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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 that degenerates the center of the retina and can lead to vision loss, but Valeda therapy has been shown to shine light into the eye to repair retinal damage and potentially improve vision. Masu.
LumiThera Obtains FDA Authorization of Valeda Treatment for Dry AMD Patients to Improve Vision | LumiThera US
https://www.lumithera.com/lumithera-obtains-fda-authorization-of-valeda-treatment-for-dry-amd-patients-to-improve-vision/
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Dry AMD is the leading cause of vision loss in people over 55 years of age in developed countries. Valeda therapy is the first FDA-approved treatment for vision-impaired patients with dry AMD.
In dry AMD, mitochondria are malfunctioning, and previous research has shown that exposure to yellow, red, and near-infrared wavelength light increases mitochondrial activation energy and increases their ability to repair damage. It was suggested.
By emitting light at three relevant wavelengths, Valeda therapy encourages mitochondria to release chemicals that promote blood flow in the retina, and at the same time may suppress inflammation.
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The developer, LumiThera, conducted a clinical trial on 100 patients with early to intermediate dry AMD. Ninety-one of the subjects’ eyes were treated with Valeda therapy and 54 received sham treatment. Treatment was repeated three times a week for three to five weeks 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. Treatment effects were confirmed both midway through and at the end of the study, so visual improvements are expected to last at least 24 months.
Additionally, compared to eyes that received sham treatment, AMD progressed less in eyes treated with Valeda, with only about 7% of eyes experiencing worsening of symptoms compared to 24% in the sham group. Ta.
“For several years, we have been working to bring Valeda, a multiwavelength optical biocontrol device, to patients in the United States,” said Dr. Clark Tedford, president and CEO of LumiThera. FDA approval of Valeda to improve vision in dry AMD is huge for patients in the United States. It’s a choice.”
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