Otonomy's Meniere’s disease candidate misses in Phase III

Otonomy Inc. (NASDAQ:OTIC) reported data from the double-blind, U.S. Phase III AVERTS-1 trial in 165 patients with unilateral Meniere’s disease who were experiencing 4 to 22 days with definitive vertigo episodes of >20 minutes showing that a single 12 mg intratympanic injection of Otividex dexamethasone (OTO-104) missed the primary endpoint of reducing the number of definitive vertigo days by Poisson Regression analysis from baseline to 3 months vs. placebo (58% vs. 55%, p=0.62). The company said it will halt the product's development, including the ongoing, identical EU Phase III AVERTS-2 trial.

Otividex also missed the secondary endpoints of improving the change in vertigo frequency from baseline (p=0.99), mean vertigo severity score (p=0.93) and average daily vertigo count (p=0.81) vs. placebo. Otonomy said it is reviewing its entire product pipeline and commercial efforts, and withdrawing its 2017 operating expense guidance...