Key Takeaways:

1. The new method uses bone-conducted vibration and electrodes to detect vestibular system responses with lower sound intensity than traditional tests.
2. Supported by a $1.89 million NIH grant, the research targets balance dysfunctions affecting over 69 million Americans aged 40 and older.
3. The study aims to better understand age-related vestibular decline and its impact on balance and gait, with findings expected within the next two years.

Researchers in James Madison University’s College of Health and Behavioral Studies have developed a cutting-edge method to diagnose balance disorders such as Meniere’s disease and treat diseases common in middle-aged and elderly Americans. 

More than 69 million (35%) Americans 40 years and older experience balance system dysfunction, according to the Academy of Neurologic Physical Therapy. The JMU research on using vibration to diagnose balance disorders is being funded by a $1.89 million, five-year grant from the National Institutes of Health. 

Erin Piker, a professor of communication sciences and disorders, says the experimental measures she developed with her team will involve placing electrodes on the skin around the eyes and neck and then playing a stimulus through a bone vibrator placed behind the ear or on the forehead.  

“This type of stimulus causes the skull to vibrate and will give us a detectable reaction from the muscles we placed the electrodes over,” Piker says.  “The stimulus is more complex than what is typically used and allows us to make new kinds of measurements.” 

Piker says traditional tests use sound introduced to the ear with an earphone. With sound, the intensity level must be very high to elicit a detectable response. However, to obtain the kind of measurements she hopes for, the sound would have to be played too loud. 

With vibration, the sound does not need to be played as loud, Piker says. 

Piker says her research could help address balance system changes that occur with diseases such as Meniere’s disease. “We know the vestibular system is affected, but current findings are very mixed as to what parts and how much.” 

The study also will provide data on balance and gait to see how they correlate to everyday functions. 

“We are starting with looking at changes with aging,” Piker says. “We expect to see some decline in the vestibular system as we age, starting at middle age.” 

Piker says data collection could take a year or two before some early findings are published. Undergraduate and graduate students will have roles in the research along with a research audiologist who will be new to the department when hired.

Takeaways:

1. First-of-Its-Kind Success: SPI-1005 is the first treatment to demonstrate efficacy in addressing hearing loss and speech discrimination in Meniere’s disease, a condition with no FDA-approved therapies.
2. Clinical Trial Results: The SPI-1005 group showed significant gains in low-frequency hearing and speech discrimination compared to placebo, with improvements continuing during the open-label extension.
3. Future Outlook: Full trial data will be presented at the 2025 Association for Research in Otolaryngology Midwinter Meeting, offering insights into SPI-1005’s potential to transform Meniere’s disease management.

Sound Pharmaceuticals announced that the Phase 3 clinical trial involving SPI-1005, a novel anti-inflammatory compound (ebselen), for the treatment of Meniere’s Disease (STOPMD-3), achieved its co-primary endpoints for efficacy involving improvements in hearing loss and speech discrimination. 

Impact of Meniere’s Disease

Meniere’s disease (MD) is an inner ear disorder that involves fluctuating hearing loss and tinnitus, and episodic vertigo and/or dizziness. There are no FDA-approved medical treatments for MD, nor for the treatment of hearing loss, tinnitus, vertigo, or dizziness. SPI-1005 is an oral capsule containing 200 mg ebselen that has shown safety and efficacy in several Phase 2 clinical trials involving multiple hearing loss and tinnitus indications including MD.

For the definite diagnosis of MD, the American Academy of Otolaryngology-Head & Neck Surgery guidance requires audiometric documentation of low frequency hearing loss (i.e., ≥30 dB) in at least one ear using pure tone audiometry. Loss of speech discrimination, especially in noisy environments or when tinnitus is present, is common in MD and other forms of sensorineural hearing loss. MD is currently managed with low salt diets, thiazide diuretics, and oral or locally injected steroids. Unfortunately, this standard of care has not proven effective and is not FDA-approved for the treatment of MD.

About the Clinical Trial

STOPMD-3 enrolled adult subjects (N=221) with a history of definite MD and active symptoms into a randomized double-blind placebo-controlled trial (RCT) in which subjects received 28 days of either SPI-1005 (400 mg twice daily) or placebo treatment with monthly follow-up assessments of auditory and vestibular function through 84 days. Compliant patients could immediately enter an open label extension (OLE) of SPI-1005 treatment for up to 12 months. 

