Shire receives FDA complete response letter for lifitegrast NDA

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.

Shire head of research and development Philip Vickers said: "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."

Symptoms of dry eye disease vary by patient, but typically may include eye dryness, overall eye discomfort, stinging, burning, a gritty feeling and episodes of blurred vision.

OPUS-3, a randomized, double-masked, 12-week Phase 3 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 1,800 patients. These include one Phase 2 study, two Phase 3 efficacy and safety studies (OPUS-1 and OPUS-2), and one long-term Phase 3 safety study (SONATA).