SAN DIEGO, May 3 Otonomy, Inc. today announced the presentation of preclinical experimental results for OTO-104, the company's sustained release dexamethasone gel for the treatment of hearing and balance disorders. The studies demonstrate that OTO-104 can effectively deliver a prolonged and dose proportional exposure of dexamethasone to the inner ear when administered by direct injection into the ear. The data were presented on Saturday, May 1, at the 2010 Combined Otolaryngology Spring Meeting (COSM) in Las Vegas.
At the highest single dose of OTO-104, therapeutic levels of dexamethasone could be sustained for over four weeks in both animal species evaluated (guinea pigs and sheep). The studies also provide the first demonstration of dose proportionality whereby inner ear concentrations of dexamethasone are related to the dose of OTO-104 administered. OTO-104 was well tolerated in a broad set of safety evaluations.
"We are pleased to be the first to demonstrate sustained release drug delivery to the inner ear as this has been a goal of the otolaryngology research community for many years," said Jay Lichter, Ph.D., CEO and co-founder of Otonomy. "We are also excited to see how this optimized drug delivery profile will translate into patient benefit in our ongoing clinical trial with Meniere's disease patients."
OTO-104 is a patent-protected, sustained release dexamethasone gel designed for direct injection into the ear (an intratympanic or IT injection) as a potential treatment for hearing loss and balance disorders. Otonomy has initiated a prospective, randomized, placebo-controlled, multicenter, Phase 1b study of OTO-104 given as a single IT injection in subjects with unilateral Meniere's disease. While the primary endpoint of the study is safety and tolerability, a number of efficacy endpoints will be monitored, including the frequency of vertigo attacks experienced by patients pre- and post-treatment.
About Otonomy, Inc.
Otonomy is a clinical stage biopharmaceutical company developing novel drug therapies for disorders of the inner and middle ear. The company's core technology is a sustained release formulation developed for optimal delivery of drugs from a single intratympanic (IT) injection. Broad applicability of this delivery and formulation technology has already been established across a number of therapeutic classes, and two products have been advanced into active development. The first, OTO-104, is a sustained release formulation of the steroid dexamethasone. A clinical trial has been initiated in Meniere's disease patients, and future studies are being planned for acute hearing loss. Otonomy's second product, OTO-203, is a sustained release antibiotic being developed for the treatment of otitis media.
For more information visit: www.otonomy.com.
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SOURCE Otonomy, Inc.