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(12) Patent Application Publication (10) Pub. No.: US 2011/0159073 A1 De Juan Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2011/0159073 A1 De Juan Et Al US 20110159073A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2011/0159073 A1 de Juan et al. (43) Pub. Date: Jun. 30, 2011 (54) METHODS AND DEVICES FOR THE Publication Classification TREATMENT OF OCULAR CONDITIONS (51) Int. Cl. (76) Inventors: Eugene de Juan, LaCanada, CA A6F 2/00 (2006.01) (US); Signe E. Varner, Los (52) U.S. Cl. ........................................................ 424/427 Angeles, CA (US); Laurie R. Lawin, New Brighton, MN (US) (57) ABSTRACT Featured is a method for instilling one or more bioactive (21) Appl. No.: 12/981,038 agents into ocular tissue within an eye of a patient for the treatment of an ocular condition, the method comprising con (22) Filed: Dec. 29, 2010 currently using at least two of the following bioactive agent delivery methods (A)-(C): (A) implanting a Sustained release Related U.S. Application Data delivery device comprising one or more bioactive agents in a (63) Continuation of application No. 1 1/175,850, filed on posterior region of the eye so that it delivers the one or more Jul. 5, 2005, now abandoned. bioactive agents into the vitreous humor of the eye; (B) instill ing (e.g., injecting or implanting) one or more bioactive (60) Provisional application No. 60/585,236, filed on Jul. 2, agents Subretinally; and (C) instilling (e.g., injecting or deliv 2004, provisional application No. 60/669,701, filed on ering by ocular iontophoresis) one or more bioactive agents Apr. 8, 2005. into the vitreous humor of the eye. Patent Application Publication Jun. 30, 2011 Sheet 1 of 22 US 2011/O159073 A1 Patent Application Publication Jun. 30, 2011 Sheet 2 of 22 US 2011/O159073 A1 Fig. 5 Patent Application Publication Jun. 30, 2011 Sheet 3 of 22 US 2011/O159073 A1 5 Patent Application Publication Jun. 30, 2011 Sheet 4 of 22 US 2011/O159073 A1 Patent Application Publication Jun. 30, 2011 Sheet 5 of 22 US 2011/O159073 A1 124 Fig. 9 Patent Application Publication Jun. 30, 2011 Sheet 6 of 22 US 2011/O159073 A1 4. 5 As 4. 145 As Patent Application Publication Jun. 30, 2011 Sheet 7 of 22 US 2011/O159073 A1 FORMRETINAL DETACHMENT . |-200 INSTILLBOACTIVE AGENT(S)N SUBRETINAL SPACE Fig. 14 INSTRUMENT(S)-302INSERT TARGET193ALZ519-304 SITE - | DETACHMENT9RMRNA-as INSILLBigAGLIVEaa AGENT (S N REMOVE L. 30 INSTRUMENT(s) OPTIONALLY INJECT BOACTIVE AGENTS) -312 INTO WIREOS MOR Fig. 15 Patent Application Publication Jun. 30, 2011 Sheet 8 of 22 US 2011/O159073 A1 s s e s s S S. s Patent Application Publication Jun. 30, 2011 Sheet 9 of 22 US 2011/O159073 A1 s Patent Application Publication Jun. 30, 2011 Sheet 10 of 22 US 2011/O159073 A1 INSTRUMENT(s)-352NSERT LocALIZE To 354. TARGET SITE FORINREriNA-356 OPENING XX-XXX- NSTLLBioACTIVE 358 AGENT(S) - SUBRETNA Y REMOVE 38 INSTRUMENT(s) optionALY, NJect ONE OR MORE BOACTIVE AGENTS INTo VTREOUS -35 OR Patent Application Publication Jun. 30, 2011 Sheet 11 of 22 US 2011/O159073 A1 40 Y. 48 44. A1 As ' ' -403 49 i-ra- Msta Y-4O7 4. 405 or ! (8 As -o- (7 s Fig. 20 Patent Application Publication Jun. 30, 2011 Sheet 12 of 22 US 2011/O159073 A1 Fig. 21 Patent Application Publication Jun. 30, 2011 Sheet 13 of 22 US 2011/O159073 A1 (ur) sseuxoa euge (Air) Sseuxou, eue Patent Application Publication Jun. 30, 2011 Sheet 14 of 22 US 2011/O159073 A1 -- r career a -8-2 r career Total drug oad: s 210mm diameter - 1.29 mg (s.d. iia) were 38EEE in arreter 250Miameter.360mm diameter - 4.3586 MGSNSmg (s.d. iia) S. 5 15 25 3. "ine (Days) Fig. 24 -- S - diaeter -8-5 in diarieter Total drug load. ck-3 if diarieter 150mm diameter - 1.50 mg (s.d. 0.06) arts -X-32 in diameter 320mm diameter - 5.33 mg (s.d. 0.15) 5 s 20 25 30 Time (Days) Patent Application Publication Jun. 30, 2011 Sheet 15 of 22 US 2011/O159073 A1 or or 8 in diarieter oSo is dieter sta cric. Cad: -a-320 um diameter 150mm diameter - 1.96 mg (s.d. 0.86) oxo-32 in diarieter 320mm diameter - 1.62 mg (s.d. 0.77) 5 5 2 25 30 irre (Days) A 3. Ca E Patent Application Publication Jun. 30, 2011 Sheet 16 of 22 US 2011/O159073 A1 Patent Application Publication Jun. 30, 2011 Sheet 17 of 22 US 2011/O159073 A1 Fig. 30 Patent Application Publication Jun. 30, 2011 Sheet 18 of 22 US 2011/O159073 A1 000\,00600800400-900900º00200Z00'? 000100600800100:900900°0?8QQz0){000109600800Z00:90000',00'? 