12th Jul 2016 09:54
LONDON (Alliance News) - Irish pharmaceuticals company Shire PLC was among the top gainers in the FTSE 100 Tuesday morning, after its key dry eye disease treatment lifitegrast received approval from the US Food & Drug Administration.
The eye drop treatment, branded Xiidra, is expected to be launched in the US in the third quarter of 2016.
Dry eye disease is a chronic disease of the tears and ocular surface which can cause inflammation that could eventually result in damage to the surface of the eye. An estimated 16 million adults in the US are diagnosed with the disease, according to Shire.
Shire said Xiidra is the only prescription eye drop indicated for the treatment of both signs and symptoms of dry eye disease.
The approval was based on safety and efficacy data, including data from four 12-week trials with 1,181 patients. In two of the four studies an improvement in patient reported eye dryness score, which was used as a baseline to assess symptoms, was seen with Xiidra at two weeks.
Edward Holland, a professor of clinical ophthalmology at the University of Cincinnati and a clinical trial investigator for Xiidra, said the clinical programme supporting Xiidra's approval was the "largest for an investigational-stage dry eye disease candidate to date", including more than 2,500 patients.
"As Shire's first FDA-approved medicine in ophthalmics, this significant milestone advances our goal of becoming the global leader in this category, where there are unmet patient needs. We have a robust ophthalmics pipeline, and we look forward to leveraging Xiidra as our entree into the space as we continue to develop additional innovative eye care treatment options," said Flemming Ornskov, Shire's chief executive in a statement.
The approval marks a positive step in Shire's plan to reach product sales of USD20 billion by 2020, along with its recently completed acquisition of Baxalta Inc, as it looks to replace some of its maturing portfolio with new drugs in an effort to avoid a "patent cliff".
The market welcomed the approval, with shares in Shire up 2.8% at 4,953.00 pence Tuesday morning, amid the top gainers in the FTSE 100.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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