Methods for treating neovascular age-related macular degeneration

Patent metadata

Field	Value
Publication number	US-10035850-B2
Application number	US-201514934731-A
Country	US
Kind code	B2
Filing date	Nov 6, 2015
Priority date	Nov 7, 2014
Publication date	Jul 31, 2018
Grant date	Jul 31, 2018

Abstract

A method is provided for reducing the treatment burden for patients who have an intraocular neovascular disorder, the method comprising administering a therapeutically effective amount of VEGF antagonist on a dosing schedule that includes treatment intervals of 8 and/or 12 weeks.

First claim

What is claimed is:

1. A method for treating neovascular age-related macular degeneration (nAMD) in a mammal, the method comprising:
a) administering to the mammal three individual doses of a VEGF antagonist at 4-week intervals, wherein the VEGF antagonist is an anti-VEGF antibody that comprises the sequence of SEQ ID NO: 3;
b) assessing the mammal for best corrected visual acuity (BCVA), visual acuity (VA), central subfield thickness (CSFT), and the presence of intraretinal cysts/fluid at week 12;
c) assessing the mammal for BCVA, VA, CSFT, and the presence of intraretinal cysts/fluid at week 16;
d) assessing the mammal for BCVA, VA, CSFT, and the presence of intraretinal cysts/fluid at week 20; and
e) administering to the mammal an additional dose of the VEGF antagonist at week 20 and once every 8 weeks (q8 regimen) thereafter if the following criteria are met and every 12 weeks (q12 regimen) thereafter if the following criteria are not met:
a) decrease in BCVA of ≥5 letters, due to nAMD disease activity, at Week 16 compared to Baseline,
b) decrease in BCVA of ≥5 letters, due to nAMD disease activity, at Week 16 compared to Week 12,
c) VA decline of ≥3 letters and CSFT increase ≥75 μm, at Week 16 compared to Week 12, and
d) new or worsening intraretinal cysts (IRC)/intraretinal fluid (IRF) at Week 16 compared to Week 12.

2. The method of claim 1 , further comprising assessing the mammal at Weeks 32 and 44 for BCVA, and administering to the mammals additional doses on a q8 regimen after the further assessment at Week 32 or 44 if BCVA is ≥5 letters due to nAMD disease activity compared to Week 12.

3. The method of claim 1 , wherein the mammal is a human.

4. The method of claim 1 , wherein the VEGF antagonist is administered by intravitreal injection.

5. A method for treating neovascular AMD (nAMD) comprising administering to a mammal three individual doses of a VEGF antagonist at 4-week intervals, followed by additional doses every 12 weeks (q12) and/or every 8 weeks (q8) depending on the outcome of disease activity assessments using pre-defined visual and anatomic criteria as assessed at Weeks 12, 16, 20, 32, and 44 after the first individual dose is administered, wherein the VEGF antagonist is an anti-VEGF antibody that comprises the sequence of SEQ ID NO: 3, wherein the mammal is treated every 8 weeks (q8 regimen) starting at Week 16 if the following criteria are met and every 12 weeks (q12 regimen) starting at Week 20 if the following criteria are not met:
a) decrease in BCVA of ≥5 letters, due to neovascular AMD (nAMD) disease activity, at Week 16 compared to Baseline,
b) decrease in BCVA of ≥5 letters, due to nAMD disease activity, at Week 16 compared to Week 12,
c) VA decline of ≥3 letters and CSFT increase ≥75 μm, at Week 16 compared to Week 12, and
d) new or worsening intraretinal cysts (IRC)/intraretinal fluid (IRF) at Week 16 compared to Week 12.

6. The method of claim 5 , further comprising assessing a mammal selected for q12 regimen at weeks 20, 32, and 44 for BCVA, and treating the mammals on a q8 regimen after the further assessment if BCVA is ≥5 letters due to nAMD disease activity compared to Week 12.

7. The method of claim 5 , wherein the mammal is a human.

8. The method of claim 5 , wherein the VEGF antagonist is administered by intravitreal injection.

9. The method of claim 5 , wherein additional disease activity assessments are made at Weeks 48, 56, 68, and 80.

10. The method of claim 5 , wherein the disease activity assessment comprises assessing BCVA, VA, central subfield thickness (CSFT), and/or presence of intraretinal cysts/fluid (IRC/IRF).

Assignees

• Novartis Ag
• Novartis Pharma Ag

Inventors

• Gekkieva Margarita
• Sallstig Peter
• Schmidt Werner
• Warburton James
• Weichselberger Andreas

Classifications

• A61P43/00

  Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 · CPC title

• A61P27/02

  Ophthalmic agents · CPC title

• A61K9/0048

  Eye, e.g. artificial tears · CPC title

• C07K2317/56

  variable (Fv) region, i.e. VH and/or VL · CPC title

• A61B3/12

  for looking at the eye fundus, e.g. ophthalmoscopes (A61B3/13 takes precedence) · CPC title