Anterior segment drug delivery

Abstract

A therapeutic system comprises an ocular insert placed on a region outside an optical zone of an eye. The ocular insert comprises two structures: a first skeletal structure and a second cushioning structure. The first structure functions as a skeletal frame which maintains positioning of the implant along the anterior portion of the eye and provides support to the second, cushioning structure. This first structure maintains the attachment of the therapeutic system to the anterior portion of the eye for at least thirty days. In some embodiments the first structure remains a constant size and shape, e.g. a ring shape, a ring with haptics, or a curvilinear ring that is confined to and restrainingly engages the inferior and superior conjunctival fornices so as to retain the implant within the tear fluid and/or against the tissues of the eye.

1 - 23 . (canceled) 
     
     
         24 . An ocular insert for use in an eye, the eye having upper and lower lids, the insert disposable along an anterior eye surface of the eye outside the optical zone, the insert comprising:
 an inner structure comprising a loop having a circumferential length, the inner structure configured to conform to a radius of curvature of the eye;   an outer structure supported by the inner structure, the outer structure comprising one or more tubular segments of a drug delivery matrix surrounding the circumferential length of the loop, the outer structure forming an anterior surface, a posterior surface, an inner edge, and an outer edge of the ocular insert along the circumferential length; and   at least one drug dispersed in the drug delivery matrix so as to release a safe and therapeutically effective quantity of the drug to the eye for each of a plurality of days.   
     
     
         25 . The ocular insert of  claim 24 , wherein the plurality of days comprises at least 30 days, at least 60 days, at least 90 days, or up to about 180 days. 
     
     
         26 .- 29 . (canceled) 
     
     
         30 . The ocular insert of  claim 24 , wherein the at least one drug comprises one or more member selected from the group consisting of:
 a steroid selected from the group consisting of at least one of glucocorticoids, aprogestins, amineralocorticoids, corticosteroids, cortisone, hydrocortisone, prednisone, prednisolone, methylprednisone, triamcinolone, fluoromethalone, dexamethasone, medrysone, betamethasone, loteprednol, fluocinolone, flumethasone, rimexolone mometasone, androgens, testosterone, methyltestosterone, and danazol;   a non-steroidal anti-inflammatory (NSAID) selected from the group consisting of at least one of piroxicam, aspirin, salsalate, diflunisal, ibuprofen, ketoprofen, nabumetone, piroxicam, naproxen, diclofenac, indomethacin, sulindac, tolmetin, etodolac, ketorolac, oxaprozin, and celecoxib;   an antibiotic selected from the group consisting of at least one of amoxicillin, penicillin, sulfa drugs, erythromycin, streptomycin, tetracycline, clarithromycin, terconazole, azithromycin, bacitracin, ciprofloxacin, evofloxacin, ofloxacin, levofloxacin, moxifloxacin, gatifloxacin, aminoglycosides, tobramycin, gentamicin, polymyxin B combinations, wherein the polymyxin B combinations are selected from the group consisting of polymyxin B/trimethoprim, polymyxin B/bacitracin, and polymyxin B/neomycin/gramicidin;   a glaucoma treatment medication selected from the group consisting of at least one of beta-blockers, mitotics, carbonic anhydrase inhibitors, prostaglandins, prostaglandin analogs, seretonergics, muscarinics, dopaminergic agonists, and adrenergic agonists,   wherein the beta-blockers are selected from the group consisting of timolol, betaxolol, levobetaxolol, and carteolol,   wherein the mitotics are selected from the group consisting of pilocarpine,   wherein the carbonic anhydrase inhibitors are selected from the group consisting of brinzolamide, and dorzolamide,   wherein the prostaglandin analogs are selected from the group consisting of travoprost, bimatoprost, and latanoprost, and   wherein the adrenergic agonists are selected from the group consisting of apraclonidine, and brimonidine;   an antihistamine and mast cell stabilizer selected from the group consisting of at least one of ketorolac tromethamine, ketotifen fumarate, loteprednol, epinastine HCl, emedastine difumarate, azelastine hydrochloride, olopatadine hydrochloride;   a chronic care anti-allergenic product selected from the group consisting of at least one of pemirolast potassium, nedocromil sodium, lodoxamide tromethamine, and cromolyn sodium; and   a dry eye medication selected from the group consisting of cyclosporine; and   an anesthetic.   
     
