Shire files for approval of dry eye disease therapy in Europe

Shire has applied for European regulatory approval of a new treatment for dry eye disease.

The marketing authorisation application for lifitegrast has been validated by the UK, which is acting as the reference member state for the European Commission's approval process.

If approved, lifitegrast would become the first and only treatment in a new class of drugs called LFA-1 antagonists, designed to address the signs and symptoms of dry eye disease in adults.

This application is supported by the largest development programme to date for an investigational-stage dry eye disease candidate, consisting of five clinical trials with more than 2,500 patients.

Dr Howard Mayer, head of clinical development for Shire, said: "This submission is another important milestone for lifitegrast and the millions of patients living with dry eye disease, which can impact a person's vision-related quality of life, affecting daily activities such as reading and using computers."

The disease is characterised by eye dryness and overall eye discomfort, as well as stinging, burning and fluctuating blurry vision. It is one of the most common conditions seen by ophthalmologists and eye care practitioners worldwide.

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