Poulsbo firm gets FDA OK to treat common eye problem

Clark Tedford has been smiling so much he said his jaw is starting to hurt.

He has good reason to be happy – his company, Lumithera in Poulsbo, a family-owned medical device company, recently received word that the Food and Drug Administration has approved their new product, Valeda, a non-invasive treatment for degenerative eye disease.

“The target we’re going after, age-related macular degeneration, is the largest cause of vision loss in adults over the age of 65,” said Tedford, who has a doctorate in pharmacology. “There aren’t a lot of alternatives for these patients, and over years they’ll lose their vision slowly, and it can be devastating.”

Tedford said that Lumithera has developed a light-based approach to stimulate retinal tissue to improve blood flow and energy production. “We’ve done five different clinical trials, and the last one was pivotal and was submitted to the FDA,” he said.

The company received approval in early November. “We can now start to allow our patients in the U.S. the opportunity to get treated.”

Valeda has already been approved in Latin America and has been in use in Europe for four years.

Light therapy has a long history of safe, effective therapies, Tedford said. Used in everything from treating jaundice in newborns to back pain and tendonitis, to diabetic wounds that don’t heal properly, it is a non-invasive treatment that limits inflammation and promotes regrowth of tissue.

“Your eye requires a lot of energy,” Tedford said. “As you grow older, you become more susceptible to some of these age-related eye diseases. Part of it is because your eye is more energy-demanding, and it has difficulty keeping up with what you could do when you were 20 or 30 years old.”

Valeda’s primary indication is for dry AMD, which is caused by eye tissue known as the macula, deteriorating over time. “We can treat earlier in the disease, and since it can be identified earlier because symptoms arise slowly, now we have something with which we can begin to treat earlier as well.” Tedford said that since AMD is slow growing, early treatment can prolong vision, prevent scarring and permanent damage.

“There’s a growing elderly population here in Kitsap,” said Stephanie Tedford, Clark’s daughter and director of medical and science affairs for Lumithera. “So, it’s exciting to have a small company here in the area that has the first and only approved treatment for this disease.”

Valeda is used in a treatment that lasts about four minutes in each session. About nine treatments are done over five weeks. “The therapy sustains energy development for about four to six months, and if you notice a change, you can come back in and be treated again.” Treatments take place in an optometrist or ophthalmologist’s office.

The technology is complicated, Tedford said. “It’s taken us a little bit of time to get here. It seems simple, we use light to stimulate the tissue. But the reality is that you’re trying to make the tissue healthier to make more energy. Energy is the currency of everything, and so the biology becomes very complex.”

Lumithera has about 40 employees locally, but works with consultants around the world, and is growing. Tedford said the company will continue to use light therapy to provide treatments for other eye diseases such as diabetic retinopathy. “We think that the opportunities are large for this to expand beyond what we’ve done so far,” he said.