LumiThera Provides Update on FDA Review for Valeda Light Delivery System

LumiThera provided an update on the regulatory status of the Valeda Light Delivery System, revealing that, in response to feedback from the FDA, a De Novo request has been submitted for the reclassification of the system as a Class II device.

The De Novo request process offers the possibility of officially classifying the Valeda Light Delivery System as a Class II device with specific controls. LumiThera emphasizes that this approach, tailored to the benefit-to-risk profile, enables novel devices to enter the market while maintaining safety and efficacy through the implementation of special controls.

In 2023, LumiThera submitted the US LIGHTSITE III clinical data to the FDA as part of a premarket approval (PMA) application. Following the initial review, the FDA determined that pursuing a De Novo request for Class II classification with special controls would be the optimal route to market.

Notably, the FDA's review timeline for the De Novo application is 150 days, in contrast to the 180-day duration for a PMA, excluding additional time for interactive review. LumiThera, having proposed special controls in the De Novo request, is optimistic about the potential approval, aiming for a mid-2024 introduction to the US market if the process proves 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,” Lori Holder, Vice President, Regulatory Affairs, LumiThera, said in a company news release. “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, Chief Medical Officer, 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.”