Auris formulations for treating otic diseases and conditions

Abstract

Disclosed herein are compositions and methods for the treatment of otic disorders with immunomodulating agents and auris pressure modulators. In these methods, the auris compositions and formulations are administered locally to an individual afflicted with an otic disorder, through direct application of the immunomodulating and/or auris pressure modulating compositions and formulations onto the auris media and/or auris interna target areas, or via perfusion into the auris media and/or auris interna structures.

1 .- 20 . (canceled) 
     
     
         21 . A method of treating an otic disease or condition comprising administering to an individual in need thereof a therapeutically effective amount of a composition, wherein the composition comprises an auris sensory cell modulating agent that reduces or inhibits auris sensory cell death, and about 14% to about 35% by weight of a polyoxyethylene-polyoxypropylene triblock copolymer. 
     
     
         22 . The method of  claim 21 , wherein the otic disease or condition is hearing loss. 
     
     
         23 . The method of  claim 21 , wherein the otic disease or condition is tinnitus. 
     
     
         24 . The method of  claim 21 , wherein the auris sensory cell modulating agent that reduces or inhibits auris sensory cell death is multiparticulate. 
     
     
         25 . The method of  claim 21 , wherein the pharmaceutical formulation is an auris-acceptable hydrogel. 
     
     
         26 . The method of  claim 21 , wherein the pharmaceutical formulation is an auris-acceptable thermoreversible gel. 
     
     
         27 . The method of  claim 26 , wherein the polyoxyethylene-polyoxypropylene triblock copolymer is Poloxamer 407. 
     
     
         28 . The method of  claim 21 , wherein the composition comprises about 15% to about 25% by weight of polyoxyethylene-polyoxypropylene triblock copolymer. 
     
     
         29 . The method of  claim 21 , wherein the composition comprises about 15% to about 18% by weight of polyoxyethylene-polyoxypropylene triblock copolymer. 
     
     
         30 . The method of  claim 26 , further comprising a viscosity enhancer. 
     
     
         31 . The method of  claim 30 , wherein the viscosity enhance is alginate. 
     
     
         32 . The method of  claim 21 , wherein the composition comprises: between about 0.1 mg/ml to about 70 mg/ml of the auris sensory cell modulating agent. 
     
     
         33 . The method of  claim 21 , wherein the composition comprises: between about 1 mg/ml to about 20 mg/ml of the auris sensory cell modulating agent. 
     
     
         34 . The method of  claim 21 , wherein the composition comprises: between about 1 mg/ml to about 10 mg/ml of the auris sensory cell modulating agent. 
     
     
         35 . The method of  claim 21 , wherein the composition comprises: between about 5 mg/ml to about 10 mg/ml of the auris sensory cell modulating agent. 
     
     
         36 . The method of  claim 21 , wherein the composition is formulated for administration into or near an auris interna and/or auris media target site. 
     
     
         37 . The method of  claim 36 , wherein the target site is the tympanic cavity, round window membrane or the crista fenestrae cochleae. 
     
     
         38 . The method of  claim 21 , wherein the composition is formulated for intratympanic administration. 
     
     
         39 . The method of  claim 21 , wherein the composition provides sustained release of a therapeutically effective amount of the auris sensory cell modulating agent into the ear. 
     
     
         40 . The method of  claim 21 , wherein the therapeutically effective amount of the auris sensory cell modulating agent induced expression of brain-derived neurotrophic factor (BDNF) in the ear.