LumiThera Inc. has received de novo marketing authorization from the U.S. Food and Drug Administration (FDA) for its Valeda Light Delivery System, a photobiomodulation device indicated for the treatment of dry age-related macular degeneration (AMD). This marks a significant milestone as Valeda is the first FDA-authorized treatment for vision loss associated with dry AMD.
The FDA's decision was supported by data from the pivotal LIGHTSITE III trial, a multi-center, randomized, sham-controlled study. The trial evaluated the safety and efficacy of the Valeda Light Delivery System in patients with dry AMD. Results from LIGHTSITE III demonstrated that Valeda was effective in maintaining visual acuity over a 24-month period, meeting its primary endpoint. Furthermore, the device showed a statistically significant reduction in the conversion to geographic atrophy among patients with intermediate AMD.
"Valeda is the first and only FDA-authorized treatment for dry AMD," said Clark Tedford, PhD, President and CEO of LumiThera. "Valeda improves and maintains visual acuity out to 24 months with repeat treatments as demonstrated in the LIGHTSITE III clinical trial. It is the first treatment for patients that are earlier in the disease, predominantly intermediate patients, that have not progressed to late-stage geographic atrophy. Our trials have demonstrated that treating earlier in the disease can have significant benefits for patients."
The Valeda Light Delivery System is designed to improve best corrected visual acuity by five or more letters during a 24-month period. The treatment involves a series of light therapy sessions administered over several weeks. The device has already been approved in the European Union and select countries in Latin America.
Dry AMD is a progressive disease affecting millions worldwide, leading to gradual vision loss. Currently, there are limited treatment options available, primarily focused on managing symptoms and slowing disease progression. The approval of Valeda offers a new therapeutic avenue for patients with dry AMD, particularly those in the earlier stages of the disease.
"With FDA authorization, we can offer Valeda to U.S. retina specialists, and their patients will now have access to treatment," Tedford added. "This is an exciting advancement in dry AMD disease management for both doctors and patients."