During OLE, subjects continued to receive SPI-1005 and had their auditory and vestibular function reassessed every 3 months. In both the intent-to-treat and per-protocol RCT analysis, the SPI-1005 group showed higher rates of improvement in low frequency hearing loss (≥10 dB gain at one low frequency from baseline) using pure-tone audiometry (LFPTA) and speech discrimination (≥4-word increase from baseline) using the words-in-noise (WIN) test than the placebo group at day 28, 56, and 84 of follow-up. 

Further Reading

On day 84, the SPI-1005 group showed a significant rate of LFPTA improvement over placebo (57.9% vs 36.5%, an increase of 58.6% over placebo, p-value=0.0037). When LFPTA criteria were increased to require a ≥10 dB gain at two adjacent low frequencies from baseline, the SPI-1005 group showed a significant rate of improvement of 204.4% over placebo (41.1% vs 13.5%, p-value <0.0001). On day 84, the SPI-1005 group showed a significant rate of WIN improvement of 54.4% over placebo (42.1% vs. 27.1%, p=0.0336).

During OLE, responder rates involving LFPTA and WIN continued to improve, and patient reported outcome measures for tinnitus, vertigo, aural fullness, and dizziness severity all improved significantly from baseline (≥30% on average, p-value <0.001).

“We would like to thank all of our investigators and study participants for contributing to this pivotal Phase 3 trial success involving SPI-1005,” says Jonathan Kil, MD, CEO of Sound Pharmaceuticals. A presentation of the full RCT/OLE data analysis as well as additional post-hoc analysis will occur at the Association for Research in Otolaryngology Midwinter Meeting in Orlando FL, Feb. 22-26, 2025.

Key Takeaways:

1. SPI-1005 is an oral capsule taken twice daily, showing significant improvement in hearing loss and tinnitus based on previous Phase 1b and 2b studies.
2. The Phase 3 trial, the longest for a hearing loss or tinnitus indication, enrolled 221 patients and included both a randomized controlled trial and an open label extension.
3. The study was led by distinguished professionals and involved leading academic centers, with interim topline results expected to be presented this quarter.

Sound Pharmaceuticals announced that the Phase 3 clinical trial involving SPI-1005, a novel anti-inflammatory, for the treatment of Meniere’s Disease (STOPMD-3) has been completed. SPI-1005 is an oral capsule taken twice daily and the only potential therapeutic to significantly improve hearing loss and tinnitus in Meniere’s Disease patients that was documented in two completed Phase 1b and 2b studies that enrolled over 165 patients. 

The STOPMD-3 study enrolled eligible patients into a randomized controlled trial (RCT) for three months followed by an open label extension (OLE) of SPI-1005 for six months (OLE 6-mo) and an optional six additional months (OLE 12-mo). STOPMD-3 is the longest treatment trial involving an investigational new drug ever completed for a hearing loss or tinnitus indication, according to the company. RCT data unblinding and presentation of the interim topline results will occur this quarter.

Further Reading: Sound Pharmaceuticals Completes Enrollment for Meniere’s Disease Drug Clinical Trial

STOPMD-3 randomization began on August 2, 2022 and the last patient last visit (OLE 12-mo) was completed on July 25, 2024. A total of 254 patients were screened for eligibility at 11 sites including some of the leading academic centers in the US. 221 eligible patients were randomized to either SPI-1005 treatment (400 mg twice daily for 28 days) or matching placebo treatment and followed for 84 days. 201 patients continued onto SPI-1005 OLE for up to 6 months and 12 months. 

“We are grateful to all the patients that participated in this pivotal trial of SPI-1005,” says Jonathan Kil, MD, co-founder and CEO. SPI-1005 is the only investigational new drug that was tested in a Phase 3 trial aimed at improving hearing loss, tinnitus, and/or dizziness over the last three years, according to the company.

Further Reading: Sound Pharma Gets Positive Data from Trial Treating Aminoglycoside-Induced Ototoxicity

STOPMD-3 was led by Dr Paul Lambert, Distinguished University Professor and Chair Emeritus of the Department of Otolaryngology-HNS at MUSC in Charleston, SC, and the past president of the American Neurotologic Society. “To our knowledge, this Phase 3 study is the longest continuous treatment trial to improve hearing loss/tinnitus in patients living with Meniere’s Disease,” Lambert says. Dr Lambert, Dr Shaun Nguyen, and their colleagues from MUSC also led the successful Phase 2b RCT involving SPI-1005 and MD patients.

