (LFA-1) agonist approved by the FDA for dry eye disease. The drug binds to the integrin LFA-1 and blocks the interaction of LFA-1 with its ligand intercellular adhesion molecule-1 (ICAM-1). ICAM-1 is overexpressed in corneal and conjunctival tissues in 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. 

Dry eye disease affects 16 million Americans or 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. While patients with secondary Sjogrens's syndrome were included in their trials, primary Sjogren's was not. Hence the drug is approved for dry eyes, but not specifically for Sjogren's.

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.