Shire plc announced on 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, if positive, will be the basis of Shire’s response to the CRL.
“We were disappointed, but will soon have data from the Phase 3 study, OPUS 3,” said Flemming Ornskov, M.D., CEO, Shire.
“OPUS-3 has now been completed and top-line data are expected before the end of the year. If the study is positive, we plan to refile our liftegrast submission in the first quarter of 2016, and will remain on track for the planned lifitegrast launch next year. We are committed to working with FDA to expeditiously provide the evidence required to deliver a new prescription treatment option for the 29 million adults in the US living with the symptoms of this chronic and progressive disease. This is an area of unmet medical need for which there has been no new FDA-approved treatment in over a decade.”
Shire said that the FDA also had requested more information related to product quality, which Shire is confident it can address in the CRL response.
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, said the company.
Also, 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).