Shire receives FDA complete response letter for lifitegrast NDA and plans to respond with OPUS-3 trial

Topline results from OPUS-3 Trial expected before year-end.

Shire has announced that the FDA has 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 III 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, 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 US living with the symptoms of this chronic and progressive disease,” said Philip J. Vickers, Head of R&D, Shire.

OPUS-3, a randomized, double-masked, 12-week Phase III study enrolled 711 patients to evaluate the efficacy and safety of lifitegrast. The clinical trial’s primary endpoint is patient-reported symptom improvement as measured by the Eye Dryness Score EDS scale.

The new drug application for lifitegrast included data from four randomized, controlled clinical trials with more than 1800 patients. These include one Phase II study, two Phase III efficacy and safety studies (OPUS-1 and OPUS-2), and one long-term Phase III safety study (SONATA).

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