US FDA has granted approval to Roche’s Vabsymo (Faricimab) for the treatment of wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). Vabsymo is a novel humanized bispecific antibody that works by inhibiting the angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) pathways. Blocking both pathways is expected to stabilize blood vessels and potentially improve vision outcomes in patients with retinal conditions. The rapid approval of the drug is based on the promising results of the Phase-III clinical trial that demonstrated Vabysmo given at intervals of up to four months achieved non-inferior vision gains versus aflibercept given every two months in the first year.
The global prevalence of DR and DME, for the period 2015 to 2019 was 27.0% for any DR comprising of 25.2%, NPDR, 1.4% PDR, and 4.6% DME. The lowest prevalence was in Europe at 20.6% and South East Asia at 12.5% and highest in Africa at 33.8%, Middle East and North Africa at 33.8%, and the Western Pacific region at 36.2%.
Comprehensive insight on patient segmentation based on, age, sex, Severity (Mild, moderate & Sever), Chronic, non-chronic, risk factors, identified biomarkers, symptoms, Clinical Manifestations has been provided into the epidemiology (Incidence and Prevalence) section of the Diabetic Macular Edema (DME) and its treatment in the 8 MM countries, covering the United States, EU5 (Germany, Spain, France, Italy, UK), Japan, and China
Apart from the approved therapies, there is a strong pipeline with different phases of development (I, II, and III) Beovu; Novartis, ONS-5010; Outlook Therapeutics, AR-1105; Aerie Pharmaceuticals, EYSU-VIS; Kala Pharmaceuticals; GB-102; GrayBug, Inc., Inveltys; Kala Pharmaceuticals, Inc., ProDex; Taiwan Liposome Company, Ltd., KSI-301; Kodiak Sciences Inc., LKA-651; Novartis AG. Companies like Roche Holding AG; Avastin, NeuBase Therapeutics, Inc.; NeuBase Therapeutics, Inc., Chengdu Kanghong Biotech Co., Ltd.; Conbercept, Gene Signal International SA; GS-101, Oxuri-on NV; Jetrea, Amarantus BioScience Holdings, Inc.; MANF building their assets in the early phase of development. Anti-VEGF agents inhibit only VEGF, which is a small component of DME. Inflammation has a strong role in diabetes, and the severity of diabetic retinopathy is directly related to the number of cytokines in the eye. Inflammatory cytokines are expressed at a higher level in eyes with DME, and eyes with more severe DME have an increased amount of cytokines, indicating a direct correlation with severity.
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