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news.Shire has secured approval from the US Food and Drug Administration (FDA) for its Xiidra (lifitegrast ophthalmic solution) to treat signs and symptoms of dry eye disease.
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Xiidra is the first medication in a new class of drugs, dubbed lymphocyte function-associated antigen 1 (LFA-1) antagonist, approved by the US regulator for dry eye disease.
It is dosed twice a day, about 12 hours apart, in each eye.
The safety and efficacy of Xiidra was evaluated in 1,181 patients, in four separate, randomized, controlled studies.
The trials included patients 19–97 years of age, of which 76% were female.
Patients were randomized equally to receive either Xiidra eyedrops or placebo eyedrops, which were used twice a day for twelve weeks.
Under the studies, groups treated with Xiidra demonstrated more improvement in both the signs and the symptoms of eye dryness, when compared to placebo.
Eye irritation, discomfort or blurred vision and an unusual taste sensation were the most common side effects of Xiidra.
Shire CEO Flemming Ornskov said: “The approval of Xiidra marks a new day in treatment options for patients with dry eye disease, with the only prescription eye drop approved in the U.S. specifically to treat both the signs and symptoms of the condition.
“As Shire’s first FDA-approved medicine in ophthalmics, this significant milestone advances our goal of becoming the global leader in this category, where there are unmet patient needs.”
The company expects to launch Xiidra in the US in the third quarter of this year.