Poulsbo-based Lumithera celebrates a significant milestone as its innovative treatment for age-related macular degeneration (AMD) gains FDA approval, paving the way for enhanced care for patients across the U.S.
Clark Tedford, CEO of Lumithera, can’t stop smiling—and for good reason. The family-owned medical device company recently received FDA approval for Valeda, a groundbreaking light-based treatment for degenerative eye diseases, including AMD.
“This is the largest cause of vision loss in adults over 65,” said Tedford, who holds a doctorate in pharmacology. “Options for these patients are limited. Over time, the disease slowly erodes their vision, which can be devastating.”
Valeda uses light therapy to stimulate retinal tissue, enhancing blood flow and energy production in the eye. According to Tedford, the treatment has undergone rigorous testing, with five clinical trials supporting its development. The most recent pivotal trial led to the FDA’s approval in early November.
A Proven Technology Reaching New Frontiers
Valeda is not new to the global market. It has been available in Europe for four years and has received approval in Latin America. Now, with the FDA’s green light, patients in the U.S. will have access to this non-invasive therapy.
“Light therapy has a long history of safety and effectiveness,” Tedford explained, noting its success in treating conditions ranging from newborn jaundice to diabetic wounds.
For age-related macular degeneration, Valeda is specifically designed to address the dry form of the disease. This condition occurs when the macula, a part of the retina critical for central vision, deteriorates over time. By targeting the disease in its earlier stages, Valeda aims to slow vision loss, reduce inflammation, and prevent permanent damage.
Meeting the Needs of a Growing Elderly Population
Stephanie Tedford, Clark’s daughter and Lumithera’s director of medical and science affairs, highlighted the significance of Valeda’s approval for the local community. “With a growing elderly population in Kitsap County, it’s exciting to have a small company here offering the first and only approved treatment for this disease.”
The therapy consists of nine sessions over five weeks, with each session lasting approximately four minutes. Conducted in optometry or ophthalmology offices, the treatment promotes sustained energy production in the eye for up to six months. Patients can return for additional sessions if their vision shows signs of decline.
Innovating for the Future
Lumithera employs around 40 people locally and collaborates with consultants worldwide. The company plans to expand its use of light therapy to treat other conditions, including diabetic retinopathy.
“While the concept of using light to stimulate tissue may seem simple, the underlying biology is complex,” Tedford noted. “Energy is the currency of everything, and improving tissue health at a cellular level is no small task.”
With the success of Valeda, Lumithera is optimistic about the future of light-based therapies. “We believe the opportunities are vast and extend far beyond what we’ve accomplished so far,” Tedford said.
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