The Valeda® Light Delivery System is the first and only FDA-authorized treatment for early and intermediate dry age-related macular degeneration (AMD).
Authorized by the U.S. Food and Drug Administration on November 4, 2024, Valeda delivers a non-invasive, in-office therapy called photobiomodulation (PBM) — also known as red light therapy — that uses precise wavelengths of light to support the health of retinal cells. Clinical trials have shown that Valeda PBM can improve and preserve vision in patients with dry AMD. At Miramar Eye Specialists, we are proud to offer this groundbreaking treatment to help patients across Ventura County protect their sight before advanced vision loss occurs.
Valeda is a light-based therapy that delivers three carefully selected wavelengths of light — amber (590 nm), red (660 nm), and near-infrared (850 nm) — to the eye through Light Emitting Diodes (LEDs). It is important to understand that Valeda is not a laser. The LEDs are very low-powered, do not cause heat damage to the eye, and have been shown to be safe and well-tolerated. Photobiomodulation has been used safely across many areas of medicine for decades, and Valeda is the first device of its kind designed specifically for treating dry AMD — and the only one to demonstrate meaningful vision improvement in clinical trials. The device has been used in Europe since 2019, with more than 800,000 treatments performed worldwide.
Dry AMD damages the cells of the macula, the central part of the retina responsible for sharp, detailed vision. As these cells become less efficient, vision gradually declines. Valeda PBM works at the cellular level by activating cytochrome c oxidase, an essential component of the mitochondria. This stimulation enhances the production of adenosine triphosphate (ATP) — the cell’s primary source of energy — while improving local oxygenation, encouraging vasodilation, and helping reduce the chronic inflammation that contributes to disease progression. The result is healthier retinal cells better equipped to maintain or recover function.
The Valeda Light Delivery System is indicated for patients with best-corrected visual acuity (BCVA) between 20/32 and 20/70 who have dry AMD characterized by at least three medium drusen (greater than 63 µm and up to 125 µm in diameter), large drusen (greater than 125 µm in diameter), or non-central geographic atrophy — and the absence of neovascular (wet) maculopathy or center-involving geographic atrophy. This makes Valeda especially valuable for patients in the early and intermediate stages of dry AMD, a population that historically had no approved treatment options.
Patients should not receive Valeda if they have a known photosensitivity to yellow, red, or near-infrared light; a history of light-activated central nervous system disorders such as epilepsy or migraine; or if they have used photosensitizing medications within the past 30 days. Your retina specialist at Miramar Eye Specialists will determine whether Valeda is the right option for you.
Valeda PBM is one of the most patient-friendly treatments in modern retinal care. There are no injections, no anesthesia, no eye dilation, and no speculum. You will simply be seated comfortably at the Valeda Light Delivery System — which looks similar to the devices used for routine vision testing — while your eye care team guides you through each step. Each session takes approximately four minutes per eye (under ten minutes total for both eyes) and is completely painless. A standard course consists of nine sessions administered three times per week over a three- to five-week period. To maintain the benefits, treatment series are typically repeated every four to six months. There is no recovery time, and most patients return to normal activities immediately.
The safety and effectiveness of Valeda PBM have been studied extensively in the LIGHTSITE I, II, and III clinical trials. In the pivotal LIGHTSITE III study — a 24-month, multicenter, randomized, sham-controlled trial — patients treated with Valeda gained an average of approximately one line of visual acuity (ETDRS) compared to baseline at both 13 and 21 months, with the benefit maintained at month 24. Approximately 64% of PBM-treated eyes gained at least one line of vision at month 24 compared to baseline. The trial also showed reduced drusen volume and significantly slower progression to geographic atrophy in treated eyes versus the sham group. More than 97% of patients reported no pain or discomfort during treatment, and extension data (LIGHTSITE IIIB) has demonstrated sustained vision benefits out to 4.5 years with continued treatment.
Until the introduction of Valeda PBM, patients diagnosed with early or intermediate dry AMD had no approved treatment to slow disease progression or improve vision — treatment was typically delayed until the disease advanced and irreversible vision loss had already occurred. Valeda changes that paradigm. By intervening earlier, before significant damage to the macula develops, patients have the opportunity to maintain better visual function for longer and potentially delay or avoid progression to advanced stages of AMD, including wet (neovascular) AMD or central geographic atrophy. As with most retinal conditions, early detection and proactive care offer the best outcomes.
Valeda Photobiomodulation received FDA authorization in November 2024, and Medicare now provides coverage for eligible patients. Our team will gladly verify your benefits before treatment and give you a clear, written breakdown of any remaining out-of-pocket cost, so you can begin with full confidence in both your care and your costs.
If you have been diagnosed with dry age-related macular degeneration, or you have a family history of AMD and want to learn more about your treatment options, the retina specialists at Miramar Eye Specialists can help. We offer Valeda Photobiomodulation as part of our comprehensive approach to retinal care — alongside advanced diagnostics, clinical research, and the latest medical and surgical therapies. Request an appointment today to find out if Valeda PBM is right for you.
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