Shire announced that it has submitted a Marketing Authorization Application (MAA) in the UK for lifitegrast for the treatment of dry eye disease. The application, submitted on August 7, 2017, has been validated by the UK as the Reference Member State involved in the Decentralized Procedure. If approved, lifitegrast, branded as Xiidra in the United States, 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.
“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,” Howard Mayer, MD, Head of Clinical Development, R&D, said in a company news release. “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).
The lifitegrast MAA was submitted via the Decentralized Procedure (DCP) to Denmark, Norway, Sweden, Finland, the UK, Germany, the Netherlands, France, Italy, Portugal, Spain and Greece. The UK is the Reference Member State.