Claims for Patent: 10,656,152

Summary for Patent: 10,656,152

Title:	Posterior segment drug delivery
Abstract:	A therapeutic device to release a therapeutic agent comprises a porous structure coupled to a container comprising a reservoir. The reservoir comprises a volume sized to release therapeutic amounts of the therapeutic agent for an extended time when coupled to the porous structure and implanted in the patient. The porous structure may comprise a first side coupled to the reservoir and a second side to couple to the patient to release the therapeutic agent. A plurality of interconnecting channels can extend from the first side to the second side so as to connect a first a plurality of openings on the first side with a second plurality of openings on the second side.
Inventor(s):	de Juan, Jr.; Eugene (Menlo Park, CA), Alster; Yair (Menlo Park, CA), Chamow; Steven M. (Menlo Park, CA), Farinas; Kathleen C. (Menlo Park, CA), Gifford, III; Hanson S. (Menlo Park, CA), Macfarlane; K. Angela (Menlo Park, CA), Reich; Cary J. (Menlo Park, CA), Barrett; Michael (Menlo Park, CA), Campbell; Randolph E. (Menlo Park, CA), George; Robert (Menlo Park, CA), Sutton; Douglas (Menlo Park, CA)
Assignee:	ForSight Vision4, Inc. (South San Francisco, CA)
Application Number:	15/807,396
Patent Claims:	1. A therapeutic device to treat an eye of a patient, the eye having a posterior segment and a sclera, the therapeutic device comprising: a rigid-walled, refillable reservoir having a volume, the reservoir adapted to reside in the posterior segment when the device is implanted in the eye; a rigid, porous structure located at a distal region of the reservoir comprising sintered material; a proximal cap portion positioned proximal of the reservoir and adapted to be positioned outside the sclera when the device is implanted in the eye, the cap portion comprising a retention structure and a penetrable, non-permeable barrier to introduce the therapeutic agent into the device without any need to explant the device during introduction of the therapeutic agent into the device; and a neck portion positioned between the cap portion and the reservoir portion and defined by a cross-sectional shape that is smaller than a cross-sectional shape of the reservoir and a cross-sectional shape of the cap portion, wherein the cross-sectional shape of the neck portion is non-circular and the cross-sectional shape of the reservoir is circular, and the sclera is positioned about the neck portion when the device is positioned in the eye. 2. The therapeutic device of claim 1, wherein the porous structure and reservoir chamber are tuned to release a predetermined rate profile of a particular therapeutic agent from the reservoir into the posterior segment to treat the eye for an extended period of time. 3. The therapeutic device of claim 1, wherein the volume of the refillable reservoir remains substantially unchanged and the rigid porous structure remains rigid when the reservoir is pressurized with injection of therapeutic agent into the reservoir. 4. The therapeutic device of claim 1, further comprising a porous, protective barrier configured to allow the therapeutic agent to pass from the reservoir through the protective barrier while inhibiting penetration of at least one of a bacterial cell or an immune cell through the protective barrier into the reservoir. 5. The therapeutic device of claim 1, wherein the device extends along an axis so as to extend through the sclera and a choroid into the posterior segment, and wherein the penetrable barrier of the proximal cap portion is located on a proximal end of the reservoir so as to allow refill of the reservoir with advancement of an injection needle through a conjunctiva and the penetrable barrier without the needle penetrating the sclera or choroid. 6. The therapeutic device of claim 1, wherein the sintered material of the rigid, porous structure comprises at least one of a metal, a ceramic, and a glass. 7. The therapeutic device of claim 1, wherein the sintered material comprises a plurality of irregularly shaped channels. 8. The therapeutic device of claim 7, wherein at least some of the plurality of irregularly shaped channels intersect at a plurality of locations. 