Otonomy

Otonomy was founded in 2008 by Avalon Ventures and experts in the otology field in order to build the premier company dedicated to the treatment of otic disorders via localized drug delivery. This approach has already been widely adopted for the delivery of short-acting antibiotics to treat otitis media through a tympanostomy tube. In addition, otolaryngologists have demonstrated that the injection of steroids into the middle ear cavity can provide a therapeutic effect for patients with acute inner ear disorders such as Ménière’s disease and sudden sensorineural hearing loss. Expansion of this effort holds great promise for the treatment of chronic hearing loss, severe vertigo, and even tinnitus.

The key to Otonomy's leading position in this nascent field is the development of a proprietary formulation platform that provides sustained drug exposure from a single administration. Broad application of this technology has already been established across a number of therapeutic classes and from these, three product candidates have been advanced into development. OTO-104 is a steroid which is relevant for a wide range of hearing loss and balance disorders. A phase 1b clinical trial of OTO-104 has been completed in patients with Ménière’s disease and future studies are also anticipated for acute hearing loss. OTO-201 is an antibiotic intended to treat various middle ear conditions including recurrent or persistent otitis media. A phase 1b clinical trial of OTO-201 has been completed in pediatric patients with middle ear effusion at the time of tympanostomy tube replacement surgery. OTO-311 is a sustained-exposure formulation of the N-Methyl-D-Aspartate (NMDA) receptor antagonist gacyclidine. Emerging clinical data, including pilot studies conducted with gacyclidine, support the use of NMDA antagonists as treatments for tinnitus. All three product candidates are covered by an extensive patent estate filed by Otonomy to broadly protect the delivery of sustained-exposure drug treatments for otic disorders.

Since its inception, Otonomy has raised approximately $95 million from leading healthcare investors including OrbiMed Advisors, Novo Ventures, TPG Biotech, Domain Associates, Avalon Ventures, RiverVest Venture Partners, Aperture Venture Partners and Osage University Partners.