Luxa Biotechnology Reports Significant Results in Dry Age-Related Macular Degeneration Stem Cell Trial
Luxa Biotechnology LLC has shared clinical data from its Phase 1/2a trial of RPESC-RPE-4W, a retinal pigment epithelium cell therapy for dry age-related macular degeneration (dry AMD). On the trial page, they mention that “RPESC-RPE-4W is Allogeneic RPE stem cell (RPESC)-derived RPE cells (RPESC-RPE) isolated from the RPE layer of human cadaveric eyes are transplanted […]
Luxa Biotechnology LLC has shared clinical data from its Phase 1/2a trial of RPESC-RPE-4W, a retinal pigment epithelium cell therapy for dry age-related macular degeneration (dry AMD).
On the trial page, they mention that “RPESC-RPE-4W is Allogeneic RPE stem cell (RPESC)-derived RPE cells (RPESC-RPE) isolated from the RPE layer of human cadaveric eyes are transplanted under the macular.” The stem cells are sourced from adult retinal pigment epithelial stem cells and implanted into the affected patient’s eyes.
The company was granted an RMAT designation for the therapy in February of this year.
The trial will recruit up to 18 patients, and they’ve shared the results from six of them in the first low-dose cohort of their ongoing first-in-human trial (NCT04627428).
Each participant received a 50,000-cell suspension of RPESC-RPE-4W implanted under the macula. Clinical outcomes were monitored over 12 months for the worse-seeing Group I and over 3 months for the better-seeing Group II. The company reports that no serious adverse events related to the investigational therapy were observed.
The company also reports that Best Corrected Visual Acuity (BCVA) improvements were notable, 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. The company notes that the improvements are significant, as even a 5- to 10-letter gain can lead to real-world benefits for patients, including enhanced reading ability, better facial recognition, and improved mobility.
