The U.S. Food and Drug Administration (FDA) has authorized the LumiThera Valeda Light Delivery System as the first treatment for vision loss caused by dry age-related macular degeneration (AMD). Approved under the FDA's "De Novo" process, this innovative therapy utilizes photobiomodulation (PBM) to deliver specific wavelengths of light to the retina, aiming to improve cell survival and slow down the progression of the disease. Conducted over a 24-month period, a study involving 100 participants across 10 retinal centers in the United States demonstrated its safety and effectiveness.
Photobiomodulation, the core of the LumiThera treatment, plays a crucial role in cellular function by stimulating an enzyme in eye cells vital for maintaining healthy vision. By increasing mitochondrial energy production, reducing inflammation, and enhancing nutrient and oxygen supply, PBM helps prevent oxidative stress, which can damage retinal pigment epithelial cells and lead to AMD. This therapy marks a significant advancement in medical devices, differing from existing options on the market.
Dry AMD is a leading cause of blindness in adults over 55, affecting approximately 20 million people in the United States. It accounts for 90% of diagnosed cases, underscoring the importance of developing new treatments. While existing injections like Syfovre and Izervay can slow the progression of geographic atrophy by about 14%-20%, they come with a higher risk of transitioning to wet AMD. The LumiThera Valeda Light Delivery System offers an alternative approach, aiming to reduce the risk of vision loss and delay the onset of geographic atrophy.
The clinical trial conducted by LumiThera provided initial evidence of the treatment's efficacy. However, Dr. Jason M. Miller, MD, PhD, expressed caution regarding its immediate adoption.
“The placebo effect in medicine is just rampant. It accounts for, in some trials, 30% to 40% of an effect. … I would have a hard time buying this device right now. I don’t want to say it’s ineffective, I just want more data,” – Jason M. Miller, MD, PhD
Dr. Miller also highlighted skepticism about the widespread claims surrounding light therapy's benefits.
“Google photobiomodulation or light therapy, and you'll find it's supposed to fix everything … people try to sell it for everything, and that's because they own the equipment, and they're looking to recoup their costs,” – Jason M. Miller, MD, PhD
Despite these reservations, Dr. Eleonora Lad, MD, PhD, sees potential for the treatment to transform patient care.
“This … treatment will have a huge impact on the standard of care of patients with dry AMD because it will allow retina specialists and practitioners to intervene at earlier stages before photoreceptor loss is irreversible, before the late-stage disease,” – Eleonora Lad, MD, PhD
The study supporting the LumiThera Valeda Light Delivery System's FDA approval serves as a foundation for further research. While it signifies a breakthrough in treating dry AMD, continued investigation is necessary to confirm its long-term effectiveness and broaden its acceptance among medical professionals.
Dry AMD poses a significant challenge due to its prevalence and lack of effective treatments. It is crucial that new therapies not only offer hope but also demonstrate clear advantages over existing options. The LumiThera system represents a step forward in addressing this unmet medical need by providing an innovative solution that could change how dry AMD is managed.
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