Claims for Patent: 11,040,004

Summary for Patent: 11,040,004

Title:	Otic gel formulations for treating otitis externa
Abstract:	Disclosed herein are methods for the treatment of otic diseases or conditions with antimicrobial agent compositions and formulations administered locally to an individual afflicted with an otic disease or condition, through direct application of these compositions and formulations onto or via perfusion into the targeted auris structure(s).
Inventor(s):	Lebel; Carl (Malibu, CA)
Assignee:	OTONOMY, INC. (San Diego, CA)
Application Number:	15/705,101
Patent Claims:	1. A method of treating otitis externa or a sign or symptom thereof, comprising administering into an external ear canal of a subject in need thereof, an aqueous thermoreversible gel composition, wherein: the composition comprises about 6.0% by weight of micronized ciprofloxacin and 15-17% by weight of poloxamer 407, the dose volume of the composition administered to the subject comprises about 12 mg of micronized ciprofloxacin, and the dose volume of the thermoreversible gel composition administered to the subject is about 0.2 mL. 2. The method of claim 1, wherein the composition is free of butylated hydroxytoluene (BHT). 3. The method of claim 1, wherein the composition is preservative-free. 4. The method claim 1, wherein the composition further comprises tromethamine. 5. The method of claim 1, wherein the composition has a pH of about 7.0 to about 8.0. 6. The method of claim 1, wherein the otitis externa is associated with a bacterial infection. 7. The method of claim 6, wherein the bacterial infection is associated with Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus rettgeri, Proteus vulgaris, Proteus morgani, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Streptococcus faecalis, Alcaligenes faecalis, Klebsiella aerogenes, Klebsiella pneumonia, Haemophilus influenzae, Moraxella catarrhalis, or a combination thereof. 8. The method of claim 1, wherein otitis externa is acute otitis externa. 9. The method of claim 1, wherein the subject has experienced a symptom of acute otitis externa for less than six weeks, wherein the symptom is selected from decreased hearing, swelling of the ear canal, ear pain, fever, exudate from the ear canal, itching, redness, and combinations thereof. 10. The method of claim 1, wherein administering comprises contacting the ear canal with a tip of a syringe containing the aqueous thermoreversible gel composition. 11. The method of claim 10, wherein the tip of the syringe is advanced about 1 mm to about 8 mm beyond the cartilaginous/bony junction of the ear. 12. The method of claim 10, wherein the tip of the syringe is advanced about 5 mm beyond the cartilaginous/bony junction of the ear. 13. The method of claim 1, wherein the composition further comprises hydrochloric acid. 14. The method of claim 1, wherein the composition comprises about 0.4% to about 0.6% tromethamine by weight. 15. The method of claim 1, wherein the sign or symptom is edema, erythema, otorrhea, otalgia, temporary conductive hearing loss, shedding of the ear canal, redness of the ear canal, lack of cerumen, pain of the outer ear, external acoustic meatus inflammation with or without infection, itching, aural fullness, tenderness of the tragus and pinna, diffuse ear canal edema, conductive hearing loss or combinations thereof. 16. The method of claim 8, wherein the otitis externa is associated with intermediate and resistant bacterial strains to ciprofloxacin. 17. The method of claim 8, wherein there is onset of the sign or symptom of otitis externa within 48 hours.