Shire dry eye treatment gets FDA approval
pharmafile | July 12, 2016 | News story | Manufacturing and Production, Sales and Marketing | FDA, Shire, dry eye, xiidra
Shire (LSE: SHP) has announced that the US Food and Drug Administration has approved its twice-daily eye drop solution, Xiidra (lifitegrast) for the treatment of the signs and symptoms of dry eye disease in adult patients.
Approximately 16 million US adults have been diagnosed with dry eye disease. It is associated with inflammation that may eventually lead to damage to the surface of the eye.
The company says it is the only prescription eye drop for this indication approved in the US. It expects to launch Xiidra in the third quarter of this year. The drug works by blocking an interaction between molecules that may be overexpressed in corneal and conjunctival tissues in dry eye disease.
In Phase III trials, treatment with Xiidra resulted in improvements in patient reported eye dryness score and inferior corneal staining score. In some studies, these improvements were observed after just two weeks.
Shire CEO, Flemming Ornskov, says: “The approval of Xiidra marks a new day in treatment options for patients with dry eye disease, with the only prescription eye drop approved in the US specifically to treat both the signs and symptoms of the condition.”
Edward Holland, clinical trial investigator for Xiidra, adds: “The clinical program supporting the approval of Xiidra is the largest for an investigational-stage dry eye disease candidate to date, including more than 2,500 patients. The clinical trial program design took into consideration many of the challenges of past dry eye research. It’s exciting to see Xiidra as the first prescription eye drop FDA-approved for both the signs and the symptoms of the condition.”
Sean Murray
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