(12) Patent Application Publication (10) Pub. No.: US 2013/0302324 A1 Whitcup Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2013/0302324 A1 Whitcup Et Al US 2013O3O2324A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2013/0302324 A1 Whitcup et al. (43) Pub. Date: Nov. 14, 2013 (54) METHODS FORTREATING RETINOPATHY abandoned, Continuation-in-part of application No. WITH EXTENDED THERAPEUTIC EFFECT 10/837,357, filed on Apr. 30, 2004, now abandoned. (71) Applicant: Allergan, Inc., Irvine, CA (US) Publication Classification (72) Inventors: Scott M. Whitcup, Laguna Hills, CA (51) Int. Cl. (US); David A. Weber, Danville, CA A619/00 (2006.01) (US) A 6LX39/395 (2006.01) (52) U.S. Cl. (21) Appl. No.: 13/946,294 CPC ........... A61K 9/0051 (2013.01); A61K.39/3955 (2013.01) (22) Filed: Jul.19, 2013 USPC ....................................................... 424/133.1 Related U.S. Application Data (57) ABSTRACT (63) Continuation of application No. 13/604.809, filed on Methods for treating and preventing retinopathic conditions Sep. 6, 2012, now abandoned, Continuation of appli by administering a glucocorticoid to the vitreous chamber of cation No. 1 1/292,544, filed on Dec. 2, 2005, now a patient at risk of, or Suffering from, the retinopathy. Patent Application Publication Nov. 14, 2013 Sheet 1 of 3 US 2013/0302324 A1 GURE Witress is or Coacetrations of exarethase is Treated Eye: Coaparison of ai ibose eyes and sage Fores OO axxaasaas Nym 350 " wŠw it - - - Quantificatio Limit 35E GE Perces of Bexarethasosie Reseased fross EXES Soyer Tire for a lose Leveis and Bosage Forss 50 ................................ - S axxxxxxxS& 8 Šwice. --- ---------------------------------- are: s w 8&aYSSYYYYYYYYYY ways& s swy & 35 y^arraxswwsS&--------- -aaaasra S *\\\8. $35 s s 8 s xxxoxxxxxxoxxxxxoxxxxxarxxxxxraxxxxxroxoto350E 2 3. z 5 { 3. Patent Application Publication Nov. 14, 2013 Sheet 2 of 3 US 2013/0302324 A1 GURE 3 Wirects issor Coacetratio as of exaggethias.bgae is a treated Eye: Caparisca of a base Leveis a bosage creas assassacreas ----------- sexes xx35' 00 ------- ------- ... it wasm 7(0T b - - - Quantification init 1 co-hoo-350E ------------ e arra-Maaaaa-Ms {} 0 20 30 43 53 63 70 80 90 Bays F83. 48 Perce of exaggetikasore seleased free EXPS-2S verise for asse350E {} 3. 4} 5) 5. f SO 90 Days Patent Application Publication Nov. 14, 2013 Sheet 3 of 3 US 2013/0302324 A1 F.G. 5 US 2013/0302324 A1 Nov. 14, 2013 METHODS FOR TREATING RETINOPATHY dysfunction, retinitis pigmentosa and glaucoma. Glaucoma WITH EXTENDED THERAPEUTIC EFFECT can be considered a posterior ocular condition because the therapeutic goal is to prevent the loss of or reduce the occur CROSS REFERENCE rence of loss of vision due to damage to or loss of retinal cells or retinal ganglion cells (i.e. neuroprotection). 0001. The present application is a continuation of U.S. 0005. An anterior ocular condition can include a disease, patent application Ser. No. 13/604.809, filed on Sep. 6, 2012, ailment or condition, such as for example, aphakia; which is a continuation of U.S. patent application Ser. No. pseudophakia; astigmatism; blepharospasm; cataract; con 11/292,544, filed Dec. 2, 2005, now abandoned, which is a junctival diseases; conjunctivitis; corneal diseases, corneal continuation in part of U.S. patent application Ser. No. ulcer, dry eye syndromes; eyelid diseases; lacrimal apparatus 10/837,357, filed Apr. 30, 2004, now abandoned, the entire diseases; lacrimal duct obstruction; myopia; presbyopia; content of which is expressly incorporated by reference hyperopia; pupil disorders; refractive disorders and Strabis herein. The entire disclosure of U.S. patent application Ser. mus. Glaucoma can also be considered to be an anterior No. 13/604.809 is incorporated herein by reference. ocular condition because a clinical goal of glaucoma treat ment can be to reduce a hypertension of aqueous fluid in the BACKGROUND anterior chamber of the eye (i.e. reduce intraocular pressure). 0002. This invention relates to methods for extended treat 0006. The present invention is directed to a method for ment of an ocular condition. In particular the present inven providing an extended treatment of an ocular condition, Such tion releases to methods for extended treatment of an ocular as an anterior ocular condition or a posterior ocular condition condition with an intraocular implant. or to an ocular condition which can be characterized as both 0003. An ocular condition can include an inflammatory, an anterior ocular condition and a posterior ocular condition. neoplastic, infectious, vascular, neovascular and/or degenera 0007. Therapeutic compounds useful for the treatment of tive disease, aliment or condition which affects or involves an ocular condition can include cytokines and active agents the eye or one of the parts or regions of the eye. Broadly with, for