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Personalized treatment of ophthalmic diseases

A disease-based, diabetic technology for the personalized treatment of ophthalmic diseases that addresses instability, incomplete resolution, and heavy burden on patients and healthcare providers

Pending Publication Date: 2022-04-12
F HOFFMANN LA ROCHE & CO AG +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, to achieve optimal outcomes in the absence of validated predictive biomarkers for treatment frequency, the standard anti-VEGF approach in DME still relies on frequent surveillance visits, presenting patients and healthcare providers with heavy burden
Furthermore, anti-VEGF monotherapy does not fully address other pathways that contribute to the exacerbation of diabetic eye disease, including inflammation and pericyte instability

Method used

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  • Personalized treatment of ophthalmic diseases
  • Personalized treatment of ophthalmic diseases
  • Personalized treatment of ophthalmic diseases

Examples

Experimental program
Comparison scheme
Effect test

example

[0663] Treatment of patients with vascular eye diseases using bispecific antibodies that bind to human VEGF and to human ANG2

example 1

[0665] Efficacy and durability of treatment in patients with neovascular age-related macular degeneration (nAMD) using individualized treatment intervals

[0666] In an earlier 52-week phase II investigative study, it was seen, inter alia, that in all patients involved, RO6867461 (farciximab) was effective every 12 weeks in treatment-naïve nAMD patients. The efficacy of weekly and 16 week administration was longer lasting (longer time required for retreatment). Three arms were studied - arm A (Q12W): 6 mg RO6867461 intravitreal (IVT) every 4 weeks to week 12 (4 injections), then 6 mg RO6867461 IVT every 12 weeks to week 48 (at weeks 24, 36 and 48 Injection; 3 injections) ……………………………—Arm B (Q16W): 6 mg RO6867461 IVT every 4 weeks to Week 12 (4 injections), then 6 mg RO6867461 IVT every 16 weeks to Week 48 Weeks (injections at Weeks 28 and 44; 2 injections)……………………………………………—Group C (comparison group): 0.5 mg ranibizumab IVT every 4 weeks to At week 48 (13 injections), only...

example 2

[0745] Efficacy and durability of bispecific anti-VEGF / ANG2 therapy in patients with diabetic macular edema (DME) using individualized treatment intervals

[0746] In an earlier phase II study of 36 weeks in patients with diabetic macular edema (DME), some degree of potential longer persistence (possibly longer retreatment time) was seen in all relevant patients ). The three study groups were treated as follows: Group A: 0.3 mg ranibizumab, intravitreal (IVT); Group B: 1.5 mg RO6867461 (Fariximab), IVT; monoclonal antibody), IVT.

[0747] Results regarding potential longer retreatment times for RO6867461 (fariximab, VA2) Figure 6 shown in . Figure 6 Time to retreatment in DME patients after cessation of dosing (after 20 weeks or 6 monthly doses = time after last intravitreal (IVT) administration) is shown, based on disease activity as assessed by: BCVA reduction ≥5 letters, and a CST increase of ≥50 μm (=patients with an event). Bispecific anti-VEGF / ANG2 antibody...

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Abstract

The present invention relates to antibodies that bind to VEGF and ANG2 for use in the treatment of ocular vascular diseases, such as neovascular AMD (nAMD) (also referred to as choroidal angiogenesis [CNV] secondary to age-related macular degeneration [AMD] or wet AMD), diabetic retinopathy, in particular diabetic macular edema (DME) or macular edema secondary to retinal vein occlusion (RVO).

Description

technical field [0001] The present invention relates to antibodies that bind to VEGF and ANG2 for use in the treatment of ocular vascular diseases such as neovascular AMD (nAMD) (also known as choroidal vasculature secondary to age-related macular degeneration [AMD] or wet AMD) neonatal [CNV]), diabetic retinopathy especially diabetic macular edema (DME) or macular edema secondary to retinal vein occlusion (RVO). Background technique [0002] Ocular vascular disorders such as neovascular AMD (nAMD) (also called choroidal neovascularization [CNV] secondary to age-related macular degeneration [AMD] or wet AMD), diabetic retinopathy, especially diabetic macular edema (DME ) is a serious disease that often results in vision loss and blindness. [0003] Neovascular age-related macular degeneration (nAMD) (also known as choroidal neovascularization [CNV] secondary to age-related macular degeneration [AMD] or wet AMD) is an advanced form of AMD that can cause acute and severe visi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K16/22A61K39/395A61P27/02G16H20/10G16H50/20
CPCC07K16/22A61K2039/505A61P27/02C07K2317/31A61K2039/545C07K2317/76G16H20/10G16H50/20C07K16/468
Inventor 休·林亚伦·奥斯本大卫·安德鲁·西尔弗曼罗伯特·詹姆斯·威克特杰弗里·R·威利斯
Owner F HOFFMANN LA ROCHE & CO AG
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