000\,00600800.400900900:00,2002QQ! Patent Application Publication Jun. 30, 2011 Sheet 19 of 22 US 2011/O159073 A1 Fig. 33 Patent Application Publication Jun. 30, 2011 Sheet 20 of 22 US 2011/O159073 A1 Fig. 34 Patent Application Publication Jun. 30, 2011 Sheet 21 of 22 US 2011/O159073 A1 Scated age RENANESS Video intage Og Reflection hickass Cart Pescia r - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3G i. Patent Application Publication Jun. 30, 2011 Sheet 22 of 22 US 2011/O159073 A1 US 2011/O 159073 A1 Jun. 30, 2011 METHODS AND DEVICES FOR THE sive treatment. The procedure generally needs to be repeated TREATMENT OF OCULAR CONDITIONS every three months for at least two years, with approximate total cost of S12,250. CROSS-REFERENCE TO RELATED 0006. A number of angiostatic agents are currently under APPLICATIONS investigation for the treatment of AMD. Thalidomide, for example, is known to be a powerful angiostatic agent. Its 0001. This application is a continuation of U.S. applica systemic side effects, however, include peripheral neuropa tion Ser. No. 1 1/175,850, filed Jul. 5, 2005, entitled “METH thy, central nervous system depression, and embryotoxicity. ODS AND DEVICES FOR THE TREATMENT OF OCU In addition, these systemic side effects have limited the dos LAR CONDITIONS, which claims the benefit of U.S. age administered to patients for the treatment of Subretinal Provisional Application Ser. No. 60/585,236, filed Jul. 2, neovascularization. Systemic inhibition of angiogenesis in 2004, entitled “METHODS, DEVICES AND SYSTEMS older patients can also interfere with the development of FORTREATMENT OF OCULARDISEASES AND CON collateral circulation, which has a role in the prevention of DITIONS, and U.S. Provisional Application Ser. No. central nervous system as well as cardiac ischemic events. 60/669,701, filed Apr. 8, 2005, entitled “SUSTAINED 0007. A number of techniques or methodologies have DELIVERY DEVICES FOR THE CHOROID AND been developed to deliver drugs to the various tissues or RETINA AND METHODS FOR SUBRETINAL ADMIN structure that make up the mammalian eye, as described here ISTRATION OF BIOACTIVE AGENTS TO TREAT AND/ inafter, to treat a wide range of disorders or diseases of the OR PREVENT RETINAL DISEASES.” which applications eye. However, delivery of drugs, proteins and the like to the are incorporated herein by reference in their entirety. eye(s) of mammals in order to achieve the desired therapeutic or medical effect, especially to the retina and/or the choroid, FIELD has proved to be challenging, owing in large part to the geometry, delicacy and/or behavior of the eye and its compo 0002. The invention relates to methods and devices for the nents. A brief description of various conventional methods or treatment of ocular conditions. techniques for delivering drugs to the tissues of the eye and the shortcomings thereof is Summarized. BACKGROUND 0008 Oral ingestion of a drug or injection of a drug at a site other than the eye can provide a drug systemically, how 0003. There are a number of vision-threatening disorders ever such a systemic administration does not provide effec or diseases of the eye of a mammal including, but not limited tive levels of the drug specifically to the eye. In many oph to diseases of the retina, retinal pigment epithelium (RPE) thalmic disorders involving the retina, posterior tract, and and choroid. Such vision threatening diseases include ocular optic nerve, adequate levels of the drug cannot be achieved or neovascularization, ocular inflammation and retinal degen maintained by oral or parenteral routes of administration. erations. Examples of these disease states include diabetic Thus, further and repeated administration of the drug would retinopathy, chronic glaucoma, retinal detachment, sickle cell be necessary to achieve the desired or adequate levels of retinopathy, age-related macular degeneration, retinal concentration of the drug. Such further and repeated admin neovascularization, Subretinal neovascularization; rubeosis istrations of Such drugs may produce undesired systemic iritis inflammatory diseases, chronic posterior and pan uvei toxicity. tis, neoplasms, retinoblastoma, pseudoglioma, neovascular 0009 Ophthalmic conditions have also been treated using glaucoma; neovascularization resulting following a com drugs applied directly to the eye in either liquid or ointment bined vitrectomy-2 and lensectomy, vascular diseases, retinal form. This route of administration (i.e., topical administra ischemia, choroidal vascular insufficiency, choroidal throm tion) is only effective in treating problems involving the bosis, neovascularization of the optic nerve, diabetic macular superficial surface of the eye and diseases that involve the edema, cystoid macular edema, macular edema, retinitis pig cornea and anterior segment of the eye, Such as conjunctivitis. mentosa, retinal vein occlusion, proliferative vitreoretinopa Topical administration of drugs is not effective in achieving thy, angioid streak, and retinal artery occlusion, and neovas adequate concentrations of a drug(s) in the Sclera, vitreous, or cularization due to penetration of the eye or ocular injury. posterior segment of the eye. In addition, topical eye drops 0004 Age-related macular degeneration (AMD) is the may drain from the eye through the nasolacrimal duct and into leading cause of irreversible severe central vision loss in the systemic circulation, further diluting the medication and Caucasians fifty years old and older in the United States.
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