Claims for Patent: 9,999,595

Summary for Patent: 9,999,595

Title:	Eye device
Abstract:	The invention provides a sustained release intraocular drug delivery device comprising: (a) a polymeric matrix core into which at least one therapeutic agent is mixed, and; (b) a polymeric coating completely surrounding said polymeric matrix material; wherein said polymeric matrix core and polymeric coating are insoluble and inert in ocular fluids, and wherein said sustained release intraocular drug delivery device has a compliant annular segment shape and is to be inserted into the sulcus of the intact and/or pseudophakic eye.
Inventor(s):	Rakic; Jean-Marie (Havelange, BE), Foidart; Jean-Michel (Trooz, BE)
Assignee:	EYED PHARMA (Liege, BE)
Application Number:	15/034,869
Patent Claims:	1. A sustained release intraocular drug delivery device having the shape of a compliant annular segment configured for a sulcus of a human eye, comprising: (a) an annular rod shaped solid polymeric matrix core into which at least one therapeutic agent is mixed, and; (b) a solid polymeric coating completely surrounding said polymeric matrix material; wherein said polymeric matrix core and polymeric coating are insoluble and inert in ocular fluids, and wherein said sustained release intraocular drug delivery device has a cross sectional diameter ranging from 0.10 to 0.80 mm, wherein the annular segment ranges from 90 to 360 degrees of the ring; and wherein the polymeric coating regulates the release of the therapeutic agent contained in the polymeric matrix material. 2. The device according to claim 1, wherein said polymeric matrix core has a cross-sectional diameter of 0.1 mm to 0.48 mm. 3. The device according to claim 1, wherein said polymeric coating is a polymeric membrane with a thickness ranging from 0.05 to 0.32 mm. 4. The device according to claim 1, wherein said annular segment has length configured to extend along from 180 to 360.degree. of the sulcus. 5. The device according to claim 1, wherein said polymeric matrix core comprises a polymer selected from the group consisting of ethylene-co-vinylacetate, poly(dimethylsiloxane), polypropylene, high density polyethylene, plasticized polyethylene terephthalate, poly(methyl methacrylate), polyvinyl acetate, cross-linked polyvinyl alcohol, cross-linked polyvinyl butyrate, ethylene ethylacrylate copolymer, polyethyl hexylacrylate, polyvinyl chloride, polyvinyl acetals, polyvinyl alcohol, polyvinyl acetate, ethylene vinylchloride copolymer, polyvinyl esters, polyvinylbutyrate, polyvinylformal, polyamides, polymethylmethacrylate, polybutylmethacrylate, plasticized polyvinyl chloride, plasticized nylon, plasticized soft nylon, natural rubber, polyisoprene, polyisobutylene, polybutadiene, polyethylene, polytetrafluoroethylene, polyvinylidene chloride, polyacrylonitrile, cross-linked polyvinylpyrrolidone, polytrifluorochloroethylene, chlorinated polyethylene, poly(1,4-isopropylidene diphenylene carbonate), vinylidene chloride, acrylonitrile copolymer, vinyl chloride-diethyl fumerale copolymer, silicone rubbers, ethylene-propylene rubber, silicone-carbonate copolymers, vinylidene chloride-vinyl chloride copolymer, vinyl chloride-acrylonitrile copolymer and vinylidene chloride-acrylonitride copolymer, polycarbonate, polyurethane, thermoplastic elastomers (TPE), SEBS (styrene-ethylene-butylene-styrene), SBS (styrene-butadiene-styrene), MBM (methylmethacrylate-butadiene-methylmethacrylate)), and combinations thereof. 6. The device according to claim 5, wherein said polymeric matrix core comprises a polymer selected from the group consisting of high density polyethylene, poly(methyl methacrylate), and combinations thereof. 7. The device according to claim 5, wherein said polymeric matrix core comprises from 1.0 to 50% by weight of said at least one therapeutic agent. 