4D Molecular Therapeutics Receives FDA Clearance for IND Application of 4D-150 for Diabetic Macular Edema Treatment

4D Molecular Therapeutics, a clinical-stage biotherapeutics company using directed evolution to create targeted genetic medicines, announced that the Food and Drug Administration (FDA) has approved their Investigational New Drug Application (IND) for 4D-150. 4D-150 is an R100 vector-based intravitreal genetic medicine for the treatment of Diabetic Macular Edema (DME) patients. The Phase 2 SPECTRA Clinical Trial aims to evaluate the efficacy of 4D-150 in individuals suffering from DME, as per the company statement.

Publish Date: 02-02-2023 Source: 4D Molecular Therapeutics

In Diabetic Macular Edema (DME), chronic hyperglycemia causes an up-regulation of vascular endothelial growth factor (VEGF), thus increasing vascular permeability and increased angiogenesis. While the underlying pathophysiology of DME is VEGF mediated, there is a growing body of evidence suggesting that inflammatory mediators are also partly responsible and that those mediators contribute substantially to the vascular permeability and edema present in DME. The most common cause of vision loss from DR is DME, which can occur at any stage of DR and is characterized by edema and retinal thickening the latter of which may also include hard exudates. As the earliest stages of DME are usually asymptomatic, individuals with DM are often unaware they have developed such complications. Symptoms are somewhat dependent on the location of the edema within the retina; non–center-involved macular edema is rarely symptomatic. Once the edema spreads to encompass the central macula, however, patients generally experience progressive vision loss that occurs anywhere from weeks to months after the initial symptom.

The global prevalence of Diabetic Macular Edema (DME) varies from 4.6% to 7.8% among diagnosed diabetic retinopathy patients.

However, the current Diabetic Macular Edema (DME) treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (MYL-1701P, CU06-1004, KSI-301, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Diabetic Macular Edema treatment. The key companies in the advanced development stage are Mylan Pharmaceuticals Inc, Curacle Co., Ltd., Kodiak Sciences Inc, etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Diabetic Macular Edema (DME) to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2021 to 2032.

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