Shire planning to respond to FDA with OPUS-3 Trial
In an announcement Shire plc said that the company has been asked by the US Food and Drug Administration (FDA) for an additional clinical study in a complete response letter (CRL) to its new drug application for lifitegrast. The drug is used for the signs and symptoms of dry eye disease in adults.
Recently, the company has completed a Phase 3 study of lifitegrast, OPUS-3, that will likely be the basis of response of Shire to the CRL. The FDA has also asked for more information about the product quality, which Shire is going to address in the CRL response.
Before the end of this year, the Topline results of OPUS-3 are expected. It they come positive then the company will submit the data to the FDA as part of a resubmission in the first quarter of 2016.
Philip J. Vickers, Ph.D., Head of Research and Development, Shire, said, “We will work quickly to address the FDA's requests related to lifitegrast, as we are committed to delivering new prescription treatment option for the 29 million adults in the US living with symptoms of this chronic and progressive disease”.
Different patients have different symptoms of dry eye disease, but they particularly include eye dryness, overall eye discomfort, stinging, burning, a gritty feeling and moments of blurred vision.
During the study OPUS-3, which is a randomized, double-masked, 12-week Phase 3 study, 711 patients were enrolled for the evaluation of the efficacy and safety of lifitegrast. The primary endpoint of the clinical trial will beimprovement reported by patient as measured by the Eye Dryness Score EDS scale.
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