OTIC - Otonomy issues update for Otividex and OTO-313

After review of Otonomy's ([[OTIC]] +0.7%) Otividex statistical analysis plan, the FDA confirms use of the Negative Binomial model for analysis of the primary endpoint in the ongoing Phase 3 trial in Ménière’s disease (inner ear disorder). As previously reported, enrollment is complete, and results are expected in 1Q 2021, with submission of a marketing application expected in Q3 of 2021.Additionally, the company finalized the design of Phase 2 trial for OTO-313 in tinnitus and expects to start study in Q1 of 2021. It will evaluate the same dose for OTO-313 in a Phase 2 trial that will enroll an enriched unilateral tinnitus patient population, by excluding patients with severe hearing loss and increase the minimum TFI score required for entry, as well as expand patient population eligible for enrollment by increasing the time from tinnitus onset.

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Otonomy issues update for Otividex and OTO-313