RPESC-RPE-4W / Luxa Biotechnology - LARVOL DELTA

Safety and tolerability of RPESC-RPE transplantation in patients with dry age-related macular degeneration: Low-dose clinical outcomes. (PubMed, Cell Stem Cell) - P1/2 | "Three better-seeing group B subjects improved by an average of +3.0 letters at 6 months. The positive safety and tolerability outcomes for low-dose cohort 1 enabled dose escalation to mid-dose RPESC-RPE-4W therapy for dry AMD."

Clinical data • Journal • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Oncology • Ophthalmology • Retinal Disorders • Transplantation

Luxa to Present Phase 1/2a Clinical and Preclinical Data on RPESC-RPE-4W Therapy for Dry AMD at 2025 ARVO Annual Meeting (Businesswire) - "Luxa Biotechnology LLC...announced the company will present Phase 1/2a clinical and preclinical data on the company’s adult retinal pigment epithelial stem cell (RPESC) therapy for dry age-related macular degeneration (AMD) at the 2025 ARVO Annual Meeting taking place May 4-8, 2025 in Salt Lake City, Utah."

P1/2 data • Preclinical • Dry Age-related Macular Degeneration

Safety and Tolerability of RPE Stem Cell-derived RPE (RPESC-RPE) Implantation in Patients with Dry Age-related Macular Degeneration (AMD): Early Low Dose Clinical Outcomes (ARVO 2025) - P1/2 | "Methods Our approach to RPE replacement implants adult RPE stem cell-derived RPE (RPESC-RPE) that are at an intermediate 4-week progenitor stage of differentiation (RPESC-RPE-4W)...Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Clinical • Clinical data • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Preclinical safety and efficacy of an adult progenitor cell product, RPESC-RPE-4W, as therapy for dry Age-Related Macular Degeneration (ARVO 2025) - P1/2 | "Our novel approach uses adult RPE stem cells (RPESC) to manufacture new RPE cells for cell replacement therapy. This study describes the preclinical safety, efficacy and manufacturing data that led to our Investigational New Drug allowance and first-in-human clinical trial (NCT04627428)."

Preclinical • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Safety and Tolerability of RPE Stem Cell-derived RPE(RPESC-RPE) Transplantation in Patients with Dry Age-related Macular Degeneration (AMD) (clinicaltrials.gov) - P1/2 | N=18 | Recruiting | Sponsor: Luxa Biotechnology, LLC | Trial completion date: May 2025 ➔ Dec 2026 | Trial primary completion date: May 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Transplantation

Luxa Biotechnology Presents Clinical Data from First-in-Human Retinal Pigment Epithelium Cell Therapy Trial for Dry Age-Related Macular Degeneration at the 77th Annual Wills Eye Conference (Businesswire) - P1/2a | N=18 | NCT04627428 | Sponsor: Luxa Biotechnology, LLC | "The data were presented today at the 77th Annual Wills Eye Conference in Philadelphia, Pennsylvania. Findings from six patients in the first low-dose cohort of the ongoing first-in-human trial were presented....Best Corrected Visual Acuity (BCVA) improvements were substantial, with Group I experiencing an average gain of +21.67 ETDRS letters at 12 months and Group II showing a +3.3-letter improvement at 3 months. These gains are particularly meaningful given that even a 5- to 10-letter improvement can translate into a real-world functional benefit for patients, such as improved reading ability, better recognition of faces, and enhanced mobility."

P1/2 data • Dry Age-related Macular Degeneration

Luxa Biotechnology Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to RPESC-RPE-4W Transplantation for the Treatment of Dry Age-Related Macular Degeneration (Businesswire) - "Luxa Biotechnology LLC...announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RPESC-RPE-4W transplantation for the treatment of patients with dry age-related macular degeneration (dry AMD)....Dr. Jeffery Stern, Luxa’s Chief Medical Officer, will present safety, tolerability, and early efficacy data of RPESC-RPE-4W transplantation in the first cohort (N=6) of dry AMD patients at the 77th annual Wills Eye Conference in Philadelphia on March 6, 2025."

FDA event • P1/2 data • Dry Age-related Macular Degeneration