8. The device according to claim 5, wherein said polymeric coating comprises a polymer selected from the group consisting of ethylene-co-vinylacetate, poly(dimethylsiloxane), polypropylene, polyethylene, plasticized polyethylene terephthalate, poly(methyl methacrylate), crosslinked polyvinyl alcohol, polyolefins or polyvinyl chlorides or cross-linked gelatins; regenerated, insoluble, nonerodible cellulose, acylated cellulose, esterified celluloses, cellulose acetate propionate, cellulose acetate butyrate, cellulose acetate phthalate, cellulose acetate diethyl-aminoacetate; polyurethanes, polycarbonates, and microporous polymers formed by co-precipitation of a polycation and a polyanion modified insoluble collagen, and combinations thereof. 9. The device according to claim 8, wherein said polymeric coating comprises a polymer selected from the group consisting of polyethylene, high density polyethylene, poly(methyl methacrylate), and combinations thereof. 10. The device according to claim 1, wherein said polymeric matrix core comprises a polymer selected from the group consisting of high density polyethylene, poly(methyl methacrylate), and combinations thereof; wherein said polymeric coating comprises a polymer selected from the group consisting of high density polyethylene, poly(methyl methacrylate), and combinations thereof; wherein said at least one therapeutic agent is selected from the group consisting of antibiotic agents, antibacterial agents, antiviral agents, prostaglandin analogues, anti-glaucoma agents, antiallergenic agents, anti-inflammatory agents, anti-angiogenesis agents, immune system modifying agents, anti-cancer agents, antisense agents, antifungal agents, myotic and anticholinesterase agents, mydriatic agents, differentiation modulator agents, sympathomimetic agents, anaesthetic agents, vasoconstrictive agents, vasodillatory agents, decongestants, cell transport/mobility impending agents, polypeptides and protein agents, steroidal agents, carbonic anhydrase inhibitor agents, polycations, polyanions, and lubricating agents. 11. The device according to claim 10, wherein said at least one therapeutic agent is selected from the group consisting of prostaglandin analogues, anti-glaucoma agents, anti-inflammatory agents, anti-angiogenesis compounds, and immune system modifying agents. 12. The device according to claim 10, wherein said at least one therapeutic agent is selected from the group consisting of bevacizumab, ranibizumab, aflibercept, timolol, latanoprost, dorzolamide, triamcinolone, dexamethasone, and cyclosporin. 13. The device according to claim 4, wherein said polymeric matrix core comprises polyethylene, and wherein said polymeric coating comprises polyethylene, high density polyethylene, or poly(methyl methacrylate). 14. The device according to claim 4, wherein said polymeric matrix core comprises poly(methyl methacrylate), and wherein said polymeric coating comprises polyethylene, high density polyethylene, or poly(methyl methacrylate). 15. The device according to claim 13, wherein said at least one therapeutic agent comprises timolol. 16. A method of treatment of ocular diseases comprising administering a therapeutic agent incorporated within a sustained release intraocular drug delivery device according to claim 1, and wherein said sustained release intraocular drug delivery device is inserted into the sulcus of the human eye. 17. The method of treatment according to claim 16, wherein the therapeutic agent is selected from the group consisting of: bevacizumab, ranibizumab, aflibercept, timolol, latanoprost, dorzolamide, triamcinolone, dexamethasone, and cyclosporine. 18. The method according to claim 17, wherein said therapeutic agent is selected from the group consisting of: timolol, triamcinolone, dexamethasone, and cyclosporine. 19. A process for preparing a sustained release intraocular drug delivery device, comprising: mixing the at least one therapeutic agent with an insoluble and inert polymer; molding and/or extruding said mixture to form a solid polymeric matrix core; and, providing the resulting polymeric matrix core with a polymeric coating, wherein the polymeric coating is a solid and completely surrounding said polymeric matrix material; wherein said polymeric matrix core and polymeric coating are insoluble and inert in ocular fluids, and wherein said sustained release intraocular drug delivery device forms a compliant annular segment having a cross sectional diameter ranging