Luxa shares early data on stem cell therapy for dry AMD

Luxa Biotech announced clinical data from its phase 1/2a trial evaluating RPESC-RPE-4W, a proprietary retinal pigment epithelium cell therapy for patients with dry age-related macular degeneration (dry AMD).

Each patient received a 50,000-cell suspension of RPESC-RPE-4W implanted under the macula. Post-implant clinical outcomes were assessed over 12 months for the worse-seeing group 1 and over three months for the better-seeing group 2.

Findings from six patients in the first low-dose cohort of the ongoing first-in-human trial were presented at the 77th Annual Wills Eye Conference in Philadelphia, Pennsylvania. Best corrected visual acuity (BCVA) improvements were substantial, with group 1 experiencing an average gain of +21.67 ETDRS letters at 12 months and group 2 showing a +3.3-letter improvement at three months. No serious adverse events related to the investigational therapy were observed.

According to Luxa, 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. There are no approved vision-improving treatments for dry AMD, which causes diminished vision accompanied by loss of central retinal pigmented epithelium cells in individuals aged 55 and older.

Luxa, a joint venture of the South Korean tech company Y2 Solution and the Neural Stem Cell Institute in New York, received a $4 million grant from the California Institute for Regeneration Medicine to support the ongoing phase 1/2a study of RPESC-RPE-4W in May 2024.