About SPI-1005

SPI-1005 is an investigational new drug that contains ebselen, a new chemical entity. Ebselen is a selenorganic compound that mimics and induces glutathione peroxidase (GPx) activity and is effective in reducing neuroinflammation across the central and peripheral nervous system. GPx activity is critical to several cell types and tissues in the inner ear, retina, prefrontal cortex of brain, lung, and kidney, and is often reduced during exposures to environmental insults or aging. Loss of GPx activity has been shown to result in sensorineural hearing loss in multiple animal models. 

SPI-1005 is being developed for several neurotologic indications including noise-induced hearing loss and two types of ototoxicity (hearing loss, tinnitus, dizziness, or vertigo) caused by aminoglycoside antibiotics (such as tobramycin or amikacin) or platinum-based chemotherapy (such as cisplatin or carboplatin). To date, no significant drug-drug interactions have been observed across multiple study populations including bipolar mania and treatment-resistant depression.

About Sound Pharmaceuticals

A privately held biotechnology company, Sound Pharmaceuticals is testing SPI-1005 under five other active Investigational New Drug Applications involving several neurotologic indications including aminoglycoside-induced ototoxicity co-funded by the CF Foundation and cochlear implant patients co-funded by Med-El. Details of the SPI-1005 clinical trials can be viewed online at www.clinicaltrials.gov or by visiting www.soundpharma.com.

Featured image: Dreamstime

The partnership will conduct targeted outreach, collaborative patient education programs, and data-driven research, according to the companies.

“Joining forces with VeDA is a significant milestone for Spiral, as it aligns with our commitment to address the unmet medical needs in the field of inner ear disorders,” says Hugo Peris, CEO of Spiral Therapeutics. “We’re honored to support VeDA’s mission and excited about the opportunity to significantly improve patient lives.”

Further reading: Vestibular Assessment in Infant Cochlear Implant Candidates

This collaboration grants Spiral access to VeDA’s Patient Registry on Meniere’s patients, enriching its ongoing research efforts. Additionally, the Vestibular Disorders Association will facilitate targeted outreach to Meniere’s clinicians and patients in the United States and Australia. Both organizations will also collaborate on educational programs to further patient understanding of treatment nuances such as the placebo effect.

“VeDA is honored to partner with Spiral in our mutual effort to support Meniere’s patients on their journey back to balance,” says Cynthia Ryan, executive director of VeDA. “We’re excited about the potential their new treatment offers to improve the lives of people struggling with vertigo, hearing loss, and tinnitus.”

Altamira Therapeutics, a company that develops RNA-based therapeutics, reports highlights from a peer reviewed article showing the efficacy of oral betahistine in the treatment of posterior canal benign paroxysmal positional vertigo (BPPV) when administered along with a canal repositioning procedure, the Epley maneuver.

The article was published in the journal Medicine and describes the results from a meta-analysis of nine randomized controlled trials with 860 posterior canal BPPV patients, of which 432 were treated with Epley’s maneuver plus betahistine, and 428 solely underwent Epley’s maneuver. According to the meta-analysis, Epley’s maneuver plus the use of betahistine resulted in a significantly greater reduction in dizziness handicap as measured by the Dizziness Handicap Inventory (DHI) compared to Epley’s maneuver alone (p = 0.001).

Betahistine is a small molecule structural analog of histamine and acts as an agonist at the H1 histamine receptor and as an antagonist at the H3 histamine receptor, report experts. Unlike histamine, it crosses the blood-brain-barrier. Betahistine is known to increase the release of histamine, acetylcholine, dopamine and norepinephrine in the brain. It increases cochlear, vestibular and cerebral blood flow and facilitates vestibular compensation and inhibits neuronal firing in the vestibular nuclei. Betahistine for oral administration is reportedly approved in about 115 countries (with the U.S. being a notable exception) for the treatment of vertigo and Meniere’s disease. Despite its good safety profile, the clinical utility of orally administered Betahistine is limited due to poor bioavailability.

Experts say that BPPV is characterized by repeated episodes of vertigo (dizziness) produced by changes in the head position relative to gravity, e.g. when tipping the head backward. It is typically caused by dislodged inner ear particles (otoconia) in one of the semicircular canals, most often the posterior canal. Reportedly, the debris elicits unwanted vestibular stimulation and is often cleared through physical repositioning procedures such as the Epley maneuver, which is strongly recommended by the Clinical Practice Guideline of the American Academy of Otolaryngology – Head and Neck Surgery. According to the academy, since a patient may experience dizziness and instability for some time even after a successful maneuver, betahistine as an antivertigo drug is frequently administered to help accelerate their resolution.

