OTO-104 is a sustained release dexamethasone gel designed for direct injection into the middle ear as a potential treatment for hearing loss and balance disorders. Otonomy's proprietary formulation is intended to overcome the limitations associated with short acting solutions which include the need for multiple IT injections and large variability of delivered dose. In addition to its work in the area of hearing loss, the company is also currently conducting a prospective, randomized, placebo-controlled, multicenter, Phase 1b study of OTO-104 given as a single IT injection for the treatment of unilateral Meniere's disease. While the primary endpoint of the study is safety and tolerability, a number of additional endpoints are being monitored, including the frequency of vertigo attacks experienced by patients pre- and post-treatment.
According to the National Institute on Deafness and Other Communication Disorders (NIDCD), approximately 17 percent (36 million) of American adults report some degree of hearing loss. Furthermore, the NIDCD estimates that approximately 15 percent (26 million) of Americans between the ages of 20 and 69 have high frequency hearing loss due to noise exposure at work or during leisure activities. In addition, there are more than 1 million cancer patients, including children, treated each year with chemotherapeutic agents known to cause irreversible hearing loss according to the United Kingdom's Royal National Institute for Deaf People (RNID).
About OtonomyOtonomy is a clinical stage biopharmaceutical company developing novel drug therapies for diseases and disorders of the inner and
|SOURCE Otonomy, Inc|
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