-LumiThera Inc., a medical device company offering photobiomodulation (PBM) treatment for ocular damage and disease, today announced an update on the regulatory status of the Valeda Light Delivery System.
Following 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.
The De Novo request is reflective of 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.
LumiThera submitted the US LIGHTSITE III clinical data as part of a technical package to the FDA under a Premarket Approval (PMA) application in 2023. Upon completion of the initial review, the FDA 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 180 day 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 US market introduction by mid-2024 if successful.
“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,” stated Lori Holder, vice president, Regulatory Affairs, LumiThera. “Our discussions with the FDA has indicated this is the correct path forward for LumiThera’s treatment for dry AMD patients.”
“The LIGHTSITE series of trials demonstrated improvements of visual benefits with PBM treatments, sustained out to 24 months in prospective randomized clinical trials (RCT),” stated René Rückert, MD, MBA, CMO, LumiThera. “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.”
“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,” stated Clark Tedford, PhD, president and CEO. “The safety and efficacy of PBM treatment in early to late stage dry AMD provides a significant benefit to patients.”