January 7, 2025 -- The FDA has approved a groundbreaking light therapy device aimed at treating dry age-related macular degeneration (AMD), a leading cause of blindness in individuals over 55. Developed by LumiThera, Inc., this innovative treatment marks a significant advancement in the management of this condition.
The LumiThera device, known as the Valeda Light Delivery System, demonstrated promising outcomes in a clinical trial conducted at ten retinal centers across the United States. The study involved 100 participants over a 24-month period, with data analyzed over 13 months. Results indicated that over 58% of participants experienced improvements in vision following treatment.
Dry AMD, which constitutes 90% of diagnosed AMD cases, is characterized by the gradual deterioration of retinal cells in the macula, potentially leading to severe vision loss. The new light therapy is the first FDA-approved treatment specifically targeting vision loss associated with dry AMD.
During a recent presentation at the American Society of Retina Specialists meeting, Dr. Eleonora Lad emphasized the treatment's potential to significantly alter the standard of care for dry AMD patients by allowing for earlier intervention before irreversible photoreceptor loss occurs.
Photobiomodulation (PBM), the mechanism behind this therapy, involves delivering specific wavelengths of light to the retina. This process enhances mitochondrial energy production, reduces inflammation, and increases nutrient supply to retinal cells, thereby improving cell survival rates in dry AMD.
While traditional treatments have included nutritional supplements and recently approved eye injections, PBM offers a non-invasive alternative. However, experts caution that further extensive trials are necessary to validate the therapy's efficacy and ensure its safety before broader FDA approval is pursued.