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

Patent metadata

Field	Value
Publication number	US-9931330-B2
Application number	US-201715673073-A
Country	US
Kind code	B2
Filing date	Aug 9, 2017
Priority date	Nov 8, 2012
Publication date	Apr 3, 2018
Grant date	Apr 3, 2018

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 macular edema in a human subject in need thereof, the method comprising,
non-surgically administering an effective amount of a drug formulation comprising an anti-inflammatory drug to the suprachoroidal space (SCS) of the eye of the human subject in need of treatment of the macular edema; and
further comprising non-surgically administering a second drug to the eye of the subject, wherein the second drug comprises a vascular endothelial growth factor (VEGF) antagonist.

2. The method of claim 1 , wherein the macular edema is diabetic macular edema.

3. The method of claim 1 , wherein the VEGF antagonist is selected from a VEGF-receptor kinase antagonist, an anti-VEGF antibody or fragment thereof, an anti-VEGF receptor antibody, an anti-VEGF aptamer, a small molecule VEGF antagonist, a thiazolidinedione, a quinoline or a designed ankyrin repeat protein (DARPin).

4. The method of claim 1 , wherein the VEGF antagonist is aflibercept.

5. The method of claim 1 , wherein the anti-inflammatory drug is selected from mycophenolate, infliximab, nepafenac, azathioprine, cyclosphosphamide, dexamethasone, difluprednate, fluocinolone, fluorometholone, leteprednol, prednisolone acetate, prednisolone sodium phosphate, rimexolone, triamcinolone, bromfenac, diclofenac, fluibiprofen, ketorolac, adalimumab, etanercept, certolizumab, gotimumab, daclizumab, rituximab, abatacept, basiliximab, belimumab, anakinra, efalizuma, alefacept, and natalizumab.

6. The method of claim 1 , wherein the anti-inflammatory drug is triamcinolone.

7. The method of claim 1 , wherein the anti-inflammatory drug is triamcinolone acetonide.

8. The method of claim 1 , wherein the second drug is administered to the suprachoroidal space (SCS) of the eye of the subject.

9. The method of claim 1 , wherein the second drug is administered intravitreally in a second drug formulation.

10. The method of claim 1 , wherein the first drug and second drug are administered to the subject in one dosing session.

11. The method of claim 1 , wherein upon administration of the drug formulation to the SCS, the drug formulation flows away from the insertion site and is substantially localized to the posterior segment of the eye.

12. The method of claim 1 , wherein the macular edema is macular edema secondary to retinal vein occlusion.

Assignees

• Clearside Biomedical Inc

Inventors

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

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