Shire submits European marketing application for dry-eye drug

Shire's application for Europe-wide marketing of its lifitegrast dry-eye disease drug has been approved by the UK.

As part of the EU's decentralised procedure (DCP), the UK as a reference member state has validated Shire's Marketing Authorization Application for lifitegrast to be sold in the UK, Germany, the Netherlands, France, Italy, Portugal, Spain and Greece and Scandinavia.

"If approved, lifitegrast would be the first and only treatment in a new class of drugs to address the signs and symptoms of dry eye disease in adults in Europe," the company said.

Dry eye disease, or dry eye syndrome, is a common condition that occurs when the eyes don't make enough tears, or the tears evaporate too quickly.

Shire, which pointed to research that indicates the syndrome ranges from 5-50% in adults globally, has carried out five clinical trials of the drug with more than 2,500 patients.

“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,” said Howard Mayer, head of clinical development, R&D.

“Shire is committed to continued innovation in ophthalmics, where there are opportunities to address unmet need and improve the lives of patients.”