Posted on 2023-02-17 in Newsletter

FDA Approves Apellis’ SYFOVRE™ (pegcetacoplan injection) for Geographic Atrophy (GA)

FDA Approves Apellis' SYFOVRE™ (pegcetacoplan injection) for Geographic Atrophy (GA)

FDA Approves Apellis' SYFOVRE™ (pegcetacoplan injection) for Geographic Atrophy (GA)

Apellis Pharmaceuticals, Inc. announced today that SYFOVRE™ (pegcetacoplan injection) has been approved by the United States Food and Drug Administration (FDA) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). SYFOVRE™ (pegcetacoplan injection) is the first and only FDA-approved treatment for GA. GA is a leading cause of blindness, affecting over one million people in the U.S. and five million worldwide.

Publish Date: 17-02-2023   Source: Apellis Pharmaceuticals, Inc.

Geographic atrophy (GA) is defined as the late stage of the dry form of age-related macular degeneration (AMD). Some patients with age-related macular degeneration (AMD) may develop geographic atrophy (GA), which refers to regions of the retina where cells waste away and die (atrophy). The edge of GA was recognized as the termination of continuous RPE. Internal to the edge, there was an absence of RPE cells over wide areas, although a few RPE cells were scattered over the area of GA. The first visible alterations of AMD are drusen and retinal pigment epithelial (RPE) irregularities. This early stage of age-related maculopathy (ARM) may progress to either geographic atrophy (GA) or exudative AMD. Approximately 11% of patients with atrophic AMD eventually progress to the exudative form at four years of evolution. In some eyes with choroidal neovascularisation (CNV) also leads to GA.

  • In the USA, the prevalence of GA is 3.5% in subjects older than 65 years, accounting for approximately half the prevalence of exudative AMD.

However, the current Geographic atrophy (GA) treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (Pegcetacoplan, Avacincaptad pegol (Zimura®), ACU-4429, 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 Geographic atrophy (GA) treatment. The key companies in the advanced development stage are Apellis Pharmaceuticals, Inc., IVERIC bio, Inc., Kubota Vision Inc., etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Geographic atrophy (GA) 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.

About Thelansis:

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