Shire submits dry eye drug in Europe

The disease, which is most commonly associated with eye dryness and overall eye discomfort, as well as stinging, burning, and fluctuating blurry vision, is a common condition across the globe.

Lifitegrast is a lymphocyte function-associated antigen-1 (LFA-1) antagonist that blocks the interaction of LFA-1 with its cognate ligand intercellular adhesion molecule-1, which plays a prominent role in inflammation of the surface of the eye.

Shire says the drug’s marketing application is backed by data from five clinical trials with more than 2,500 patients. In four safety and efficacy studies, lifitegrast improved symptoms as measured by patient reported eye dryness score, and in three of the four studies it improved the objective signs of dry eye disease.

A long-term safety study in which patients were randomised to receive either lifitegrast (n=220) or placebo (n=111) over 360 days also found that the drug was generally well-tolerated with no serious treatment-emergent ocular adverse events.

Shire acquired lifitegrast through its $160-million take-over of US group SARcode Bioscience in 2013, and is expecting peak sales of more than $1 billion if it makes it to market.

The drug was approved by the US Food and Drug Administration under the brand name Xiidra for the treatment of signs and symptoms of dry eye disease in July 2016, having initially been rejected by the regulator the previous October with a request for more data.