Xiidra, a twice-daily eyedrop solution, is the Dublin-based drugmaker’s first approved medicine in opthalmics.
To test the safety and efficacy of the drug, Shire conducted four different placebo-controlled 12-week trials that involved 1,181 patients.
The signs and symptoms of dry eye disease were recorded at baseline and then two, six and 12 weeks into the study. All four studies showed a larger reduction in eye dryness than placebo at six and 12 weeks.
Company shares rose 4 percent in response to news of the approval. Shire plans to launch Xiidra in the next few months.
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