FDA gives green light for AMD treatment trials


The US Food and Drug Administration (FDA) has granted clearance for Endogena’s Investigational New Drug (IND) application for EA 2351, a potential treatment for geographic atrophy (GA).

GA is an advanced form of age-related macular degeneration (AMD). The first-in-human study is set to commence in 2024.

The company is currently investigating another candidate, EA 2353, for retinitis pigmentosa.

EA-2351 and EA-2353 target specific cell populations through different pathways, hinging on their unique chemical structures. While EA-2353 focuses on activating one set of cells in the context of retinitis pigmentosa, EA-2351 centres on retinal pigment epithelial (RPE) cells.

Matthias Steger, CEO of Endogena Therapeutics, said: “Our team is thrilled to have reached yet another significant milestone, and my thanks go to everyone involved. We look forward to continuing to develop yet another potential therapy for a condition with a high unmet medical need, thereby providing hope for patients affected by AMD.”

AMD is a leading cause of irreversible vision loss in the developed world, and it has been estimated that almost 9% of the population older than 45 years of age are affected.

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