Methods and devices for the treatment of ocular diseases in human subjects

Patent metadata

Field	Value
Publication number	US-9572800-B2
Application number	US-201615086485-A
Country	US
Kind code	B2
Filing date	Mar 31, 2016
Priority date	Nov 8, 2012
Publication date	Feb 21, 2017
Grant date	Feb 21, 2017

Abstract

Methods and devices are provided for targeted non-surgical administration of a drug formulation to the suprachoroidal space (SCS) of the eye of a human subject for the treatment of a posterior ocular disorder or a choroidal malady. In one embodiment, the method comprises inserting a hollow microneedle into the eye at an insertion site and infusing a drug formulation through the inserted microneedle and into the suprachoroidal space of the eye, wherein the infused drug formulation flows within the suprachoroidal space away from the insertion site during the infusion. In one embodiment, the fluid drug formulation comprises drug nanoparticles or microparticles.

First claim

The invention claimed is:

1. A method of treating a posterior ocular disorder in a human subject in need thereof, the method comprising,
non-surgically administering an effective amount of a drug formulation comprising axitinib to the suprachoroidal space (SCS) of the eye of the human subject in need of treatment of the posterior ocular disorder,
wherein upon administration, the drug formulation is substantially localized to the posterior segment of the eye.

2. The method of claim 1 , wherein the posterior ocular disorder is a choroidal malady, macular degeneration, macular edema, branch retinal vein occlusion, central retinal vein occlusion, retinopathy, diabetic retinopathy, retinal detachment, ocular neovascularization, eye cancer, or glaucoma.

3. The method of claim 2 , wherein the choroidal malady is choroidal neovascularization, subfoveal choroidal neovascularization, polypoidal choroidal vasculopathy, choroidal sclerosis, central sirrus choroidopathy, or multi-focal choroidopathy.

4. The method of claim 2 , wherein the macular degeneration is age-related macular degeneration, neovascular age-related macular degeneration, or subfoveal neovascular age related macular degeneration.

5. The method of claim 1 , wherein an effective amount of axitinib sufficient to elicit a therapeutic response when administered to the SCS is less than an effective amount of axitinib sufficient to elicit a therapeutic response when administered intravitreally, intracamerally, topically, parenterally or orally.

6. The method of claim 5 , wherein a dosage of axitinib sufficient to elicit a therapeutic response when administered to the SCS is 50% or less of a dosage of axitinib sufficient to elicit a therapeutic response when administered intravitreally, intracamerally, topically, parenterally or orally.

7. The method of claim 1 , wherein the retention of axitinib in the posterior segment of the eye is greater than the retention of axitinib in the posterior segment of the eye when axitinib is administered intravitreally, intracamerally, topically, parenterally or orally.

8. The method of claim 1 , wherein an intraocular C max of axitinib is greater than an intraocular C max of axitinib when axitinib is administered intravitreally, intracamerally, topically, parenterally or orally.

9. The method of claim 1 , wherein the systemic exposure of axitinib is less than the systemic exposure of axitinib when axitinib is administered intravitreally, intracamerally, topically, parenterally or orally.

10. The method of claim 1 , wherein the non-surgically administering includes conveying the effective amount of the drug formulation to the SCS via a microneedle having a length of from about 500 μm to about 1500 μm.

11. The method of claim 1 , wherein the drug formulation comprises a suspension of microparticles or nanoparticles.

12. The method of claim 11 , wherein the microparticles have a D 50 of 2 μm or less.

13. The method of claim 1 , wherein the intraocular pressure of the eye of the subject varies by no more than about 10% during the administration of the drug formulation.

Assignees

• Clearside Biomedical Inc

Inventors

• Zarnitsyn Vladimir
• Patel Samirkumar
• White Daniel
• Noronha Glenn
• Burke Brian
• Kissner Jennifer

Classifications

• C07K16/22

  against growth factors {; against growth regulators} · CPC title

• A61P27/10

  for accommodation disorders, e.g. myopia · CPC title

• A61P27/06

  Antiglaucoma agents or miotics · CPC title

• A61P27/02

  Ophthalmic agents · CPC title

• A61P25/00

  Drugs for disorders of the nervous system · CPC title