IP Library Granted Patent US 12,624,098
Granted Patent B2
US 12,624,098 · App. 18/166,996 · Granted May 12, 2026

Treatment of age-related macular degeneration and diabetic macular edema by administration of a bispecific antibody to VEGF and ANG-2

Inventors: Aaron Osborne (South San Francisco, CA); Jayashree Sahni (Basel, CH); Robert James Weikert (Basel, CH)
Assignees: Hoffmann-La Roche Inc.; Genentech, Inc.
C07K16/22A61P27/02A61K2039/505A61K2039/545C07K2317/31C07K2317/565
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Quick Facts
Patent No.
US 12,624,098
App. No.
18/166,996
Granted
May 12, 2026
Kind
B2
Abstract

The current invention relates to the use of bispecific antibodies that bind to human vascular endothelial growth factor (VEGF) and to human angiopoietin-2 (ANG-2) for the treatment of ophthalmologic diseases, such as age-related macular degeneration and diabetic macular edema, where the bispecific antibodies are administered intravitreally every 8 weeks or less frequently.

Claims (29)

1 . A method of treating a patient suffering from an ocular vascular disease, the method comprising:

administering to the patient an effective amount of a bispecific antibody which binds to human vascular endothelial growth factor (VEGF) and to human angiopoietin-2 (ANG-2), and comprises the amino acid sequences of SEQ ID NO: 17, of SEQ ID NO: 18, of SEQ ID NO: 19, and of SEQ ID NO: 20,

wherein the bispecific antibody is administered intravitreally every 8 weeks or less frequently following a treatment initiation comprising 3 to 7 monthly administrations, in a dose of about 5 to 7 mg,

wherein the ocular vascular disease is Age-Related Macular Degeneration (AMD).

2 . The method according to claim 1 , wherein AMD is neovascular (wet) AMD (nAMD).

3 . The method according to claim 1 , wherein the bispecific antibody is administered every 10 to 12 weeks.

4 . The method according to claim 1 , wherein the bispecific antibody is administered every 11 to 13 weeks.

5 . The method according to claim 1 , wherein the bispecific antibody is administered every 12 to 14 weeks.

6 . The method according to claim 1 , wherein the bispecific antibody is administered every 13 to 15 weeks.

7 . The method according to claim 1 , wherein the bispecific antibody is administered every 14 to 16 weeks.

8 . The method according to claim 1 , wherein the bispecific antibody is administered in a dose of about 6 mg.

9 . The method according to claim 8 , wherein the bispecific antibody is administered at a concentration of about 120 mg/ml.

10 . The method according to claim 1 , wherein the patient has not been previously treated with an anti-VEGF treatment.

11 . The method according to claim 1 , wherein the patient has been previously treated with an anti-VEGF treatment.

12 . The method according to claim 1 , wherein the treatment initiation comprises 4 to 6 monthly administrations.

13 . The method according to claim 12 , wherein administration following the treatment initiation comprises a dosing schedule that extends the administration interval in stable absence of disease, or shortens the interval if there is disease activity.

14 . The method according to claim 13 wherein such dosing schedule includes that the patient receives Q8W or Q12W or Q16W dosing.

15 . The method according to claim 13 , wherein the stable absence of disease is determined as:

Central Subfield Thickness (CST) increased by <50 μm; and/or

Best Corrected Visual Acuity (BCVA/ETDRS) decreased by <5 letters

and the disease activity is determined as

Central Subfield Thickness (CST) increased by ≥50 μm; and/or

Best Corrected Visual Acuity (BCVA/ETDRS) decreased by ≥5 letters.

16 . The method according to claim 13 wherein such dosing schedule includes that the patient receives Q8W dosing.

17 . The method according to claim 13 wherein such dosing schedule includes that the patient receives Q12W dosing.

18 . The method according to claim 13 wherein such dosing schedule includes that the patient receives Q16W dosing.

19 . The method according to claim 1 , wherein the effective amount of the bispecific antibody prolongs the time to retreatment and/or prolongs the time to loss of visual acuity and, wherein the retreatment with the bispecific antibody is administered in presence of a disease activity which is determined as:

Central Subfield Thickness (CST) increase by ≥50 μm; and/or

Best Corrected Visual Acuity (BCVA/ETDRS) decrease by ≥5 letters.

Assignments (5)
CORRECTIVE ASSIGNMENT TO CORRECT THE CONVEYING PARTY DATA PREVIOUSLY RECORDED AT REEL: 064760 FRAME: 0019. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Sep 6, 2023
From: WEIKERT, ROBERT JAMES; SAHNI, JAYASHREE
To: F. HOFFMANN-LA ROCHE AG
Reel/Frame 064811/0804 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 31, 2023
From: WEICKERT, ROBERT JAMES; SAHNI, JAYASHREE
To: F. HOFFMANN-LA ROCHE AG
Reel/Frame 064760/0019 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 31, 2023
From: F. HOFFMANN-LA ROCHE AG
To: HOFFMANN-LA ROCHE INC.
Reel/Frame 064760/0036 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 31, 2023
From: F. HOFFMANN-LA ROCHE AG
To: HOFFMANN-LA ROCHE INC.
Reel/Frame 064760/0051 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 31, 2023
From: WEIKERT, ROBERT JAMES; SAHNI, JAYASHREE
To: F. HOFFMANN-LA ROCHE AG
Reel/Frame 064760/0033 →
Continuity (5)
Continuation 16985477 · Aug 5, 2020
Continuation PCTEP2019052704 · Feb 5, 2019
Provisional Application 62729333 · Sep 10, 2018
Provisional Application 62627103 · Feb 6, 2018
Related Publication 20230416353A1 · Dec 28, 2023
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