9. The therapeutic device of claim 7, wherein the rigid, porous structure comprises a thickness and a surface area corresponding to a rate of release of the therapeutic agent over the extended time. 10. The therapeutic device of claim 9, wherein the thickness extends between a first side and a second side of the structure, and wherein the plurality of irregularly shaped channels extends between the first side and the second side and wherein the plurality of irregularly shaped channels have an effective length extending from the first side of the porous structure to the second side of the porous structure, the effective length greater than the thickness of said structure. 11. The therapeutic device of claim 1, wherein the porous structure comprises a porosity, a thickness, a channel parameter and a surface area configured to release therapeutic amounts for the extended period. 12. The therapeutic device of claim 11, wherein the channel parameter comprises a fit parameter corresponding to an effective length of a plurality of irregularly shaped channels extending from a first side of the porous structure to a second side of the porous structure. 13. The therapeutic device of claim 12, wherein the rate of release of the therapeutic agent through the porous structure corresponds to a ratio of the porosity to the channel parameter and wherein the ratio of the porosity to the channel parameter is less than about 0.5 such that the porous structure is capable of releasing the therapeutic agent for the extended period. 14. The therapeutic device of claim 1, wherein when implanted, the proximal cap portion is adapted to rest against and conform to a curvature of the sclera and to reside underneath a conjunctiva of the eye. 15. The therapeutic device of claim 1, wherein the therapeutic agent comprises a half-life within the reservoir of at least about 20 days when the device is implanted, and wherein the device is adapted to remain implanted in the eye and to treat the eye with the therapeutic agent for at least about 90 days. 16. The therapeutic device of claim 1, wherein the therapeutic agent comprises a half-life within the reservoir of at least about 30 days when implanted, and wherein the device is adapted to remain implanted in the eye and to treat the eye with the therapeutic agent for at least about 120 days. 17. The therapeutic device of claim 1, wherein the reservoir comprises a volume and the rigid porous structure comprises a release rate adapted to provide the therapeutic agent with a half-life within the reservoir when implanted into the eye, the half-life within the reservoir substantially greater than a corresponding half-life of the therapeutic agent when injected directly into the vitreous and the half-life within the reservoir corresponding to release of therapeutic amounts for at least about 120 days. 18. The therapeutic device of claim 1, wherein the porous structure comprises a release rate index of no more than about 5.0 mm. 19. The therapeutic device of claim 1, wherein the volume of the reservoir is sized to contain the quantity of the therapeutic agent for release over a predetermined extended time and wherein the rigid, porous structure comprises a thickness and a surface area corresponding to a rate of release of the therapeutic agent and wherein the volume and the rate of release correspond to a half-life of the therapeutic agent in the reservoir. 20. The device of claim 1, wherein the rigid porous structure comprises a first side having a first area, a second side having a second area corresponding substantially to the first area, a thickness extending between the first side and the second side, a porosity, and a channel parameter corresponding to a release of the therapeutic agent from the reservoir to the posterior segment of the eye. 21. The therapeutic device of claim 1, wherein the particular therapeutic agent comprises a molecular weight within a range from 100 Daltons to about 1,000,000 Daltons and wherein the molecular weight corresponds to the predetermined release rate profile. 