Methods for treating ocular diseases

Patent metadata

Field	Value
Publication number	US-2016130337-A1
Application number	US-201514934731-A
Country	US
Kind code	A1
Filing date	Nov 6, 2015
Priority date	Nov 7, 2014
Publication date	May 12, 2016
Grant date	—

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; 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; and d) administering to the mammal an additional dose of the VEGF antagonist once every 8 weeks (q8 regimen) if the following criteria are met and every 12 weeks (q12 regimen) 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 a mammal selected for q12 regimen at Weeks 20, 32, and 44 for BCVA, and administering to the mammals selected for q8 regimen after the further assessment if BCVA is ≧5 letters due to nAMD disease activity compared to Week 12.

3 . The method of claim 1 , further comprising assessing a mammal selected for q8 regimen at Weeks 20, 32, and 48 for BCVA and the presence of intraretinal cysts/fluid (IRC/IRF), and administering to the mammals additional doses of the VEGF antagonist every 12 weeks after the Week 48 assessment if there is not a decrease in BCVA of ≧5 letters due to nAMD disease activity at Week 48 compared to Week 32, and there are no new or worsening IRC/IRF at Week 48 compared to Week 32.

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

5 . The method of claim 1 , wherein the VEGF antagonist is an anti-VEGF antibody.

6 . The method of claim 5 , wherein the anti-VEGF antibody comprises the sequence of SEQ ID NO: 3.

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

8 . 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.

9 . The method of claim 8 , wherein additional assessments are made at Weeks 48, 56, 68, and 80.

10 . The method of claim 8 , wherein the disease activity assessment comprises assessing BCVA, VA, central subfield thickness (CSFT), and/or presence of intraretinal cysts/fluid (IRC/IRF).

11 . The method of claim 10 , wherein the mammal is treated every 8 weeks (q8) if the following criteria are met and every 12 weeks (q12) 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 1, 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.

12 . The method of claim 11 , further comprising assessing a mammal selected for q12 regimen at weeks 20, 32, and 44 for BCVA, and administering to the mammals selected for q8 regimen after the further assessment if BCVA is ≧5 letters due to nAMD disease activity compared to Week 12.

13 . The method of claim 11 , further comprising assessing a mammal selected for q8 regimen at Weeks 20, 32, and 48 for BCVA and the presence of intraretinal cysts/fluid (IRC/IRF), and administering to the mammals additional doses of the VEGF antagonist every 12 weeks after the Week 48 assessment if there is not a decrease in BCVA of ≧5 letters due to nAMD disease activity at Week 48 compared to Week 32, and there are no new or worsening IRC/IRF at Week 48 compared to Week 32.

14 . The method of claim 8 , wherein the mammal is a human.

15 . The method of claim 8 , wherein the VEGF antagonist is an anti-VEGF antibody.

16 . The method of claim 15 , wherein the anti-VEGF antibody comprises the sequence of SEQ ID NO: 3.

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

Assignees

• Novartis 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

• C07K2317/567

  Framework region [FR] · CPC title

• A61K9/0048

  Eye, e.g. artificial tears · CPC title

• C07K2317/56

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