15 August 2017 - Lifitegrast, if approved, would be the first and only new class treatment to address the signs and symptoms of dry eye disease in adults in Europe.
Shire announces that the marketing authorisation application for lifitegrast, submitted on 7 August 2017, has been validated by the UK as the Reference Member State involved in the decentralised procedure . 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.
Shire’s application 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.