     
         31 .- 32 . (canceled) 
     
     
         33 . The ocular insert of  claim 24 , wherein the inner structure is selected from the group consisting of nylon, polymethyl methacrylate (PMMA), polycarbonate, polyethylene terepthalate, and polypropylene. 
     
     
         34 .- 35 . (canceled) 
     
     
         36 . The ocular insert of  claim 24 , wherein the inner structure has a diameter sized to fit on an anterior surface of the eye outside the optical zone of the cornea. 
     
     
         37 . The ocular insert of  claim 36 , wherein the diameter is at least 8 mm. 
     
     
         38 . The ocular insert of  claim 24 , wherein the insert is sized to fit on the sclera, fornix, or cul-de-sac of the eye. 
     
     
         39 . The ocular insert of  claim 24 , wherein the drug delivery matrix is a non-biodegradable material. 
     
     
         40 . The ocular insert of  claim 24 , wherein the drug delivery matrix is formed of a silicone polymer. 
     
     
         41 . The ocular insert of  claim 24 , wherein the outer edges and/or inner edges of the drug delivery matrix are shaped to inhibit friction between the outer edges and/or inner edges and a lid of the eye. 
     
     
         42 . The ocular insert of  claim 24 , wherein the anterior surface and/or posterior surface of the drug delivery matrix are shaped to the radius of the curvature of the eye. 
     
     
         43 . The ocular insert of  claim 24 , wherein the outer edges and/or inner edges of the drug delivery matrix are rounded in cross-section. 
     
     
         44 . The ocular insert of  claim 24 , wherein the outer edges and/or inner edges of the drug delivery matrix are beveled in cross-section. 
     
     
         45 . The ocular insert of  claim 24 , wherein the outer edges and/or inner edges of the drug delivery matrix are tapered in cross-section. 
     
     
         46 . The ocular insert of  claim 24 , wherein the one or more tubular segments of the drug delivery matrix surrounds discrete portions of the circumferential length. 
     
     
         47 . The ocular insert of  claim 24 , wherein a material of the inner structure and the drug delivery matrix have different durometers. 
     
     
         48 . The ocular insert of  claim 24 , wherein the insert is used to treat a condition selected from the group consisting of dry eye, glaucoma, allergies, infections, acne rosacea keratitis, cyclitis, blepharitis, diabetic retinopathy, age related macular degeneration, and amblyopia. 
     
     
         49 . (canceled) 
     
     
         50 . A method of treating an ocular condition with the ocular insert of  claim 24 , the method comprising:
 inserting the ocular insert on an anterior surface of the eye outside the optical zone of the cornea;   releasing the therapeutically effective quantity of the drug for the plurality of days; and   removing the ocular insert from the anterior surface of the eye after the plurality of days.   
     
     
         51 . (canceled) 
     
     
         52 . A non-corneal therapeutic system located outside of an optical zone of an eye capable of sustained release of one or more drugs to the eye for at least 30 days comprising:
 a first skeletal structure to attach, provide support, and maintain attachment of the therapeutic system of an anterior portion of the eye; and   a second structure, at least partially disposed along a length of the first structure, to provide cushioning to and a means of delivering at least one drug to the eye on at least one of the two structures.   
     
     
         53 . The system of  claim 52 , wherein the drug comprises one or more member selected from the group consisting of: steroids, anti-inflammatories, antibiotics, glaucoma treatment compounds, antihistamines, and/or dry eye medication. 
     
     
         54 . A method of treating an eye, the method comprising:
 placing a first structure on an anterior portion of the eye outside of an optical zone of the eye, wherein a second structure is at least partially disposed along a length of the first structure so as to provide cushioning to the eye;   releasing at least one drug from at least one of the first and second structures to the eye for a plurality of days; and   removing the first structure from the anterior surface of the eye after the plurality of days.