LUXA BIOTECHNOLOGY LLC
🇺🇸United States
FDA Grants RMAT Designation to Novel Cell Therapy for Dry AMD Treatment
• Luxa Biotechnology's RPESC-RPE-4W cell therapy receives FDA's Regenerative Medicine Advanced Therapy designation for treating dry age-related macular degeneration, based on promising Phase 1 data.
• The innovative treatment utilizes adult retinal pigment epithelial stem cells to generate replacement RPE cells, addressing progressive vision loss in AMD patients.
• Initial safety and efficacy data from the first cohort of six patients will be presented at the 77th annual Wills Eye Conference in Philadelphia in March 2025.
Phase 3 Trial Shows Promising Results for Novel Encapsulated Cell Therapy in MacTel Treatment
• Phase 3 clinical trials of NT-501, an encapsulated cell therapy delivering CNTF, demonstrated significant reduction in disease progression for macular telangiectasia type 2 patients, with up to 52% reduction in ellipsoid zone loss.
• The innovative implantable device, developed by Neurotech, maintains long-term viability with CNTF production documented for up to 14.5 years, offering a potential alternative to frequent intravitreal injections.
• FDA review of the therapy is currently underway with a PDUFA date set for March 18, 2025, marking a potential breakthrough in MacTel treatment.
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