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(12) Patent Application Publication (10) Pub. No.: US 2010/0021416 A1 LCHTER Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2010/0021416 A1 LCHTER Et Al US 2010 0021416A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2010/0021416 A1 LCHTER et al. (43) Pub. Date: Jan. 28, 2010 (54) CONTROLLED-RELEASE OTIC STRUCTURE (22) Filed: Jul. 20, 2009 MODULATING AND INNATE IMMUNE SYSTEMI MODULATING COMPOSITIONS Related U.S. Application Data AND METHODS FOR THE TREATMENT OF (60) Provisional application No. 61/082,450, filed on Jul. OTC DISORDERS 21, 2008, provisional application No. 61/091,205, filed on Aug. 22, 2008, provisional application No. (75) Inventors: Jay LICHTER, Rancho Santa Fe, 61/094,384, filed on Sep. 4, 2008, provisional applica CA (US); Benedikt VOLLRATH, tion No. 61/101,112, filed on Sep. 29, 2008, provi San Diego, CA (US); Sergio G. sional application No. 61/108,845, filed on Oct. 27. DURON, San Diego, CA (US); 2008, provisional application No. 61/140,033, filed on Carl LEBEL, Malibu, CA (US); Dec. 22, 2008, provisional application No. 61/156. Fabrice PIU, San Diego, CA (US); 771, filed on Mar. 2, 2009, provisional application No. Qiang YE, San Diego, CA (US); 61/091,200, filed on Aug. 22, 2008. Luis A. DELLAMARY, San Publication Classification Marcos, CA (US); Andrew M. TRAMMEL, Olathe, KS (US); (51) Int. C. Michael Christopher SCAIFE, A6II 47/48 (2006.01) Los Altos, CA (US); Jeffrey P. A6II 3/66 (2006.01) HARRIS, La Jolla, CA (US) A638/46 (2006.01) A6II 35/74 (2006.01) A 6LX 3/553 (2006.01) Correspondence Address: A6IP27/16 (2006.01) WILSON, SONSINI, GOODRICH & ROSATI 650 PAGE MILL ROAD (52) U.S. Cl. ..................... 424/78.17: 514/108; 424/94.6; PALO ALTO, CA 94304-1050 (US) 424/93.47: 514/221 (57) ABSTRACT (73) Assignees: OTONOMY, INC., San Diego, CA Disclosed herein are compositions and methods for the treat (US): THE REGENTS OF THE ment of otic disorders with otic structure modulating compo UNIVERSITY OF sitions administered locally to an individual afflicted with an CALIFORNLA, Oakland, CA (US) otic disorder, through direct application of these composi tions and compositions onto or via perfusion into the targeted (21) Appl. No.: 121506,091 auris structure(s). Patent Application Publication Jan. 28, 2010 Sheet 1 of 5 US 2010/0021416 A1 1000 -- Non-Sustained release 100--- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - Cmax ^ -H Sustained release s s as 10 w ss -H BimOdal release 1 s --- Cmin 0.1 H Time (days) FIG. 1 Patent Application Publication Jan. 28, 2010 Sheet 2 of 5 US 2010/0021416 A1 10000 7 L 1000 % / 100 W 1 O 1/ 2r 3 4 5 6 Percent CMC, by weight-> FIG. 2 Patent Application Publication Jan. 28, 2010 Sheet 3 of 5 US 2010/0021416 A1 100,00075,000 Hill|| || || || 1 || 100,00000:0// / / / 15,000 II////II, / / 7 / o|| IAAA Al-M 4 O 00 III///2 III/// MYf III//// / / / 441/ Y 25 HF/AAI//ZML-1 44 Hit4-H || - lAAA4 4 || J-1 sl//Z 1 1 -5 15 l/A4 44 -14 10 41||241|| 7 % METHOCEL Cellulose Ether FIG. 3 Patent Application Publication Jan. 28, 2010 Sheet 4 of 5 US 2010/0021416 A1 Semi Circular Canals eliptical window pinna Circular window 1-1 Vestibular nerve malleuS 1- auditory nerve COChlea tympanic cavity tympanic membrane auditory (eardrum) Stapes eustachian tube Canal FIG. 4 Patent Application Publication Jan. 28, 2010 Sheet 5 of 5 US 2010/0021416 A1 1000 Non-micronized otic agent 10 Solution Micronized otic agent Solution Non-micronized otic agent + gelling agent 1 - Cmin Micronized otic agent + gelling agent 0.1 Time (days) FIG 5 US 2010/0021416 A1 Jan. 28, 2010 CONTROLLED-RELEASE OTC STRUCTURE RefSum's syndrome, Usher's syndrome, or combinations MODULATING AND INNATE IMMUNE thereof. In some embodiments, the otic disorder is otitis SYSTEMI MODULATING COMPOSITIONS externa, otitis media, mastoiditis, AIED, Ramsay Hunts, rep AND METHODS FOR THE TREATMENT OF erfusion injury, labyrinthitis ossificans or combinations OTC DSORDERS thereof. 0005. The auris compositions and therapeutic methods CROSS-REFERENCE described herein have numerous advantages that overcome 0001. This application claims the benefit of U.S. Provi the previously-unrecognized limitations of compositions and sional Application No. 61/082,450, filed 21 Jul. 2008; U.S. therapeutic methods described in prior art. Provisional Application No. 61/091205, filed 22 Aug. 2008: U.S. Provisional Application No. 61/094,384, filed 4 Sep. Sterility 2008; U.S. Provisional Application No. 61/101,112, filed 29 Sep. 2008; U.S. Provisional Application No. 61/108,845, 0006. The environment of the inner ear is an isolated envi filed 27 Oct. 2008; U.S. Provisional Application No. 61/140, ronment. The endolymph and the perilymph are static fluids 033, filed 22 Dec. 2008; U.S. Provisional Application No. and are not in contiguous contact with the circulatory system. 