According to a study published in the journal Otolaryngology – Head and Neck Surgery, BPPV is the most common type of vertigo, which accounts for 17 to 42% of all diagnosed cases. A primary complaint of dizziness accounts for 5.6 million clinic visits in the United States per year. Experts say that patients, suffering from BPPV, experience significant inconveniences and disabilities during symptomatic episodes, as they interfere with day-to-day activities such as driving a car or climbing stairs;BPPV generally emerges in the elderly with a peak onset in the between 50-60 years of age.

Altamira has been developing AM-125, a patented formulation of betahistine for intranasal administration, for the treatment of acute vestibular syndrome (AVS), which may be triggered by a variety of causes including trauma, infection or inner ear fluid disturbances such as in BPPV. The company states that by avoiding the fast metabolism after oral intake, intranasal delivery of AM-125 achieves higher bioavailability of betahistine (5-to-29 times higher). AM-125 has been reportedly tested in a Phase 2 clinical trial (“TRAVERS”) with patients suffering from AVS following vestibular surgery. Researchers noted that compared to placebo, AM-125 treatment helped accelerate vestibular compensation and alleviate signs and symptoms of vestibular dysfunction. The Company expects to file an IND application for intranasal betahistine (AM-125) with the FDA in May 2023, including the protocol for its Phase 2 clinical trial in BPPV.

“We are pleased to see betahistine’s clinical utility further confirmed in this meta-analysis of several studies in BPPV patients,” commented Thomas Meyer, PhD, Altamira’s founder, chairman and CEO. “Following the positive outcomes in surgery-induced AVS in the TRAVERS trial, we feel vindicated in our choice of BPPV to advance the clinical development program for AM-125. Where marketed, BPPV has traditionally been one of the most frequent indications for oral betahistine. We look forward to submitting the IND application shortly which will be an important milestone on our way to transfer the innovative AM-125 program to one or several partners as we are repositioning the Company around our RNA delivery technology.”

For more information about Altamira, visit the company website.

Source: Altamira

Images: Altamira; Photo 249210344 © Andrey Popov | Dreamstime.com

For example, otoacoustic emissions are sounds created by the ear in response to sound stimuli, and the auditory brainstem response is an electrical response to sound stimuli. They are widely used in newborn hearing screenings, clinics, and research labs, but very little is known regarding their biological origin in the inner ear. Knowing and understanding the origins of these physiologic measures would improve our knowledge of hearing processes in normal ears and improve diagnostic assessments.

Low-frequency hearing and hearing loss is another prominent focus of Lichtenhan’s research. This is important because speech sounds, music, and bothersome background noise have large components that are low frequency in nature. They developed a new objective measurement of low-frequency hearing called the Auditory Nerve Overlapped Waveform (ANOW). A summary of the research involving the ANOW was published on the Washington University School of Medicine in St Louis website. The ANOW is said to be useful because it overcomes a long-standing problem of how to objectively measure low-frequency hearing.

Lichtenhan and colleagues have now used the ANOW to detect early low-frequency hearing loss in an animal model of Meniere’s disease, a poorly understood condition characterized by hearing loss, tinnitus, and episodic vertigo. This early detection may allow treatment efforts to be initiated before unrecoverable damage is done to the inner ear.

“Creating a reliable animal model of Meniere’s disease was technically very challenging,” says Dr Lichtenhan. “The lab has benefitted from a host of very talented postdoctoral fellows in recent years.” Lichtenhan credits the work of lab members Uzma Wilson, AuD, Choongheon Lee, PhD, Carla Valenzuela, MD, and Shannon Lefler, AuD, for the current progress.

Collaborators have also helped Lichtenhan with many of his challenging projects. He credits Alec Salt, PhD, and his very generous lab staff as constant sources of inspiration and technical help. Shawn Goodman, PhD, at the University of Iowa, and John Guinan, PhD, at Harvard Medical School, are also productive and harmonious sources of technical and scholarly collaboration.

