Shire jumps on positive lifitegrast trial results

The study showed the treatment met primary and secondary endpoints, significantly improving patient-reported symptoms of dry eye disease.

The company said it now plans to use this data to resubmit a new drug application for lifitegrast with the US Food and Drug Association in the first quarter of 2016.

Flemming Ornskov, managing director and chief executive officer of Shire, said: “If approved by the FDA, this keeps us on track for a potential US launch next year. We also are planning to use these data, in conjunction with the existing comprehensive clinical data set, for regulatory filings for lifitegrast in other markets outside of the US.

“With these highly statistically significant results, we’re increasingly confident about the potential of lifitegrast and the overall progress we’re making in growing Shire’s presence in ophthalmics.”

Earlier this month, it emerged that the FDA had requested an additional clinical study be carried out on the drug in response to Shire’s new drug application.

At 1147 GMT, Shire shares were up 5.7% at 4,868p.