example, an anti-neoplastic (i.e. anti-cancer), anti speaking the eye includes the eyeball and the tissues and angiogenesis, kinase inhibition, anticholinergic, anti-adren fluids which constitute the eyeball, the periocular muscles ergic and/or anti-inflammatory activity. (such as the oblique and rectus muscles) and the portion of the 0008 Macular degeneration, such as age related macular optic nerve which is within or adjacent to the eyeball. An degeneration (AMD) is a leading cause of irreversible anterior ocular condition is a disease, ailment or condition vision loss in elderly populations. It is estimated that thirteen which affects or which involves an anterior (i.e. front of the million Americans have evidence of macular degeneration. eye) ocular region, location or site (hereafter an ocular site), Macular degeneration results in a break down or injury to the Such as a periocular muscle, an eyelid or an eyeball tissue or macula, the central part of the retina responsible for the sharp, fluid which is located anterior to the posterior wall of the lens direct vision needed to read or drive. Central vision is espe capsule or ciliary muscles. Thus, an anterior ocular condition cially or selectively affected. Macular degeneration is diag primarily affects or involves, the conjunctiva, the cornea, the nosed as either dry or wet (exudative). The dry form of macu anterior chamber, the iris, the posterior chamber (behind the lar degeneration is more common than the wet form of iris but in front of the posterior wall of the lens capsule), the macular degeneration, with about 90% of AMD patients lens or the lens capsule and blood vessels and nerve which being diagnosed with dry AMD. The wet form of the disease vascularize or innervate an anterior ocular region or site. A usually leads to more rapid and more serious vision loss. posterior ocular condition is a disease, ailment or condition Macular degeneration can produce a slow or Sudden painless which primarily affects or involves a posterior ocular site loss of vision. The cause of macular degeneration is not clear. Such as choroid or Sclera (in a position posterior to a plane The dry form of AMD may result in thinning of macular through the posterior wall of the lens capsule), vitreous, vit tissues, depositing of pigment in the macula, or a combination reous chamber, retina, optic nerve (including the optic disc), of the two processes. With wet AMD, new blood vessels grow and blood vessels and nerves which vascularize or innervate within and beneath the retina and leak blood and fluid. This a posterior ocular site. leakage causes injury to retinal cells and creates blind spots in 0004 Thus, a posterior ocular condition can include a central vision. disease, ailment or condition, such as for example, macular 0009 Macular edema (ME) can result in a swelling or degeneration (such as non-exudative age related macular thickening of the macular and appears to be a nonspecific degeneration and exudative age related macular degenera response of the retina to a variety of insults. Thus, ME is tion); macular hole; light, radiation or thermal damage to a associated with a number of diseases, including anterior or posterior ocular tissue; choroidal neovascularization; acute posterior uveitis, retinal vascular abnormalities (diabetic ret macular neuroretinopathy; macular edema (such as cystoid inopathy and retinal venous occlusive disease), as a sequela of macular edema and diabetic macular edema); Behcet’s dis cataract Surgery (Irvine-Gass Syndrome), macular degenera ease, retinal disorders, diabetic retinopathy (including prolif tion, vitreo-macular traction syndrome, inherited or acquired erative diabetic retinopathy); retinal arterial occlusive dis retinal degeneration, eye inflammation, idiopathic central ease; central retinal vein occlusion: uveitic retinal disease; serous chorioretinopathy, pars planitis, retinitis pigmentosa, retinal detachment; ocular trauma which affects a posterior radiation retinopathy, posterior vitreous detachment, epireti ocular site; a posterior ocular condition caused by or influ nal membrane formation, idiopathic juxtafoveal retinal enced by an ocular laser treatment; posterior ocular condi telangiectasia, following Nd:YAG capsulotomy or iridotomy. tions caused by or influenced by a photodynamic therapy: Some patients with ME may have a history of use of topical photocoagulation; radiation retinopathy; epiretinal mem epinephrine or prostaglandin analogs for glaucoma. Macular brane disorders; branch retinal vein occlusion; anterior edema involves the development of microangiopathy, char ischemic optic neuropathy; non-retinopathy diabetic retinal acterized by abnormal retinal vessel permeability and capil US 2013/0302324 A1 Nov. 14, 2013 lary leakage into the adjacent retinal tissues. The
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