Three clinical trials - OPUS-1, OPUS-2 and SONATA - currently make up the phase 3 clinical development program for LIFITEGRAST. OPUS-1, a safety and efficacy study, concluded in 2012. In this study the co-primary endpoint of reducing signs of dry eye was met. Although the co-primary endpoint of reducing symptoms was not achieved, this study was the basis of a positive meeting with the FDA and for the continuation of the phase 3 clinical program, including OPUS-2, a safety and efficacy study of both signs and symptoms of dry eye disease, which is currently ongoing. In addition to the OPUS-2 clinical efficacy study, SONATA, a randomized, placebo-controlled safety study is also ongoing. Shire is excited about the potential contribution of this product to the treatment options for patients with dry eye disease.
About Dry Eye Disease
Dry eye disease varies in severity and etiology, and symptoms most commonly manifest as ocular discomfort, eye dryness, and tear film instability due to decreased quality or quantity of tears. A major contributing factor towards the development of dry eye is inflammation caused by T-cell infiltration, proliferation and inflammatory cytokine production that can lead to reduction in tear film quality and ocular surface damage.
Some 25 million people are affected in the United States. This number is expected to grow substantially in the next decade due to an aging population, a contributor to higher rates of dry eye disease.
NOTES TO EDITORS
Shire enables people with life-altering conditions to lead better lives.
Through our deep understanding of patients' needs, we develop and provide healthcare in the areas of:
|SOURCE Shire plc|
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