Shire Submits Marketing Authorization Application in Europe for Lifitegrast for Dry Eye Disease

September 1, 2017: By Jon Swedien

ShireShire has submitted a marketing authorization application (MAA) in Europe for lifitegrast for the treatment of dry eye disease, the Dublin-based company announced Aug. 15.

The application was submitted via the decentralized pathway, with the UK as the reference member state, Shire said.

If approved, lifitegrast would be the first and only treatment in a new class of drugs (LFA-1 antagonist) to address the signs and symptoms of dry eye disease in adults in Europe, Shire said.

The US FDA approved lifitegrast under the brand name Xiidra (lifitegrast ophthalmic solution) 5 percent for dry eye disease in July 2016.

Shire’s MAA for lifitegrast is supported by five clinical trials with more than 2,500 patients, the company said.

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