Otonomy, Inc. announced the completion of patient enrollment in the Phase 2 clinical trial of OTO-313 in tinnitus. The randomized, double-blind, placebo-controlled trial enrolled 153 patients with persistent, unilateral tinnitus of at least moderate severity (target enrollment was 140 patients). Patients were randomized 1:1 to a single intratympanic injection of OTO-313 (0.32 mg) or placebo and are being followed for 4 months.

The primary endpoint is the same as reported for the successful Phase 1/2 trial: a responder analysis based on the proportion of patients who report a clinically meaningful improvement in the Tinnitus Functional Index (TFI) from baseline to Months 1 and 2 following treatment. Top-line results for all timepoints are expected to be available in mid-2022.