22. The therapeutic device of claim 1, wherein the particular therapeutic agent comprises one or more compounds of 2-Methoxyestradiol analogs, 3-aminothalidomide, 13-cis retinoic acid, A0003, A5b1 integrin inhibitor, Abarelix, Abatacept, Abciximab, ABT-578, Acetonide, Adalimumab, Aldesleukin, Alefacept, Alemtuzumab, Alpha-1-proteinase inhibitor, Alteplase, AMG-1470, Anakinra, Anecortave acetate, Angiostatin, Anistreplase, Anti-angiogenesis peptides, Anti-angiogenesis antibodies, TRC093, TRC 105, Anti-angiogeric bifunctional protein, Anti-endothelial growth factor, Antihemophilic Factor, Antithymocyte globulin, Anti-hypertensive MC1101, Anti-platelet devired growth factor, Anti-VEGF, AP23841, Aprotinin, Arcitumomab, Asparaginase, Axitinib, Basiliximab, Becaplermin, Bevacizumab, Bivalirudin, Bortezomib, Bosutinib, Botulinum Toxin Type A, Botulinum Toxin Type B, C5 inhibitor, Canstatin, Capromab, Captopril, CCI-779, Cediranib, Celecoxib, Cetrorelix, Cetuximab, Choriogonadotropin alfa, Cilary neurotrophic factor, Coagulation Factor IX, Coagulation factor VIIa, Colchicines, Collagenase, Complement factor H recombinant, Compstatin derivative peptide, POT-4, Corticotropin, Cosyntropin, Cyclophilins, Cyclosporine, Daclizumab, Darbepoetin alfa, Dasatinib, Defibrotide, Denileukin diftitox, Desmopressin, Dexamethasone, Diclofenac, Dithiocarbamate, Dornase Alfa, Drotrecogin alfa, Eculizumab, Efalizumab, Endostatin, Enfuvirtide, Epoetin alfa, Eptifibatide, Erlotinib, Etanercept, Everolimus, Exenatide, Felypressin, Fenretinide, Filgrastim, FK605-binding proteins, FKBPs, Fluocinolone Acetonide, Follitropin beta, Fumagillin, Galsulfase, Gefitinib, Gemtuzumab ozogamicin, Glatiramer Acetate, Glucagon recombinant, Goserelin, Human Serum Albumin, Hyaluronidase, Ibritumomab, Idursulfase, Imatinib, Immune globulin, Infliximab, Insulin Glargine recombinant, Insulin Lyspro recombinant, Insulin recombinant, Insulin, porcine, Interferon, Interferon Alfa-2a, Recombinant, Interferon Alfa-2b, Recombinant, Interferon alfacon-1, Interferon alfa-n1, Interferon alfa-n3, Interferon beta-1b, Interferon gamma-1b, Lapatinib, Lepirudin, Lestaurtinib, Leuprolide, Lutropin alfa, Mecasermin, Menotropins, mTOR inhibitors, Muromonab, Natalizumab, Nepafenac, Nesiritide, Nilotinib, NS398, Octreotide, Omalizumab, Oprelvekin, OspA lipoprotein, OT-551, Oxytocin, Palifermin, Palivizumab, Panitumumab, PDGF inhibitor, PEDF (pigment epithelium derived factor), Pegademase bovine, Pegaptanib, Pegaspargase, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Pegvisomant, Pentoxifylline, Perindozril, Pimecrolimus, PKC (protein kinase C) inhibitors, Pramlintide, Proteosome inhibitors, Pyrrolidine, Quinopril, Ranibizumab, Rapamycin (siroliums), Rasburicase, Reteplase, Retinal stimulant, Retinoid(s), Rituximab, RNAI (RNA interference of angiogenic factors), Rofecoxib, Rosiglitazone, Ruboxistaurin, Salmon Calcitonin, Sargramostim, SDZ-RAD, Secretin, Selective inhibitor of the factor 3 complement cascade, Selective inhibitor of the factor 5 complement cascade, Semaxanib, Sermorelin, Serum albumin iodinated, Siroliums reformulation (rapamycin), siRNAi molecule synthetic, FTP-801i-14, Somatropin recombinant, Squalamine, Streptokinase, Sunitinib, Tacrolimus, Tenecteplase, Teriparatide, Tetrathiomolybdate, Thyrotropin Alfa, Tie-1 and Tie-2 kinase inhibitors, Toceranib, Tositumomab, TPN 470 analogue, Trastuzumab, Triamcinolone acetonide, Troglitazone, Tumistatin, Urofollitropin, Urokinase, Vandetanib, Vasopressin, Vatalanib, VEGF receptor kinase inhibitor, VEGF Trap, Visual Cycle Modulator ACU-4229, Vitamin(s), Vitronectin receptor antagonists, or Volociximabe. 23. The therapeutic device of claim 1, wherein the cross-sectional shape of the neck portion complements a shape of an incision through which the device is positioned in the eye. 24. The therapeutic device of claim 1, wherein the cross-sectional shape of the cap portion is circular. 25. The therapeutic device of claim 1, wherein the cross-sectional shape of the neck portion is an oval or an ellipse. 26. The therapeutic device of claim 1, wherein the cross-sectional shape of the neck portion comprises a first curve along a first axis and a second curve along a second axis that is different than the first curve. 27. A kit comprising the therapeutic device of claim 1, further comprising a needle coupled to a fill syringe. 28. The kit of claim 27, wherein the needle comprises a stop configured to prevent a tip of the needle from advancing into the reservoir of the therapeutic device beyond a maximum stop distance. 29. The kit of claim 27, further comprising a placement instrument.

Details for Patent 10,656,152

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Emd Serono, Inc.	PERGONAL	menotropins	For Injection	017646	08/22/1975		2029-01-29
Emd Serono, Inc.	PERGONAL	menotropins	For Injection	017646	05/20/1985		2029-01-29
Eli Lilly And Company	HUMATROPE	somatropin	For Injection	019640	06/23/1987		2029-01-29