Jan. 7, 2025 – A new light therapy device could be a game-changer for millions at risk of vision loss. The FDA has approved a first-of-its-kind treatment for dry age-related macular degeneration, a leading cause of blindness in adults over 55.Developed by LumiThera Inc., the device showed promising results in a clinical trial, marking it as the first effective therapy for AMD. Approved under the FDA’s “De Novo” process, the treatment offers hope where no similar options existed.
The LumiThera study, done at 10 retinal centers in the United States, assessed the safety and effectiveness of the system on the eyes of 100 people over a 24-month period. The data collected during the trial was then analyzed over a 13-month period.
The trial found that LumiThera’s Valeda Light Delivery System significantly reduced the risk of vision loss and the start of geographic atrophy in dry AMD. More than 58% of the people studied reported improvements in their sight after the therapy.
Geographic atrophy is a treacherous hallmark of late-stage dry AMD, in which cells in the center of the eye’s retina – called the macula – die, which can cause severe vision loss in advanced forms of the disease.LumiThera’s system is the first treatment authorized by the FDA for vision loss from dry AMD. AMD is a leading cause of irreversible blindness or vision loss in people over 60. Around 20 million people in the United States have AMD, with dry AMD accounting for 90% of diagnosed cases. It’s considered “dry” because it doesn’t involve the growth of abnormal blood vessels, the way the “wet” form of AMD does.The percentage of people with dry AMD who lose their vision depends on how severe the disease is and whether it becomes the wet form, which is more severe than the dry form. The wet form is marked by blood vessels leaking into the macula and the loss of central vision. Around 10%-15% of dry AMD cases become the wet form.During a presentation this year at a meeting of the American Society of Retina Specialists, Eleonora Lad, MD, PhD, vice chair of ophthalmology clinical research at Duke University Medical Center, said the treatment – known as “photobiomodulation” (PBM) – is the first to deliver “meaningful effects” in dry AMD.
“This … treatment will have a huge impact on the standard of care of patients with dry AMD because it will allow retina specialists and practitioners to intervene at earlier stages before photoreceptor loss is irreversible, before the late-stage disease,” she said.Lad was one of many doctors and researchers who headed the clinical trial.
