A ray of hope has emerged for millions struggling with age-related macular degeneration (AMD), a leading cause of vision loss. The U.S. Food and Drug Administration (FDA) has cleared the path for a novel device, the Valeda Light Delivery System, to be used as a treatment for dry AMD. This groundbreaking approval marks the first therapeutic option specifically designed to address this common form of the disease.
Dry AMD, which affects approximately 70% to 90% of AMD cases, progressively damages the center of the retina, the light-sensitive tissue at the back of the eye. While dry AMD has been a significant challenge for ophthalmologists, the Valeda device presents a promising new approach.
The device, developed by LumiThera, employs three LEDs that emit light at specific wavelengths within the yellow, red, and near-infrared portions of the electromagnetic spectrum. These wavelengths are believed to positively impact the mitochondria, the powerhouses of cells within the retina. In dry AMD, mitochondrial function often falters, leading to cellular damage.
Scientific evidence suggests that this targeted light exposure can revitalize the mitochondria’s ability to produce energy and repair cellular damage. Furthermore, the light may trigger the release of chemicals that enhance blood flow to the retina, simultaneously reducing inflammation.
The FDA’s approval was based on a comprehensive clinical trial involving 100 participants with early or intermediate stages of dry AMD. The results demonstrated significant improvement in visual acuity for those treated with the Valeda device compared to those who received a sham treatment.
On average, treated eyes showed an improvement of at least five letters on an eye chart, equivalent to one full line, which is a notable improvement. These improvements were observed halfway through the study and again at its conclusion, indicating the benefits may persist over time.
Beyond improved vision, the Valeda device also exhibited a lower percentage of treated eyes progressing to the most advanced stage of AMD. Only about 7% of treated eyes worsened, compared to 24% of the placebo group. Additionally, the study observed that drusen, protein and fat deposits that accumulate under the retina as AMD progresses, didn’t grow larger in treated eyes, unlike those in the untreated group.
The FDA’s authorization of the Valeda Light Delivery System signifies a significant leap forward in the management of dry AMD. This innovative treatment option holds the potential to improve vision and slow disease progression, offering hope and a new path for those living with this condition.
