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Medicines licensing

FDA approves drug for dry eye disease

A new class of drug is being made available in the United States to treat the signs and symptoms of dry eye disease, the US Food and Drug Administration (FDA) has announced.

The FDA, which governs medicines safety, has approved the use of lifitegrast ophthalmic solution, branded as Xiidra by Shire US. Lifitegrast is a lymphocyte function-associated antigen 1 (LFA-1) agonist.

The decision was based on the results of four separate randomised controlled trials involving more than 1,000 patients, in which participants were randomised equally to receive either lifitegrast or placebo eye drops, administered twice a day for 12 weeks. Patients treated with lifitegrast showed greater improvement in both the signs and the symptoms of eye dryness compared with patients in the placebo group.

The most commonly reported side effects of the new drug include eye irritation, discomfort or blurred vision and an unusual taste sensation.

Dry eye disease occurs when the eye fails to produce an adequate volume of tears or when the tears are not of the correct consistency. If severe and left untreated, the condition can lead to pain, ulcers or scars in the cornea. Symptoms can make it more difficult to use a computer or read for a long time and can make dry environments, such as the inside of an airplane, more uncomfortable.

Incidence of dry eye disease increases with age; it does not routinely appear in children aged under 17 years.

Shire expects to launch Xiidra in the United States in the third quarter of 2016.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20201426

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