Remura bromfenac: Phase III data
Top-line data from the double-blind, placebo-controlled, U.S. Phase III WEST trial in 420 patients with dry eye disease showed that both doses of Remura missed the co-primary endpoints of significantly improving one sign and one symptom of dry eye disease at day 42 vs. placebo. Both doses of Remura significantly improved one sign and one symptom from baseline to 42 days (p<0.0001 for both), which was not a secondary endpoint. Remura was well tolerated.
In a post hoc analysis of females 51-70 years old, the high dose improved one sign of the disease vs. placebo. The company said on a July 28 conference call that this subgroup is the primary target audience for dry eye disease, and 55-60% of the intent-to-treat population in WEST were females over 50 years old. ...