Otonomy Reports Positive Top-Line Results from Phase 1/2 Clinical Trial of OTO-313 in Patients with Tinnitus - Seite 2

 

A single intratympanic injection of OTO-313 was well-tolerated with lower incidence of adverse events than the placebo group.

“We are excited to announce these positive clinical results for OTO-313 and to advance this potential treatment for patients suffering from the high burden of persistent tinnitus,” said David A. Weber, Ph.D., president and CEO of Otonomy. “This is also a great start to our three planned clinical trial readouts with results for our OTO-413 Phase 1/2 trial expected in the fourth quarter of 2020 and results from the Phase 3 trial of OTIVIDEX in Ménière’s disease expected in the first quarter of 2021.”

"Tinnitus is a common problem that affects millions of people around the world. A significant proportion of patients experience moderate to severe tinnitus, which can negatively impact sleep and relaxation, disrupt the ability to focus at work and at home, create feelings of distress and anxiety, and lower overall quality of life,” said Kenneth Maxwell, M.D., a Neurotologist at Piedmont Ear Nose & Throat Associates in Winston-Salem, North Carolina and an investigator in the OTO-313 Phase 1/2 trial. “Unfortunately, there are no FDA approved drug treatments for tinnitus and existing approaches rely on coping strategies. Therefore, I am very encouraged by the treatment response observed with OTO-313 in this trial as well as the consistency of the improvement for OTO-313 responders across all four tinnitus endpoints examined in this trial, and I look forward to participating in future clinical studies.”

Webcast and Conference Call

Otonomy management will host a webcast and conference call regarding these program updates at 4:30 p.m. ET / 1:30 p.m. PT today. The live call may be accessed by dialing [phone] for domestic callers and [phone] for international callers with conference ID code number: 4273643. A live webcast of the call will be available online in the investor relations section of Otonomy’s website at www.otonomy.com and will be archived there for 30 days.

About Tinnitus

Tinnitus is the medical term for the perception of noise when there is no sound. It is often described as a ringing in the ear but can also sound like roaring, clicking, hissing or buzzing. Tinnitus is often caused by cochlear injury due to excessive noise, physical trauma, persistent ear infection or exposure to ototoxic agent, leading to over-activation of auditory nerve fibers and the perception of noise in the absence of an external stimulus. Approximately 10 percent of U.S. adults suffer from the condition, which can severely impact daily activities and result in anxiety and depression. Tinnitus also accounts for the most prevalent service-connected disability among veterans with an estimated cost exceeding $2 billion. There are currently no FDA approved drug treatments for tinnitus.