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
Luxa Biotechnology LLC (Luxa) today announced clinical data from its Phase 1/2a clinical trial evaluating RPESC-RPE-4W, a proprietary retinal pigment epithelium (RPE) cell therapy for patients with dry age-related macular degeneration (dry AMD). 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 (NCT04627428). 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 I and over 3 months for the better-seeing Group II. No serious adverse events (SAEs) related to the investigational therapy were observed.
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.
“We are thrilled with these promising clinical outcomes, which mark a significant step forward in our progress towards addressing a major unmet need in dry AMD,” said Dr. Keith Dionne, CEO of Luxa. “This achievement underscores our commitment to reversing vision loss for millions of adults affected by dry AMD and geographic atrophy. We look forward to advancing our Phase 1/2a trial and evaluating higher dose cohorts.”
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