What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.
That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company and bring drug development to neurotology (the treatment of inner ear neurological disorders such as vertigo, hearing loss, and tinnitus). Otonomy was founded in 2008 and has pioneered the ability to achieve sustained drug exposure in the inner ear via a single local administration called an intratympanic injection. This simple procedure routinely performed by ENTs in the office holds the potential to revolutionize treatment for neurotology, much in the same way that intravitreal injections transformed treatment in ophthalmology.
Leveraging this technology, Otonomy has built a broad product pipeline addressing the largest market opportunities in neurotology. This year is expected to be transformative for the company with three clinical trial readouts, including a Phase 3 trial in Ménière’s disease. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Take for instance Ménière’s disease, an acute vertigo disorder accompanied by hearing loss and tinnitus that affects more than 850,000 people in the U.S. As experienced by Otonomy’s founder, the vertigo attacks associated with Ménière’s disease occur without warning, last from minutes to hours and can recur for months. When the world is spinning, patients can’t function either at home or at work, and there are no FDA-approved drug treatments to help reduce the frequency or severity of attacks. Otonomy has completed one successful Phase 3 trial for OTIVIDEXTM and results of an ongoing Phase 3 trial are expected in the third quarter of 2020.
Tinnitus (ringing in the ear) is another neurotological condition that can significantly affect a person’s physical and emotional well-being. Thirty million people in the U.S. experience tinnitus, and for 8 million the ringing is severe enough that it impacts their ability to sleep, relax, and concentrate at work. In these cases, anxiety and depression are common. Unfortunately for patients, there are no FDA-approved tinnitus drug treatments available. To address this need, Otonomy is developing OTO-313 with results from a Phase 2 trial expected in the second quarter of 2020.
Affecting nearly half a billion people worldwide, hearing loss is the most common disorder in neurotology and is only expected to grow as our population ages and our world becomes noisier. Often, the first sign is difficulty understanding a conversation in a noisy environment. Researchers call this “speech-in-noise” hearing difficulty and have demonstrated that it is due to damaged neuronal connections in the ear. Otonomy is evaluating OTO-413 for this condition with results from a Phase 1/2 trial expected in the second half of this year.
“Neurotological diseases affect millions of people of all ages, and they all deserve a future less encumbered by the daily burden of hearing and balance disorders,” says David A. Weber, Ph.D., President and CEO of Otonomy. “Our three clinical milestones in 2020 provide a transformational opportunity for Otonomy and will, we hope, serve as an important inflection point for the emergence of this exciting new field.”
To follow the latest developments on the neurotology field and Otonomy, visit www.otonomy.com.
Actual results may differ from those indicated from the forward-looking statements herein as result of risks and uncertainties as described in the risk factors in Otonomy’s filings with the SEC.