FDA clears investigational new drug application for novel GA treatment
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Key takeaways:
- The FDA cleared an investigational new drug application for EA-2351 in geographic atrophy.
- Endogena plans to begin the first-in-human clinical investigation of EA-2351 in 2024.
The FDA granted clearance to an investigational new drug application for EA-2351, a novel compound for the treatment of geographic atrophy, according to a press release from Endogena Therapeutics.
EA-2351 is designed to regenerate and restore photoreceptor function by activating retinal pigment epithelial cells. The clearance will allow for the first-in-human clinical investigation of EA-2351, which Endogena plans to begin in 2024.
The FDA previously granted fast track designation for EA-2353 in retinitis pigmentosa, with a clinical trial beginning in July 2022.
“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,” Matthias Steger, PhD, MBA, CEO of Endogena Therapeutics, said in the release.
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