METHOD FOR DETERMINING OPTIMUM INTRAOCULAR LOCATIONS FOR DRUG DELIVERY IMPLANT

• US 20080181929A1
• Filed: 11/30/2007
• Published: 07/31/2008
• Est. Priority Date: 12/01/2006
• Status: Active Grant

• Current Assignee: Allergan Incorporated (Abbvie Incorporated)
• Original Assignee: Allergan Incorporated (Abbvie Incorporated)
• Inventors: Whitcup, Scott M., Hughes, Patrick M., Welty, Devin F., Chang-Lin, Joan-En, Robinson, Michael R.
• Granted Patent: US 8,571,802 B2
• Time in Patent Office: Days
• US Class Current: 424/427
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 39/3955 against proteinaceous materials, e.g. enzymes, hormones, lymphokines
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61P 27/02 Ophthalmic agents

Abstract

A method for determining the optimum location for placement of an intraocular implant containing used to treat an ocular condition, particularly implants comprised of a biodegradable polymer and a therapeutic agent for the treatment of retinal tissue.

Claims

1. A method for determining an optimum intravitreal location for a drug delivery system for treating an ocular condition, wherein the ocular condition affects a retinal tissue, and wherein the drug delivery system comprises a therapeutic agent and a biodegradable polymer associated with the therapeutic agent, the method comprising the step of determining the value of x in Formula (I):

C=C_oerfc[x/(2√

{square root over (Dt)})] 

 

(I)

wherein, C_o is the concentration of the therapeutic agent in retinal tissue adjacent to the implant, D is the coefficient for solution diffusion through the vitreous of the eye, t is time, erfc is the complementary error function, C is the desired concentration of the therapeutic agent in the retinal tissue, and x is the distance between the drug delivery system and the target retinal tissue, thereby determining the optimum intravitreal location for a drug delivery system for treating an ocular condition.

4. The method according to any one of claims 1-3, wherein said implant is implanted at or adjacent to the fovea of the eye.

5. The method according to any one of claims 1-4, wherein said ocular condition is macular edema or subfoveal choroidal neovascularization.

6. The method according to any one of claims 1-5, wherein said therapeutically active substance is a corticosteroid, an aminoglycoside or an anti-VGF antibody, wherein the corticosteroid is selected from the group consisting of fluocinolone, triamicinilone and dexamethasone.

7. The method according to claim 6, wherein said therapeutically active substance is at least one member selected from the group consisting of dexamethasone and fluocinolone, and said biodegradable polymeric material comprises at least one member selected from the group consisting of polylactides (PLA), polyglycolides (PGA), poly(lactide co-glycolide (PLGA), polycaprolactone, polyanhydride, poly methyl vinyl ether maleic anhydride, polycarbonates, polyarylates, polydioxanone, polyhydroxyalkanoates, and chitosan.

2. A method for treating an ocular condition with a drug delivery system, the drug delivery system comprising a therapeutic agent and a biodegradable polymer associated with the therapeutic agent, the ocular condition affecting a retinal tissue, the method comprising the steps of:

(a) determining the value of x in Formula (I);

C=C_oerfc[x/(2√

{square root over (Dt)})] 

 

(I)

 

wherein, C_o is the concentration of the therapeutic agent in a retinal tissue adjacent to the drug delivery system, D is the coefficient for solution diffusion through the vitreous of the eye, t is time, erfc is the complementary error function, C is a desired concentration of the therapeutic agent at the target retinal tissue affected by the ocular condition, and x is the distance between the implant and the target retinal tissue; and

(b) placing the drug delivery system in the vitreous at the position x thereby treating the ocular condition.

3. The method of claim 2, wherein the placing step is carried out using an applicator with a needle comprising a canula, in which canula the drug delivery system resides, wherein the needle has a length designed to permit placement of the drug delivery system into the vitreous at the position x.