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|Title:||Controlled release immunomodulator compositions and methods for the treatment of otic disorders|
|Abstract:||Disclosed herein are compositions and methods for the treatment of otic disorders with immunomodulating agent compositions and formulations administered locally to an individual afflicted with an otic disorder, through direct application of these compositions and formulations onto or via perfusion into the targeted auris structure(s).|
|Inventor(s):||Lichter; Jay (Rancho Santa Fe, CA), Trammel; Andrew M. (Olathe, KS), Piu; Fabrice (San Diego, CA), Ye; Qiang (San Diego, CA), Dellamary; Luis A. (San Marcos, CA), Lebel; Carl (Malibu, CA), Harris; Jeffrey P. (La Jolla, CA)|
|Assignee:||Otonomy, Inc. (San Diego, CA) The Regents of the University of California (Oakland, CA)|
|Filing Date:||May 26, 2009|
|Claims:||1. A method of treating an otic disease or condition selected from autoimmune ear disease, and Otitis media, comprising administering an intratympanic composition on or near the round window membrane of the ear of an individual in need thereof, the composition comprising: between about 0.01% to about 20% by weight of a multiparticulate anti TNF alpha agent or pharmaceutically acceptable salt thereof; and a copolymer of polyoxyethylene-polyoxypropylene in an amount sufficient to provide a gelation temperature of between about 19.degree. C. and about 42.degree. C., and a gelation viscosity between about 15,000 cP and about 1,000,000 cP; such that sustained release of the anti TNF alpha agent across the round window membrane into the cochlea occurs for a period of at least 5 days after a single administration. |
2. The method of claim 1, wherein the multiparticulate anti TNF alpha agent is essentially in the form of micronized particles.
3. The method of claim 1, wherein the copolymer of polyoxyethylene-polyoxypropylene is Poloxamer 407.