Global biotechnology company, Shire, has submitted a marketing authorisation application (MAA) for its dry eye treatment, liftegrast, which, if approved, would represent the first and only LFA-1 antagonist drug to treat the signs and symptoms of the disease in adults in Europe.
Dry eye
The MAA is supported by a development programme comprising five clinical trials of 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).
Dry eye disease is a common condition and is usually associated with eye dryness and overall eye discomfort. It can affect quality of life and may have an impact on a person’s daily activities, such as computer use.
“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 Dr 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.”
This MAA has been submitted via the decentralised procedure (DCP) to Denmark, Norway, Sweden, Finland, the UK, Germany, the Netherlands, France, Italy, Portugal, Spain and Greece. It has been validated by the UK, which is the reference member state.