Further studies are necessary to develop techniques that will enable a differential diagnosis of Ménière’s disease and monitoring of disease progression and response to treatment. In addition to low-frequency hearing loss, they hope that other patient symptoms like hyperacusis (normal sounds seem too loud) and diplacusis (sounds perceived differently by each ear) will provide clues to a better understanding of this debilitating disease.

Source: Washington University School of Medicine in St Louis

Images: Washington University School of Medicine in St Louis

“Ménière’s disease has a lot of factors and can be mimicked by other illnesses. To add to that, it is an episodic disease that can take months, or even years, to diagnose,” said Gregory J. Basura, MD, PhD, Chair of the Guideline Development Group. “We hope that this guideline will help support more accurate diagnoses and thereby improve patients’ quality of life.”

Ménière’s disease is defined by spontaneous vertigo attacks, each lasting 20 minutes to 12 hours, with low- to mid-frequency sensorineural hearing loss in the affected ear before, during, or after one of the episodes of vertigo. The clinical practice guideline (CPG) defines vertigo as the feeling of spinning or moving when one is not moving. This is different from dizziness, which can mean feeling lightheaded or feeling like passing out.

Ménière’s disease is almost exclusively reported in adults, with less than 3% of cases estimated to occur in children younger than 18 years old. The disease is most prevalent between ages 40 to 60 years, with peak onset in the 40s and 50s. In many patients, the most detrimental decline in hearing and balance function occurs within the first decade of diagnosis, yet patients continue to have longstanding deficits that make Ménière’s disease a chronic disease. It is important to evaluate and document the hearing in both ears as a subset of patients will eventually experience Ménière’s disease bilaterally.

The guideline discusses the background on possible causes of Ménière’s disease, disorders that present similarly to it, and the ways in which the disease can progress. “The guideline aims to reduce the subjectivity of diagnosis and treatment for Ménière’s disease and to provide some objective standards based on the literature available today,” said Basura. “This new CPG gives providers some optimal tools with which to make their clinical decisions.”

The CPG is intended for all healthcare providers in any setting who are likely to encounter, diagnose, treat, and/or monitor patients with suspected Ménière’s disease. This includes emergency medicine, primary care, otolaryngology, neurology, audiology, and physical/vestibular therapy. The target patient for the guideline is anyone 18 years of age or older who has a suspected diagnosis of definite or probable Ménière’s disease.

Source: The American Academy of Otolaryngology‒Head and Neck Surgery Foundation

Lewis was diagnosed with Meniere’s disease in 2018 after a performance in which his hearing loss prevented him from singing on-key.

“And I went on stage and it was horrible,” Lewis was quoted in the article as saying. “It was just unbelievable. Couldn’t hear a thing. Sang out of tune. Had the worst night of my life.”

Huey Lewis and the News was forced to cancel their tour that year, after a 4-decade run. He is now unable to sing or perform, according to CBS.

Lewis said that, if not for the diagnosis, he would still be singing and performing.

“All those shows. All those shows were canceled,” Lewis was quoted as saying. “And I miss the guys. I miss the camaraderie, you know?”

To read the article in its entirety, please click here for the CBS News website. “CBS Sunday Morning” will be aired on January 26, beginning at 9 am EST and is rebroadcast on Pop TV at 12:30 pm EST. The show also streams on CBSN beginning at 9:30 am EST and repeated at 1 pm EST, and is available on cbs.com, CBS All Access, and On Demand.

Source: CBS News

In the past, treatment of extreme cases of Ménière’s disease included severing the vestibular nerve or surgical removal of the entire vestibular organ.  Now, a less invasive treatment can be utilized, with an antibiotic called gentamicin, Karl Landsteiner University of Health Sciences announced on its website. By placing the antibiotic—an known ototoxin—into the middle ear, a side effect of the drug can be used therapeutically, says the university: Gentamicin is said to reduce the excitability of the vestibular cells in a targeted manner. Researchers have now reexamined 32 Austrian treatment cases between 2012 and 2015 and evaluated the results.

“Our evaluations confirm the effectiveness of this simple treatment method,” explained Dr Béla Büki, head of the outpatient department for hearing and balance disorders at the Krems University Hospital of Krems. “In over a third of the cases, only a single injection was necessary to achieve a noticeable and lasting relief of the symptoms.”

The results from Austria thus confirmed other studies in which this treatment method was used therapeutically, according to the school’s announcement.  However, in some cases, the initial effect of the treatment subsided after a few months and further injections were necessary to achieve a more lasting effect.

