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Treatment of ophthalmologic diseases

a technology for ophthalmologic diseases and ophthalmologic diseases, applied in the field of treatment of ophthalmologic diseases, can solve the problems of retinal swelling and impairing visual function, retinal dysfunction and loss of cision, and visual loss in industrialized nations

Inactive Publication Date: 2021-05-13
F HOFFMANN LA ROCHE INC +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The text is describing the results of a study using a certain treatment for a certain condition. The study found that the treatment was effective in improving vision in some patients. The technical effect of the treatment is to improve vision in patients with a certain condition.

Problems solved by technology

Bleeding and leakage from these vessels can cause retinal dysfunction and loss of cision Other retinal vascular disease, such as diabetic macular edema (DME) and macular edema secondary to retinal vein occlusion (RVO) are due to abnormal retinal leakage leading to retinal swelling and impairing visual function.
These conditions are leading causes of visual loss in industrialized nations.
Since the retina consists of well-defined layers of neuronal, glial, and vascular elements, relatively small disturbances such as those seen in vascular proliferation or edema can lead to significant loss of visual function.
Ischemic retinopathies are characterized by loss or dysfunction of the retinal vasculature which results in a reduction of blood flow and hypoxia.
The retina responds to hypoxia by generating signals to grow new blood vessels, but these new vessels are usually fragile and disorganized.
It is the growth of these abnormal new vessels that creates most of the threat to vision since they can leak, hemorrhage or lead to scarring that may end in retinal detachment.
Current treatments for ischemic retinopathies seek to halt the growth of the pathological vessels but do not address the underlying ischemia that drives their growth.
In the short term, anti-VEGF therapy can improve vision, but it does not address the underlying ischemia and in fact may exacerbate this condition as it inhibits all vessel growth, including beneficial collaterals.
There is also the serious concern of systemic exposure of these drugs in elderly and / or diabetic patients where new vessel growth may be required in ischemic brains, hearts or limbs.

Method used

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  • Treatment of ophthalmologic diseases
  • Treatment of ophthalmologic diseases
  • Treatment of ophthalmologic diseases

Examples

Experimental program
Comparison scheme
Effect test

example 1a

nd Durability of Treatment of Patients Suffering from Diabetic Macular Edema (DME)

Objectives

Primary Objective

[0345]The primary objective of this study were:

[0346]To evaluate the efficacy of the bispecific antibody that binds to human VEGF and human ANG2 comprising 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 (this antibody VEGFang2-0016 and its production is also described in detail in WO2014 / 009465 which is incorporated by reference) compared with an active comparator in treatment naïve patients with center-involving diabetic macular edema (CI-DME). Designations of this bispecific anti-VEGF / ANG2 antibody herein are RO6867461 or RG7716 or VEGFang2-0016, or faricimab. Vials of sterile, colorless to brownish, preservative-free solution of RO6867461 for IVT administration of either 1.5 mg or 6 mg dose every 4 weeks were used. The concentration of the bispecific antibody was about 120 mg / ml.

Secondary Objectives

[0347]The secondary ob...

example 1b

nd Durability of Treatment of Patients Suffering from Diabetic Macular Edema (DME)

[0444]In a further study analogous to the above described study under Example 1A, patients suffering from DME (e.g center-involving diabetic macular edema (CI-DME)). are treated with the bispecific antibody that binds to human VEGF and human ANG2 comprising 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. As active comparator in treatment e.g. aflibercept and / or ranibizumab and / or brolicuzimab will be used. Patients include anti-VEGF treatment-naïve patients (have not been previously treated with anti-VEGF monotherapy with e.g. e.g. aflibercept and / or ranibizumab and / or brolicuzimab)) and also a group of patients which have been previously treated with anti-VEGF monotherapy. Designations of the respective bispecific antibody that binds to human VEGF and human ANG2 are RO6867461 or RG7716. Vials of sterile, colorless to brownish, preservative-free solu...

example 2a

nd Durability of Treatment of Patients Suffering from Age-Related Macular Degeneration (AMD)

Objectives and Endpoints

[0456]This study has evaluated the efficacy, safety, and pharmacokinetics of RO6867461 administered at 12- and 16-week intervals in patients with neovascular age-related macular degeneration (nAMD). RO6867461 is a bispecific antibody that binds to human VEGF and human ANG2 comprising 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 (this antibody VEGFang2-0016 and its production is also described in detail in WO2014 / 009465 which is incorporated by reference). Designations of this bispecific anti-VEGF / ANG2 antibody herein are RO6867461 or RG7716 or VEGFang2-0016 or faricimab.

[0457]Specific objectives and corresponding endpoints for the study are outlined below.

Objectives and Corresponding Endpoints

Primary Efficacy Objective

[0458]To evaluate the efficacy of RO6867461 on visual acuity when administered at 12- and 16-week ...

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Abstract

The current invention relates to the use of antibodies which bind to VEGF and ANG2 for the treatment of ophthalmologic diseases.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of International Application No. PCT / EP2019 / 052704, filed Feb. 5, 2019, claiming priority to provisional Application No. 62 / 627,103 filed Feb. 6, 2018 and provisional Application No. 62 / 729,333, filed Sep. 10, 2018, which are incorporated herein by reference in their entireties.SEQUENCE LISTING[0002]This application contains a Sequence Listing which has been submitted electronically in ASCII format and is hereby incorporated by reference in its entirety. Said ASCII copy, created on Jul. 15, 2020, is named Sequence_Listing.txt and is 44,608 bytes in size.[0003]The current invention relates to the use of antibodies which bind to VEGF and ANG2 for the treatment of ophthalmologic diseases.BACKGROUND OF THE INVENTION[0004]Angiogenesis is implicated in the pathogenesis of a variety of disorders which include solid tumors, intraocular neovascular syndromes such as proliferative retinopathies or age-related macu...

Claims

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Application Information

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IPC IPC(8): C07K16/22A61P27/02
CPCC07K16/22A61K2039/505A61P27/02A61K39/3955C07K2317/31C07K2317/35C07K2317/71A61K39/00A61K2039/545C07K2317/565
Inventor OSBORNE, AARONSAHNI, JAYASHREEWEIKERT, ROBERT JAMES
Owner F HOFFMANN LA ROCHE INC