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An estimated 16 million adults in the U.S. are diagnosed with dry-eye disease. Xiidra is the first FDA-approved prescription eye drop indicated for the treatment of both signs, such as corneal straining (abrasions on the cornea), and symptoms of this condition, which include eye dryness, discomfort and stinging, the company said.
"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 Shire CEO Flemming Ornskov in a press release.
Shire's drug was initially rejected by the FDA in October, when the company was asked for an additional clinical study, which it supplied.
The company expects to launch the drug during the current quarter.
Shire's U.S. stock has fallen about 5 percent this year.
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