Updated July 2015
Otonomy is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear. Founded in 2008 by Jay Lichter, PhD, of Avalon Ventures together with Jeffrey Harris, MD, PhD, and Allen Ryan, PhD, of UC San Diego, and Rick Friedman, MD, PhD, of the Keck School of Medicine at USC, Otonomy has developed a proprietary technology that is designed to deliver drug that is retained in the ear for an extended period of time following a single local administration. Utilizing this technology, Otonomy has advanced three product candidates into development: AuriPro™, OTO-104, and OTO-311.
AuriPro (formerly OTO-201) is a sustained-exposure formulation of the antibiotic ciprofloxacin in development for the treatment of middle ear effusion in pediatric patients undergoing tympanostomy tube placement (TTP) surgery. AuriPro has been formulated to provide a full course of treatment from a single dose administered by the ear, nose, and throat (ENT) physician during the TTP procedure.
There are approximately one million TTP surgeries each year in the United States, with three-fourths performed in children age five and under. Antibiotic ear drops are used in nearly all cases during and immediately following surgery even though they have not received FDA approval for this indication. Administration of ear drops in young children can be very challenging for caregivers and this is compounded by the fact that current antibiotic ear drop products require multi-dose, multi-day regimens for efficacy. Incomplete compliance with dosing regimens can compromise efficacy and increase the potential for bacterial resistance.
A New Drug Application (NDA) is under review by the FDA for the approval of AuriPro as a treatment of middle ear effusion in pediatric patients undergoing TTP surgery, with a Prescription Drug User Fee Act (PDUFA) action date of December 25, 2015. If approved within the standard review period, Otonomy anticipates a commercial launch for AuriPro in the United States in the first quarter of 2016.
OTO-104, which has been granted Fast Track designation by the FDA, is a sustained-exposure formulation of the steroid dexamethasone in development for the treatment of Ménière’s disease and other inner ear conditions. A Phase 2b single-dose efficacy trial has been completed with a total of 154 Ménière’s disease patients. The primary endpoint of the trial was reduction in vertigo frequency during Month 3 following treatment, compared to a one-month baseline period. In the topline analysis, OTO-104 demonstrated a 61% reduction from baseline in vertigo frequency in Month 3 vs. 43% for placebo which narrowly missed achieving statistical significance with a p value of 0.067. A similar positive trend was also observed during Month 2 following treatment. The trial achieved statistical significance (p < 0.05) for multiple prospectively defined secondary endpoints at multiple time points. Based on these results Otonomy intends to initiate two parallel Phase 3 trials.
Ménière’s disease is a chronic condition impacting more than 600,000 people in the United States that is characterized by acute vertigo attacks (extreme dizziness), tinnitus (ringing of the ear), fluctuating hearing loss, and a feeling of aural fullness. The underlying cause of Ménière’s disease is not well understood and there is no known cure or FDA-approved drug treatment.
OTO-311 is a sustained-exposure formulation of the NMDA receptor antagonist gacyclidine in development as a treatment for tinnitus. Otonomy expects to file an Investigational New Drug (IND) application and initiate a Phase 1 clinical trial for OTO-311 in 2015.
Otology Market Leadership
The emerging otology field provides a unique opportunity for Otonomy to establish a leading position in both the development and commercialization of innovative drug treatments. The company’s collaboration with researchers at UCSD has led to the establishment of Otonomy’s broad patent position covering sustained exposure of numerous therapeutic classes across a wide range of otic disorders. The combination of a large, underserved patient population, a small specialist ENT physician audience, and an absence of FDA-approved products creates the necessary conditions to allow Otonomy to independently advance its products through commercialization in the U.S.
- Otonomy Initiates Phase 2 Clinical Trial for AuriPro(TM) in Second Label Expansion Indication (7/28/15)
6275 Nancy Ridge Drive
San Diego, CA 92121
Tel: (858) 245-5200
Fax: (858) 200-0933
David Weber, PhD – President and CEO
Paul Cayer – Chief Financial & Business Officer
Carl LeBel – Chief Scientific Officer
Bob Savel – Chief Technical Officer
Anthony Yost – Chief Commercial Officer
Dean Hakanson, MD – Chief Medical Officer
Eric Loumeau – General Counsel and Chief Compliance Officer
$144M Series A-D (2008 – 2014)
$115M IPO (8/14)
$86M Follow-on (1/15)
Jeffrey Harris, MD, PhD
Professor and Chief, Division of
Otolaryngology/Head & Neck Surgery
School of Medicine
Allen F. Ryan, PhD
Professor of Surgery
Director Otolaryngology Research