Dr Heinz Jünger was particularly interested in whether details of the initial treatment success could be used to predict the long-term course of symptom relief. The effect of the treatment on the individual parts of the equilibrium organ—including the labyrinth, which consists of three bony archways arranged in a spatially complex distribution to each other—was analyzed.

“In fact, our evaluation showed that the effect of the antibiotic in one channel of the labyrinth correlated strongly with its effect in the other two,” Büki said.

The research team also evaluated data from a measurement method designed to detect human reflex, known as the vestibulo-ocular reflex (VOR). This reflex compensates for rapid head movements with opposite eye movements, stabilizing images on the retinas and allowing people to focus on images even when the head is moving. In disorders of the vestibular system, this reflex is reduced to varying degrees and can be used as a measure of the degree of the disease or the success of treatment. By evaluating these data, it was found that the initial success of the treatment did not indicate whether another injection of the antibiotic would be necessary in a few months, and researchers are utilizing a “wait-and-see” approach.

The detailed analysis of a very simple form of treatment for a rare and complex disease is a notable example of research at KL Krems, which focuses on niche fields in areas relevant to health policy.

Source: Karl Landsteiner University of Health Sciences 

Key Elements of Business Plan

• Complete Clinical Development of OTIVIDEX for Ménière’s Disease: As previously announced, the AVERTS-2 Phase 3 trial achieved its primary endpoint (p value = 0.029) with OTIVIDEX demonstrating clinically significant treatment benefit for patients with Ménière’s disease. Although this trial was terminated early, the patient data was collected according to the study protocol and analyzed according to the statistical analysis plan previously reviewed by the US Food and Drug Administration (FDA). The company believes that these actions preserved the integrity of the clinical trial and that AVERTS-2 meets the requirements to serve as one of two successful Phase 3 trials requested by the FDA at the End-of-Phase 2 meeting. The company plans to meet with the FDA during the first quarter of 2018 to review these results and discuss remaining clinical requirements for registration of OTIVIDEX in patients with Ménière’s disease.
• Advance Development of Multiple Programs for Hearing Loss and Tinnitus: Otonomy plans to continue the development of multiple programs for the prevention and treatment of sensorineural hearing loss, and the treatment of tinnitus. The hearing loss programs, currently in preclinical development, involve the anatomical and functional repair of ribbon synapses, protection of hair cells from chemotoxicity, and regeneration of hair cells. Otonomy is also developing gacyclidine, a selective NMDA receptor antagonist, for the treatment of tinnitus. Hearing loss and tinnitus affect large patient populations and are important unmet medical needs because they have a significant burden on patients and lack effective treatments.
• Discontinue Commercial Support and Divest OTIPRIO: Otonomy is eliminating employment positions and ceasing programs related to the commercialization and market support of OTIPRIO. This action does not impact the current approval status of OTIPRIO with the FDA or the ongoing review of the Supplemental New Drug Application (sNDA) for OTIPRIO in acute otitis externa. Discussions are underway to divest OTIPRIO, which will continue to be available for purchase by customers.
• Leverage Cost Savings and Strong Balance Sheet to Support Plan: Eliminating commercial personnel reduces Otonomy’s headcount to approximately 50, and will reduce future operating expenses significantly. Including severance payments and commercial program wind-down costs, total GAAP operating expenses for 2017 are expected to total in the range of $95-$100 million with Non-GAAP expenses totaling in the range of $73-$78 million. Otonomy expects its cash balance including cash, cash equivalents, and short-term investments to total $118-$123 million at the end of 2017. While Otonomy is not prepared to provide operating expense guidance for 2018 at this time, eliminating expenses related to OTIPRIO commercialization is expected to provide cash savings for the company estimated to total more than $20 million next year.

“The positive AVERTS-2 results support our continued development of OTIVIDEX in Ménière’s disease, and the clinically significant treatment benefit experienced by patients in this trial highlights the important unmet medical needs that our development pipeline can address in the untapped field of otology,” said David A. Weber, PhD, president and CEO of Otonomy. “Today’s announcements outline our plan to focus resources on advancing our pipeline and to eliminate the cash burn associated with OTIPRIO commercialization. With these changes, we believe that our existing cash balance provides sufficient runway to complete the clinical development required for US registration of OTIVIDEX in Ménière’s disease and advance our other programs. We look forward to outlining our program timelines in the first quarter of 2018,” added Weber.

Source: Otonomy