OTO-104 is in Phase Ib for Meniere disease, and OTO-203 is in preclinical studies for otitis media.

Otonomy closed a $38.5 million Series B financing co-led by Novo Ventures and RiverVest Venture Partners and joined by Domain Associates and TPG Biotech. Proceeds from the financing will support Otonomy’s first two programs through pivotal clinical studies as well as expansion of its pipeline of locally delivered drugs to treat disorders of the ear.

“Novo Ventures has been impressed by the ability of Otonomy’s novel delivery technology to generate excellent drug exposure in the target organ, and we expect that this will translate into important new treatment options for patients,” says Peter Bisgaard, partner of Novo Ventures, who now joins Otonomy’s board of directors. “Furthermore, we believe that the development of optimized drug treatments for disorders of the ear represents a very attractive investment opportunity based on the large population of patients affected and the lack of any FDA-approved drugs for hearing or balance disorders.”

OTO-104, Otonomy’s lead candidate, is a sustained-release version of the steroid dexamethasone currently in a Phase Ib trial for Meniere disease. Future studies are reportedly being planned for acute onset hearing loss. Otonomy is also developing OTO-203, an antibiotic/steroid combination product, for the treatment of otitis media. It is expected to enter clinical trials in 2011. Other product candidates will target acute and chronic forms of hearing loss, balance disorders, and tinnitus.

“Otonomy is a company that we have been following almost since its inception, and we have been pleased to see the rapid progress made by the team in advancing OTO-104 into clinical development and OTO-203 into IND-enabling studies,” remarks John McKearn, Ph.D., venture partner of RiverVest Venture Partners, who will also join Otonomy’s board. “We are confident that the intellectual property created by Otonomy in the field of sustained-release drug delivery to the ear will become very important and valuable as this new field matures.”

Otonomy was founded in 2008 by Avalon Ventures together with Jeffrey Harris, M.D., Ph.D., Rick Friedman, M.D., Ph.D., and Allen Ryan, Ph.D. Otonomy’s core technology is a sustained release formulation developed for optimal delivery of drugs from a single intratympanic injection. This financing is incremental to the $10 million Series A round, which closed with Avalon Ventures in June. Avalon also participated in the Series B round.

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