US2019321297A1PendingUtilityA1

Sustained delivery of therapeutic agents to an eye compartment

66
Assignee: UNIV JOHNS HOPKINSPriority: Feb 25, 2010Filed: Jul 3, 2019Published: Oct 24, 2019
Est. expiryFeb 25, 2030(~3.6 yrs left)· nominal 20-yr term from priority
Inventors:Peter J. McdonnellYasin A. KhanSamuel K. LaiRenata T. KashiwabuchiAshley BehrensJustin Hanes
A61P 27/00A61P 27/02A61K 9/1647A61K 9/5031A61K 9/1676A61K 31/519A61K 47/60A61K 9/5146A61K 47/6931A61K 31/52A61K 9/1641A61K 9/5026A61K 9/0048A61K 47/6921A61K 45/06A61K 9/5153A61K 9/0051A61K 47/58
66
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Claims

Abstract

Compositions and methods for treating eye disorders by administering a drug delivery system into an eye compartment of the patient, wherein the drug delivery system contains a particle containing a core; a coating associated with the particle, wherein the coating is covalently or non-covalently associated with the particle and presents a hydrophilic region to the environment around the particle; and a therapeutic agent are disclosed. The eye compartment can exhibit reduced inflammation or TOP after administration of the drug delivery systems to a patient than if a drug delivery system including an uncoated particle were administered to the patient.

Claims

exact text as granted — not AI-modified
1 - 60 . (canceled) 
     
     
         61 . An injectable composition for intravitreal injection into the vitreous chamber of the eye of a patient in need thereof, comprising microparticles in a sterile suspension suitable for intravitreal injection wherein the microparticles have a diameter of about 50 microns or less and comprise:
 (i) a core comprising a mixture of biodegradable polymers polylactide-co-glycolide and poly(lactic acid);   (ii) a coating non-covalently associated with the core wherein the coating is a block-copolymer having a hydrophilic region and a hydrophobic region and wherein the hydrophilic region is polyethylene glycol; and   (iii) a therapeutically effective amount of a therapeutic agent   
       wherein the injectable composition provides sustained release of the therapeutic agent into the eye compartment for at least two months and wherein the eye compartment exhibits at least 10% less inflammation or intraocular pressure than if the particle were uncoated for at least about 30 days post-administration. 
     
     
         62 . The injectable composition of  claim 61 , wherein the composition includes a suspending agent. 
     
     
         63 . The injectable composition of  claim 61 , wherein the therapeutic agent delivered is an anti-VEGF agent. 
     
     
         64 . The injectable composition of  claim 61 , wherein the therapeutic agent delivered is selected from timolol, betaxolol, bromonidine, and dorzolamide. 
     
     
         65 . The injectable composition of  claim 61 , wherein the injectable composition provides sustained release of the therapeutic agent into the vitreous chamber for at least three months. 
     
     
         66 . The injectable composition of  claim 61 , wherein the injectable composition provides sustained release of the therapeutic agent into the vitreous chamber for at least six months. 
     
     
         67 . The injectable composition of  claim 61 , wherein the injectable composition provides sustained release of the therapeutic agent into the vitreous chamber for at least nine months. 
     
     
         68 . The injectable composition of  claim 61 , wherein the microparticles have a diameter of about 30 microns or less. 
     
     
         69 . A drug delivery system for intravitreal injection into the vitreous chamber of the eye of a patient in need thereof, comprising a device containing a needle for injection and microparticles in a sterile suspension suitable for intravitreal injection wherein the microparticles have a diameter of about 50 microns or less and comprise:
 (i) a core comprising a mixture of biodegradable polymers polylactide-co-glycolide and poly(lactic acid);   (ii) a coating non-covalently associated with the core wherein the coating is a block-copolymer having a hydrophilic region and a hydrophobic region and wherein the hydrophilic region is polyethylene glycol; and   (iii) a therapeutically effective amount of a therapeutic agent   
       wherein the drug delivery system provides sustained release of the therapeutic agent into the eye compartment of the patient for at least two months and wherein the eye compartment exhibits at least 10% less inflammation or intraocular pressure than if the particle were uncoated for at least about 30 days post-administration. 
     
     
         70 . The drug delivery system of  claim 69 , wherein the composition includes a suspending agent. 
     
     
         71 . The drug delivery system of  claim 69 , wherein the therapeutic agent delivered is an anti-VEGF agent. 
     
     
         72 . The drug delivery system of  claim 69 , wherein the therapeutic agent delivered is selected from timolol, betaxolol, bromonidine, and dorzolamide. 
     
     
         73 . The drug delivery system of  claim 69 , wherein the drug delivery system provides sustained release of the therapeutic agent into the vitreous chamber of the eye for at least three months. 
     
     
         74 . The drug delivery system of  claim 69 , wherein the drug delivery system provides sustained release of the therapeutic agent into the vitreous chamber of the eye for at least six months. 
     
     
         75 . The drug delivery system of  claim 69 , wherein the drug delivery system provides sustained release of the therapeutic agent into the vitreous chamber of the eye for at least nine months. 
     
     
         76 . The drug delivery system of  claim 69 , wherein the microparticles have a diameter of about 30 microns or less. 
     
     
         77 . A method for the treatment of an eye disorder in a patient in need thereof comprising administering an injectable composition by intravitreal injection into the vitreous chamber, wherein the injectable composition comprises microparticles in a sterile suspension suitable for intravitreal injection wherein the microparticles have a diameter of about 50 microns or less and comprise:
 (i) a core comprising a mixture of biodegradable polymers polylactide-co-glycolide and poly(lactic acid);   (ii) a coating non-covalently associated with the core wherein the coating is a block-copolymer having a hydrophilic region and a hydrophobic region and wherein the hydrophilic region is polyethylene glycol; and   (iii) a therapeutically effective amount of a therapeutic agent   
       wherein the injectable composition provides sustained release of the therapeutic agent into the vitreous chamber for at least two months and wherein the vitreous chamber exhibits at least 10% less inflammation or intraocular pressure than if the particle were uncoated for at least about 30 days post-administration. 
     
     
         78 . The method of  claim 77 , wherein the disorder is macular degeneration. 
     
     
         79 . The method of  claim 77 , wherein the disorder is age-related macular degeneration. 
     
     
         80 . The method of  claim 77 , wherein the disorder is proliferative diabetic retinopathy. 
     
     
         81 . The method of  claim 77 , wherein the disorder is corneal neovascularization. 
     
     
         82 . The method of  claim 77 , wherein the patient is a human. 
     
     
         83 . The method of  claim 77 , wherein the microparticles have a diameter of about 30 microns or less. 
     
     
         84 . The method of  claim 77 , wherein the injectable composition provides sustained release of the therapeutic agent into the vitreous chamber of the eye for at least three months. 
     
     
         85 . The method of  claim 77 , wherein the injectable composition provides sustained release of the therapeutic agent into the vitreous chamber of the eye for at least six months. 
     
     
         86 . The method of  claim 77 , wherein the injectable composition provides sustained release of the therapeutic agent into the vitreous chamber of the eye for at least nine months.

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