61/156,771, filed 2 Mar. 2009; and U.S. Provisional Applica The blood-labyrinth-barrier (BLEB), which includes a blood tion No. 61/091,200, filed 22 Aug. 2008; all of which are endolymph barrier and a blood-perilymph barrier, consists of incorporated by reference herein in their entirety. tight junctions between specialized epithelial cells in the labyrinth spaces (i.e., the vestibular and cochlear spaces). The BACKGROUND OF THE INVENTION presence of the BLB limits delivery of active agents (e.g., otic 0002 Vertebrates have a pair of ears, placed symmetri structure modulating agent or innate immune system modu cally on opposite sides of the head. The ear serves as both the lating agents) to the isolated microenvironment of the inner sense organ that detects Sound and the organ that maintains ear. Auris hair cells are bathed in endolymphatic or perilym balance and body position. The ear is generally divided into phatic fluids and cochlear recycling of potassium ions is three portions: the outer ear, auris media (or middle ear) and important for hair cell function. When the inner ear is the auris interna (or inner ear). infected, there is an influx of leukocytes and/or immunoglo bulins (e.g. in response to a microbial infection) into the SUMMARY OF THE INVENTION endolymph and/or the perilymph and the ionic composition 0003. Described herein, in certain embodiments, are com of inner ear fluids is upset by the influx of leukocytes and/or positions, compositions, manufacturing methods, therapeutic immunoglobulins. In certain instances, a change in the ionic methods, uses, kits, and delivery devices for the controlled composition of inner ear fluids results in hearing loss, loss of release of an otic structure modulating agent or innate balance and/or ossification of auditory structures. In certain immune system modulating agent to at least one structure or instances, trace amounts of pyrogens and/or microbes trigger region of the ear. Disclosed herein, in certain embodiments, infections and related physiological changes in the isolated are controlled-release compositions for delivering an otic microenvironment of the inner ear. structure modulating agent or innate immune system modu 0007 Due to the susceptibility of the inner ear to infec lating agent to the ear. In some embodiments, the target por tions, auris compositions require a level of sterility that has tion of the ear is the middle ear (or auris media). In some not been recognized hitherto in prior art. Provided herein are embodiments, the target portion of the ear is the inner ear (or auris compositions that are sterilized with Stringent sterility auris interna). In other embodiments, the target portion of the requirements and are suitable for administration to the middle ear is both the auris media and the auris interna. In some and/or inner ear. In some embodiments, the auris compatible embodiments, the controlled-release compositions further compositions described herein are substantially free of pyro comprise a rapid or immediate release component for deliv gens and/or microbes. ering an otic structure modulating agent or innate immune Compatibility with Inner Ear Environment system modulating agent to the targeted auris structure. All 0008. Described herein are otic compositions with an compositions comprise excipients that are auris-acceptable. ionic balance that is compatible with the perilymph and/or the 0004. Also disclosed herein, in certain embodiments, are endolymph and does not cause any change in cochlear poten compositions and devices for the treatment of otic disorders, tial. In specific embodiments, osmolarity/oSmolality of the said compositions and devices comprising an otic structure present compositions is adjusted, for example, by the use of modulating agent or innate immune system modulating appropriate salt concentrations (e.g., concentration of sodium agent. Further disclosed herein, in certain embodiments, are salts) or the use of tonicity agents that render the composi methods for the treatment of otic disorders by administration tions endolymph-compatible and/or perilymph-compatible of a controlled-release composition comprising an otic struc (i.e. isotonic with the endolymph and/or perilymph). In some ture modulating agent or innate immune system modulating instances, the endolymph-compatible and/or perilymph agent to an individual in need thereof. In some embodiments, compatible compositions described herein cause minimal the otic disorder is otitis externa, otitis media, mastoiditis, disturbance to the environment of the inner ear and cause sensorineural hearing loss, ototoxicity, endolymphatic minimum discomfort (e.g., vertigo) to a Subject (e.g., a hydrops, labyrinthitis, Meniere's disease, Meniere's syn human) upon administration. Further, the compositions com drome, microvascular compression syndrome, Vestibular prise polymers that are biodegradable and/or dispersible, and/ neuronitis, acoustic trauma, presbycusis, cholesteatoma, oto or otherwise non-toxic to the inner ear environment. In some sclerosis, Scheibe syndrome, Mondini-Michelle syndrome, embodiments, the compositions described herein are free of Waardenburg's syndrome, Michel syndrome, Alexander's ear preservatives and cause minimal disturbance (e.g., change in deformity, hypertelorism, Jervell-Lange Nielson syndrome, pH or osmolarity, irritation) in auditory structures.
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