Otonomy falls after Phase III Meniere’s disease failure

Otonomy Inc. (NASDAQ:OTIC) plummeted $17.22 (83%) to $3.58 after it said Otividex dexamethasone (OTO-104) missed the primary endpoint in the U.S. Phase III AVERTS-1 study to treat unilateral Meniere’s disease. The company, which lost $521.8 million in market cap, said it will halt the product's development, including the ongoing, identical EU Phase III AVERTS-2 trial.

On the primary endpoint, Otividex failed to significantly reduce the number of definitive vertigo days by Poisson Regression analysis from baseline to month three compared to placebo (58% vs. 55%, p=0.62). The candidate 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...