Shire Receives FDA CRL for Lifitegrast NDA and Plans to Respond with OPUS-3 Trial

Shire plc

announced Friday, that the U.S. Food and Drug Administration (FDA) requested an additional clinical study as part of a complete response letter (CRL) to the company's new drug application for lifitegrast for the signs and symptoms of dry eye disease in adults. Shire has recently completed a Phase 3 study of lifitegrast, OPUS-3, that is expected to be the basis of Shire's response to the CRL. The FDA also requested more information related to product quality, which Shire will address in the CRL response. Topline results of OPUS-3 are expected before year-end, and, and if positive, the company plans to submit these data as part of a resubmission to the FDA during the first quarter of 2016. "We will work quickly to address the FDA's requests related to lifitegrast, as we are committed to delivering a new prescription treatment option for the 29 million adults in the U.S. living with the symptoms of this chronic and progressive disease," said Philip J. Vickers, Ph.D., Head of Research and Development, Shire. Symptoms of dry eye disease vary by patient, but typically may