U.S. Food and Drug Administration approves medical device that shines light into the eye to treat retinal damage that can lead to blindness
The U.S. Food and Drug Administration (FDA) has approved Valeda therapy, which uses the Valeda Light Delivery System developed by medical device manufacturer LumiThera, as a treatment for dry age-related macular degeneration (AMD). AMD is a disease in which the center of the retina degenerates, and as it progresses, it can cause loss of vision. However, Valeda therapy has been shown to repair retinal damage by shining light into the eye, potentially improving vision.
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Dry AMD is the leading cause of vision loss in people over 55 in the developed world. Valeda is the first FDA-approved treatment for patients with vision loss caused by dry AMD.
Previous research has suggested that in dry AMD, mitochondria are dysfunctional, and exposure to light with wavelengths corresponding to yellow, red, and near-infrared light increases the production of energy for mitochondrial activity and increases the ability to repair damage.
Valeda therapy emits light at three wavelengths that stimulate mitochondria to release chemicals that increase blood flow to the retina and may also suppress inflammation.
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LumiThera, the company behind the product, conducted a clinical trial on 100 patients with early to intermediate dry AMD, with 91 eyes treated with Valeda therapy and 54 receiving a placebo treatment. Treatments were administered three times a week for three to five weeks, repeated every four months for two years.
As a result of the treatment, the eyes treated with Valeda therapy were able to see five or more letters or one line higher on the visual acuity chart compared to before treatment. The effects of the treatment were confirmed both midway through and at the end of the study, so the improvement in vision is expected to last for at least 24 months.
Additionally, compared with the placebo-treated eyes, AMD progression was less severe in the Valeda-treated eyes, with only about 7 percent of eyes experiencing a worsening of symptoms compared with 24 percent of the placebo-treated eyes.
'We have been working for several years to bring our Valeda multi-wavelength photobiomedicine device to American patients,' said Dr. Clark Tedford, president and CEO of LumiThera. 'We now have a non-invasive treatment option that can improve vision for patients with dry AMD and prevent them from losing their vision permanently. The FDA approval of Valeda to improve vision in dry AMD is a great option for American patients.'
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