Shire Could Get More Out Of OPUS-3 Than Refiling Lifitegrast

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.

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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