LumiThera Inc., based in Seattle, Washington, USA, has recently received the U.S. Food & Drug Administration (FDA) authorisation, marketing for “Valeda Light Delivery System” for treatment of patients with dry age-related macular degeneration (AMD). According to the company, their Valeda therapy is the first ever authorized treatment by the FDA for vision loss in dry AMD patients, providing “an improvement in best corrected visual acuity (BCVA) over 24 months of >5 letters or equivalent to a line on the eye chart. In the pivotal U.S. LIGHTSITE III trial, the Valeda treatment met its primary endpoint and was shown to be safe and effective in increasing and maintaining improved visual acuity.” Valeda is CE Marked in the EU and is available in select countries in Latin America.
The “LIGHTSITE III” study was conducted by a multi-centre clinical trial in dry age-related macular degeneration (AMD). The photo-biomodulation (PBM) device is aimed to activate mitochondrial respiratory chain components resulting “in stabilization of metabolic function and initiation of a signalling cascade, which promotes cellular proliferation and cytoprotection”, according to the company. Previously, in the EU, the medical device developed a CE mark to use wavelengths of light in the far red to near infrared spectrum (590, 660 and 850 nm) to modulate biologic function through direct and indirect cellular effects on mitochondrial respiratory chain components. PBM activation “of photo-acceptors in the mitochondria improves generation of adenosine triphosphate (ATP), modulates the production of intracellular signalling molecules such as reactive-oxygen species (ROS) and nitric oxide (NO), and triggers secondary effects that produce sustained changes in cell function and viability”.
Non-invasive painless treatment for DRY AMD – According to Progressive Vision, treatment options for Dry AMD have been limited to dietary supplements and lifestyle interventions. However, the new and only available treatment for Dry AMD is here, using a safe, non-invasive and painless therapy – photobiomodulation. The Valeda Light Delivery System (LDS) provides a direct treatment for Dry Age – Related Macular Degeneration (https://www.progressivevision.ie/valeda/)
According the US authorisation, LumiThera submitted the US LIGHTSITE III clinical data as part of a technical package to the FDA under a “De Novo” request with special controls. Lori Holder, Vice President, Regulatory Affairs, LumiThera, Inc. stated that, “the De Novo authorization established Valeda as the first device for treatment of dry AMD patients with vision loss and creates a threshold for this novel class of PBM devices that must show similar clinical and nonclinical performance controls equivalent to the Valeda Light Delivery System.” In addition, David Boyer, MD, Retina Vitreous Associates Medical Group, Beverly Hills, CA commented that, “the RCT results demonstrated clinical benefits in early to intermediate dry AMD patients out to 24 months and an excellent safety profile. Patients will now be able to try a non-invasive treatment that can help improve their vision earlier in the disease process.” The Duke Reading Center also reported that the PBM treatment had a beneficial effect on multiple anatomic biomarkers finding that, “that incident geographic atrophy (GA) was reduced in the PBM-treated eyes compared to the sham treated eyes respectively, 6.8% versus 24%. Although incident GA was not a prespecified clinical endpoint, the results supported overall safety benefits of treating earlier in dry AMD disease.”