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Shire announced positive topline results from OPUS-3, a Phase 3 efficacy and safety study of lifitegrast for the treatment of signs and symptoms for dry eye disease.
OPUS-3 compared lifitegrast to placebo administered twice daily for 84 days in patients with dry eye, a recent history of artificial tear use within 30 days of study entry and an Eye Dryness Score (EDS) ≥40. The primary endpoint was improvement in patient-reported symptoms of eye dryness, defined by a mean change in EDS from baseline to Day 84.
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Results from OPUS-3 showed that lifitegrast met the primary endpoint of significantly improving patient-reported symptoms of dry eye disease from baseline to Day 84 (treatment difference of 7.16; 95% CI: 3.04− 11.28; P=0.0007). In addition, lifitegrast met the secondary endpoints of symptom improvement at Days 14 and 42 [treatment difference of 7.85; 95% CI: 4.33−11.37 and 9.32; 95% CI: 5.44−13.20, respectively, (P<0.0001)].
Shire intends to use these data as part of the New Drug Application (NDA) resubmission for lifitegrast for the treatment of signs and symptoms for dry eye disease in the first quarter of 2016.
For more information call (800) 536−7878 or visit Shire.com.
