Otonomy's OTIVIDEX Fails To Separate From Placebo In Inner Ear Disorder Study

Otonomy Inc (NASDAQ: OTIC) has reported topline data from Phase 3 trial evaluating OTIVIDEX in patients with Ménière’s disease. It is an inner ear disorder that causes episodes of vertigo (spinning) and hearing loss.
The study did not achieve the primary endpoint, which was the count of definitive vertigo days in month three for OTIVIDEX vs. placebo for the intent-to-treat population (n=148). However, the analysis achieved statistical significance for the per-protocol population (n=136).
“Our focus turns to the strong pipeline we have built as recently highlighted by the successful clinical trial results for OTO-313 in tinnitus and OTO-413 in hearing loss. These programs provide an attractive opportunity for the company, with clinical readouts anticipated in mid-2022. We expect that our existing cash balance will permit us to achieve these clinical readouts as well as advance our preclinical hearing loss programs including OTO-825, gene therapy for congenital hearing loss,” said David Weber, president, and CEO.
The company previously reported a cash balance of $86.3 million as of December 31, 2020.
Price action: OTIC gained 4.64% at $5.64 in premarket on the last check Monday before the trading was halted.