January 03, 2024 07:12 AM Eastern Standard Time
SEATTLE–(BUSINESS WIRE)–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, 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.”
“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, Ph.D., President and CEO. “The safety and efficacy of PBM treatment in early to late stage dry AMD provides a significant benefit to patients.”
AMD is a leading cause of vision loss for people aged 65 and older. Losing central vision can make it harder to see faces, drive, or do close-up work like cooking or fixing things around the house. The overall prevalence of AMD is estimated to increase 7-fold with age, from 4.2% in those aged 45–49 years, to 27.2% in those aged 80–85 years. Globally, the prevalence is estimated to increase by 20% between 2020 (195.6 million) and 2030 (243.3 million).
LumiThera, Inc. is a medical device company focused on diagnosing, treating, and monitoring ocular disease and damage including dry age-related macular degeneration (AMD), a leading cause of blindness in adults over 65.
LumiThera’s flagship product, the Valeda® Light Delivery System, uses multiwavelength photobiomodulation to treat dry AMD patients. Valeda is CE Marked in the EU and is available in Europe and in countries in Latin America. Valeda is not yet approved by the Food & Drug Administration (FDA).
AdaptDx Pro® dark adaptation functional testing technology enables eye care professionals to detect and monitor AMD three years before clinical presentation. AdaptDx Pro is listed on the FDA’s Establishment Registration & Device Listing.
Diopsys ERG and VEP systems help eye care professionals analyze the entire pathway for visual and neuro-visual disorders. VEP is FDA-cleared. ERG and VEP are available in select countries outside of the USA.
LumiThera’s AMD Excellence Program® provides customer implementation, training, best practices, and ongoing support across all brands.
For more information on the Valeda® Light Delivery System please visit www.lumithera.com. The AdaptDx Pro and Diopsys ERG and VEP systems are available separately through LumiThera Diagnostics, Inc. and Diopsys, