If granted, this device would be assigned an official classification as a Class II device with special controls.
LumiThera Inc. provided an update on the regulatory status of the Valeda® Light Delivery System. After receiving feedback from the FDA, a De Novo request to reclassify the Valeda Light Delivery System as a Class II device has been submitted for review. Under the De Novo request process, the Valeda Light Delivery System can be assigned an official classification as a Class II device with special controls. This type of request reflects the benefit to risk profile and allows for novel devices to reach the market and provides for special controls to maintain the safety and efficacy of the device.
In 2023, LumiThera submitted the US LIGHTSITE III clinical data as part of a technical package to the FDA under a Premarket Approval (PMA) application. The FDA completed an initial review and determined the best path to market would be to submit a De Novo request requesting classification of the device as a Class II with special controls. The FDA review time for the De Novo application is 150 days versus the 180 days for a PMA, not including additional time for interactive review. The Company proposed special controls as part of the De Novo request submission and could anticipate the FDA granting the De Novo request enabling introduction to the US market by mid-2024.
In the news release, Lori Holder, Vice President, Regulatory Affairs, LumiThera commented on this pathway and classification saying, “The De Novo classification is a special pathway for novel devices versus the PMA route, and establishes a threshold for this novel class of PBM devices that must show similar clinical and nonclinical performance controls similar to the Valeda Light Delivery System. Our discussions with the FDA has indicated this is the correct path forward for LumiThera’s treatment for dry AMD patients.”
Also in the release, René Rückert, MD, MBA, Chief Medical Officer, LumiThera shared the benefits of this device and the hope that it will be classified and available for commercial use in the US, saying, “The LIGHTSITE series of trials demonstrated improvements of visual benefits with PBM treatments, sustained out to 24 months in prospective randomized clinical trials (RCT). The RCT results demonstrated clinical benefits in early to intermediate patients out to 24 months with anatomical evidence of slowing of AMD disease progression and an excellent safety profile. The classification by the FDA mirrors what has been seen in clinical trials and commercial use in Europe and Latin America over the last few years.”
Clark Tedford, PhD, President and CEO of LumiThera noted the safety and efficacy of the treatment for those with dry AMD: “Valeda, a multiwavelength photobiomodulation device, is a non-invasive treatment option for dry AMD patients that may improve vision and address the disease earlier, before permanent vision loss. The safety and efficacy of PBM treatment in early to late-stage dry AMD provides a significant benefit to patients.”