Methods and formulations for treating vascular eye diseases using aflibercept and nesvacumab

Patent metadata

Field	Value
Publication number	US-11071780-B2
Application number	US-201816235221-A
Country	US
Kind code	B2
Filing date	Dec 28, 2018
Priority date	Nov 25, 2014
Publication date	Jul 27, 2021
Grant date	Jul 27, 2021

Abstract

The present invention provides methods for treating, preventing or reducing the severity of an eye disease. The methods of the present invention comprise administering to a subject in need thereof a therapeutic composition comprising an angiopoietin-2 (Ang-2) inhibitor such as an anti-Ang-2 antibody in combination with a vascular endothelial growth factor (VEGF) antagonist (e.g., aflibercept).

First claim

What is claimed is:

1. A method for treating a vascular eye disease or disorder, in a human subject in need thereof, comprising intravitreally administering 2 mg aflibercept and 6 mg nesvacumab in a pharmaceutical composition comprising
(i) 40 mg/ml of aflibercept;
(ii) 120 mg/ml of nesvacumab;
(iii) a sodium phosphate buffer at pH of 6.2±0.3;
(iv) polysorbate 20;
(v) sodium chloride; and
(vi) sucrose,
to the subject.

2. The method of claim 1 , wherein the pharmaceutical composition is administered to the subject every 4 weeks.

3. The method of claim 1 , wherein the eye disease or disorder is selected from the group consisting of diabetic retinopathy, diabetic macular edema, age-related macular degeneration, retinal neovascularization, central retinal vein occlusion, branched retinal vein occlusion, polypoidal choroidal vasculopathy, and choroidal neovascularization.

4. The method of claim 3 , wherein the eye disease or disorder is age-related macular degeneration.

5. The method of claim 3 , wherein the eye disease or disorder is diabetic macular edema.

6. A method for inhibiting retinal angiogenesis, inhibiting retinal neovascularization, inhibiting vascular leak and/or suppressing vascular leak, in a human subject in need thereof, comprising intravitreally administering 2 mg aflibercept and 6 mg nesvacumab in a pharmaceutical composition comprising
(i) 40 mg/ml of aflibercept;
(ii) 120 mg/ml of nesvacumab;
(iii) a sodium phosphate buffer at pH of 6.2±0.3;
(iv) polysorbate 20;
(v) sodium chloride; and
(vi) sucrose,
to the subject.

7. The method of claim 6 , wherein the retinal angiogenesis, retinal neovascularization, or vascular leak is associated with an eye disease or disorder selected from the group consisting of diabetic retinopathy, diabetic macular edema, age-related macular degeneration, retinal neovascularization, central retinal vein occlusion, branched retinal vein occlusion, polypoidal choroidal vasculopathy, and choroidal neovascularization.

8. The method of claim 6 , wherein the pharmaceutical formulation is intravitreally administered to the subject every 4 weeks.

9. A method for treating diabetic macular edema, in a human subject diagnosed with diabetic macular edema, comprising:
every four weeks intravitreally administering 2 mg aflibercept and 6 mg nesvacumab in a pharmaceutical composition comprising
(i) 40 mg/ml of aflibercept;
(ii) 120 mg/ml of nesvacumab;
(iii) a sodium phosphate buffer at pH of 6.2±0.3;
(iv) polysorbate 20;
(v) sodium chloride; and
(vi) sucrose,
to the subject.

Assignees

• Regeneron Pharma

Inventors

• Vitti Robert L
• Erickson Kristine A
• Chu Karen W
• Wiegand Stanley J
• Cao Jingtai
• Lobov Ivan B
• Wadhwa Saurabh
• Graham Kenneth S
• Dix Daniel

Classifications

• C07K16/46

  Hybrid immunoglobulins (hybrids of an immunoglobulin with a peptide not being an immunoglobulin C07K19/00) · CPC title

• C07K16/22

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

• C07K14/71

  for growth factors; for growth regulators · CPC title

• A61K2300/00

  Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00 · CPC title

• A61K2039/505

  comprising antibodies · CPC title