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Luxa Biotechnology LLC announced results from its phase 1/2a clinical trial titled “Safety and Tolerability of RPE Stem Cell-derived RPE (RPESC-RPE) Transplantation in Patients with Dry Age-related Macular Degeneration: Low Dose Clinical Outcomes.”1 The results
Luxa is a clinical-stage biotechnology company developing novel adult retinal pigment epithelial stem cell (RPESC) therapies for dry
The main objective of the open-label phase 1/2a clinical trial (
It implants RPESC-RPE-4W cell suspensions in three dose cohorts: cohort 1 (50,000 cells), cohort 2 (150,000 cells), and cohort 3 (250,000 cells).3
Cohort 1, composed of 3 worse-seeing subjects with best-corrected visual acuity (BCVA) of 20/200–20/800, assessed by reading the standardized Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart, completed its low-dose interventions.3 Six subjects received a subretinal suspension of 50,000 RPESC-RPE-4W cells, and no significant inflammation, tumor, or product-related serious adverse events were observed or reported.1,3 Patients with better baseline vision showed more modest gains (+3.0 letters at 6 months).1
“The results from cohort 1 demonstrate the potential of RPESC-RPE-4W not only to restore vision in patients with severe vision loss but also to benefit those at earlier stages of diseases,” Keith Dionne, PhD, CEO of Luxa Biotechnology, said in a press release.
Best-corrected visual acuity (BCVA) in the 3 worse-seeing group A subjects improved by an average of +21.67 letters from baseline at 12 months, while 3 better-seeing group B subjects improved by an average of +3.0 letters at 6 months.3 The positive safety and tolerability outcomes for low-dose cohort 1 enabled dose escalation to mid-dose RPESC-RPE-4W therapy for dry AMD, the journal noted.3
“We are excited to continue advancing our clinical program, which recently received regenerative medicine advanced therapy (RMAT) designation from the FDA, as a potential new regenerative therapy for dry AMD, a leading cause of blindness with no currently approved vision-improving treatments,” Dionne said.1
Source: www.ophthalmologytimes.com
Author: | Date: 2025-09-22 18:48:00