US009132087B2 (12) United States Patent (10) Patent No.: US 9,132,087 B2 Lichter et al. (45) Date of Patent: Sep. 15, 2015 (54) AURIS FORMULATIONS FOR TREATING (52) U.S. Cl. OTC DISEASES AND CONDITIONS CPC ................. A61 K9/0046 (2013.01); A61 K9/06 (2013.01); A61K 9/14 (2013.01) (75) Inventors: Jay Lichter, Rancho Santa Fe, CA (US); (58) Field of Classification Search Andrew M. Trammel, Olathe, KS (US); Fabrice Piu, San Diego, CA (US); Luis CPC .......... A61 K9/0046; A61 K9/06; A61 K9/14 A. Dellamary, San Marcos, CA (US); See application file for complete search history. Qiang Ye, San Diego, CA (US); Carl (56) References Cited Lebel, Malibu, CA (US); Michael Christopher Scaife, Los Altos, CA U.S. PATENT DOCUMENTS (US); Jeffrey P. Harris, La Jolla, CA 4,478,822 A 10, 1984 Haslam et al. (US) 4,530,840 A 7, 1985 Tice et al. 4,900,552 A 2f1990 Sanvordeker et al. (73) Assignees: OTONOMY, INC., San Diego, CA 4,938,763. 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Possibilities of use of thermosensitive polymers as active provisional application No. 61/074,583, filed on Jun. Substance carriers.” Polimery W Medycynie 38(1): 15-26, 2008 20, 2008, provisional application No. 61/060,425, (English language abstract). filed on Jun. 10, 2008, provisional application No. PCT/US2009/041320 International Search Report mailed Nov. 26, 61/048.878, filed on Apr. 29, 2008, provisional 2009. application No. 61/046,543, filed on Apr. 21, 2008, (Continued) provisional application No. 61/076,567, filed on Jun. 27, 2008, provisional application No. 61/076,576, Primary Examiner — Sarah Pihonak filed on Jun. 27, 2008, provisional application No. (74) Attorney, Agent, or Firm — Wilson Sonsini Goodrich & 61/160,233, filed on Mar. 13, 2009, provisional Rosati application No. 61/086,094, filed on Aug. 4, 2008, provisional application No. 61/083,830, filed on Jul. (57) ABSTRACT 25, 2008, provisional application No. 61/083,871, Disclosed herein are compositions and methods for the treat filed on Jul. 25, 2008, provisional application No. ment of otic disorders with immunomodulating agents and 61/087,951, filed on Aug. 11, 2008, provisional auris pressure modulators. In these methods, the auris com application No. 61/088,275, filed on Aug. 12, 2008, positions and formulations are administered locally to an provisional application No. 61/082,450, filed on Jul. individual afflicted with anotic disorder, through direct appli 21, 2008. cation of the immunomodulating and/or auris pressure modu lating compositions and formulations onto the auris media (51) Int. C. and/or auris internatarget areas, or via perfusion into the auris A6 IK9/00 (2006.01) media and/or auris interna structures. 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