BioCentury
ARTICLE | Clinical News

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

November 30, 2017 11:47 PM UTC

Otonomy Inc. (NASDAQ:OTIC) reported top-line data from the double-blind, European Phase III AVERTS-2 trial in 174 patients with unilateral Meniere’s disease showing that a single 12 mg intratympanic injection of Otividex dexamethasone (OTO-104) met the primary endpoint of reducing the mean number of definitive vertigo days by Poisson Regression analysis from baseline to 3 months vs. placebo (reduction of 6.2 days vs. reduction of 3.7 days, p=0.029). In patients who completed daily diaries through 3 months (n=105), Otividex reduced vertigo frequency from baseline to 3 months by 68% vs. 40% for placebo. Otividex was generally well tolerated with no treatment-related serious adverse events reported. Otonomy plans to meet with FDA in 1Q18 to discuss next steps.

In August, Otonomy reported data from the identical U.S. Phase III AVERTS-1 trial in 165 patients with unilateral Meniere’s disease showing that Otividex missed the primary endpoint of reducing the number of definitive vertigo days from baseline to 3 months vs. placebo (p=0.62). At the time, the company said it would halt the product's development, including the AVERTS-2 trial (see BioCentury, Sept. 1)...

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