from 0.10 to 0.80 mm and length sufficient to extend along 90 to 360 degrees of the sulcus of the human eye. 20. The process of claim 19, wherein the step of providing the resulting polymer matrix core with a polymeric coating is performed by covering said resulting polymeric matrix core with a polymeric membrane in a mold, and heating said mold. 21. The process according to claim 20, for use in manufacturing an intraocular device for the treatment of ocular diseases by inserting said device in the sulcus of the eye. 22. A surgical method for inserting or implanting the device according to claim 1, comprising the steps of partially straightening the device by applying force, inserting the device in the sulcus of the human eye, and releasing said device. 23. The device according to claim 1, wherein the said polymeric matrix core comprises a polymer selected from the group of ethylene-co-vinylacetate, a polyurethane, a polyolefin, and combinations thereof; wherein said polymeric coating comprises a polymer selected from the group of ethylene-co-vinylacetate, a polyurethane, a polyolefin, and combinations thereof; and wherein said at least one therapeutic agent is selected from the group consisting of antibiotic agents, antibacterial agents, antiviral agents, prostaglandin analogues, anti-glaucoma agents, antiallergenic agents, anti-inflammatory agents, anti-angiogenesis agents, immune system modifying agents, anti-cancer agents, antisense agents, antifungal agents, myotic and anticholinesterase agents, mydriatic agents, differentiation modulator agents, sympathomimetic agents, anaesthetic agents, vasoconstrictive agents, vasodillatory agents, decongestants, cell transport/mobility impending agents, polypeptides and protein agents, steroidal agents, carbonic anhydrase inhibitor agents, polycations, polyanions, and lubricating agents. 24. The device according to claim 23, wherein said at least one therapeutic agent is selected from the group consisting of prostaglandin analogues, anti-glaucoma agents, anti-inflammatory agents, anti-angiogenesis compounds, and immune system modifying agents. 25. The device according to claim 23, wherein said at least one therapeutic agent is selected from the group consisting of bevacizumab, ranibizumab, aflibercept, timolol, latanoprost, dorzolamide, triamcinolone, dexamethasone, and cyclosporin. 26. The device according to claim 1, wherein said polymeric matrix core comprises polyethylene, ethylene-co-vinylacetate, a polyurethane, or a polyolefin, and wherein said polymeric coating comprises polyethylene, high density polyethylene, poly(methyl methacrylate), ethylene-co-vinylacetate, a polyurethane, or a polyolefin. 27. The device according to claim 1, wherein said polymeric matrix core comprises poly(methyl methacrylate), ethylene-co-vinylacetate, a polyurethane, or a polyolefin, and wherein said polymeric coating comprises polyethylene, high density polyethylene, poly(methyl methacrylate), ethylene-co-vinylacetate, a polyurethane, or a polyolefin. 28. The device according to claim 26, wherein said at least one therapeutic agent comprises timolol. 29. A method of treatment of ocular diseases comprising administering a therapeutic agent incorporated within a sustained release intraocular drug delivery device according to claim 23, and wherein said sustained release intraocular drug delivery device is inserted into the sulcus of the human eye. 30. The method of treatment according to claim 29, wherein the therapeutic agent is selected from the group consisting of: bevacizumab, ranibizumab, aflibercept, timolol, latanoprost, dorzolamide, triamcinolone, dexamethasone, and cyclosporine.

Details for Patent 9,999,595

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004		2033-11-14
Genentech, Inc.	LUCENTIS	ranibizumab	Injection	125156	06/30/2006		2033-11-14
Genentech, Inc.	LUCENTIS	ranibizumab	Injection	125156	08/10/2012		2033-11-14
Genentech, Inc.	LUCENTIS	ranibizumab	Injection	125156	10/13/2016		2033-11-14
Genentech, Inc.	LUCENTIS	ranibizumab	Injection	125156	03/20/2018		2033-11-14
Regeneron Pharmaceuticals, Inc.	EYLEA	aflibercept	Injection	125387	11/18/2011		2033-11-14