Let there be green light: The FDA has cleared its first light-based therapy for dry age-related macular degeneration—which the agency described as being capable of improving a patient’s vision equal to moving down about one line on a standard eye chart.
LumiThera’s Valeda system relies on photobiomodulation, or the use of different wavelengths of light to stimulate activity in the cells of the retina. By targeting the mitochondria, the company says it can trigger a cascade of increased metabolism and cellular proliferation.
Dry AMD is one of the two forms of the ocular disease that ranks as the leading cause of blindness in adults over age 65, driven by the slow loss of photoreceptor cells over time. Dry AMD begins with protein deposits in the macula, or the center of the retina, which result in cloudy or blocked sight in the center of the vision field. About 10% of people progress to what is described as wet AMD, where abnormal blood vessels begin to grow in the back of the eye.
“Today’s action brings to market the first therapeutic option for adult patients with dry AMD,” Malvina Eydelman, director of the FDA’s Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, said in a statement. “This authorization reinforces FDA’s commitment to assuring access to innovative, safe and effective medical devices to treat high-prevalence, degenerative conditions.”
The agency estimated that about 20 million people in the U.S. were living with either dry or wet AMD in 2019. Meanwhile, the company projects global prevalence to increase by 20% to about 240 million people by 2030.
According to LumiThera, the de novo-cleared Valeda demonstrated improvements in measures of best-corrected visual acuity following two years of treatment in a randomized, controlled clinical trial. The system was previously approved in Europe with a CE Mark.
“We have been working hard to bring Valeda, a multiwavelength photobiomodulation device to our U.S. patients for several years,” said LumiThera President and CEO Clark Tedford. “We now have a non-invasive treatment option for dry AMD patients that may improve vision and address the disease earlier before permanent vision loss.”