Shire submits lifitegrast Marketing Authorization Application for treatment of dry eye disease in Europe

Shire announces that the Marketing Authorization Application (MAA) for lifitegrast, submitted on 07 August 2017, has been validated by the UK as the Reference Member State involved in the Decentralized Procedure (DCP). 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. The disease is most commonly associated with eye dryness and overall eye discomfort, as well as stinging, burning, and fluctuating blurry vision. Dry eye disease may significantly affect quality of life and may impact activities such as reading and using computers. It is one of the most common conditions seen by ophthalmologists and eye care practitioners worldwide.

“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, M.D., 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.”

Shire’s MAA for lifitegrast is supported by the largest development program to date for an investigational-stage dry eye disease candidate, consisting of five clinical trials with more than 2,500 patients. In these studies, the signs of dry eye disease were measured using corneal staining and the symptoms by using patient reported eye dryness score (EDS).