In addition to supporting resubmission of the new drug application (NDA) for Shire PLC's dry-eye disease candidate lifitegrast, the specialty pharma is emphasizing that the just-completed OPUS-3 trial shows that lifitegrast is the first drug ever to demonstrate symptom improvement over consecutive trials in dry eye.
When Shire revealed that it received a complete response letter (CRL) on Oct. 16, it signaled to investors that it would able to respond quickly to the FDA's rejection after...
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