Shire dry-eye disease drug meets primary endpoint in Phase III trial; plans US FDA resubmission
Ireland-headquartered Shire (LSE: SHP) said its drug to treat dry-eye disease lifitegrast met the primary endpoint in late stage trials.
Flemming Ornskov, chief executive, said: "We're delighted with the positive top-line findings. If approved...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."
The company said it plans to use the data for reapplication with the US Food and Drug Association in the first quarter of 2016 seeking clearance to market lifitegrast to treat signs and symptoms of dry-eye disease.
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