Shire Plc announces updates from Phase 3 clinical program for Lifitegrast in Adults With Dry Eye Disease


Wednesday, 30 Apr 2014 09:00am EDT 

Shire Plc:Presented study results from pivotal Phase 3 OPUS -2 study investigating lifitegrast (5 pct ophthalmic solution) in adults with dry eye disease.In addition comapny announces top-line results from prospective, randomized, double-masked, placebo-controlled, long-term (one-year) Phase 3 SONATA safety study.Symptom of improvement in dry eye compared with placebo (P<0.0001), but did not meet the second co-primary endpoint of the sign of inferior corneal staining (P=0.6186).Secondary endpoints were only descriptive in nature and were consistent with improvement in symptoms and lack of improvement in signs.There were no ocular serious treatment-emergent adverse events (TEAEs) or drug-related serious TEAEs reported.Says most commonly reported TEAEs associated with lifitegrast were dysgeusia (altered sense of taste) (16.2 pct vs. 0.3 pct for placebo), instillation site irritation (7.8 pct vs. 1.4 pct for placebo).Says instillation site reaction (7 pct vs. 1.1 pct for placebo), and visual acuity reduced (5.0 pct vs. 6.4 pct for placebo). 

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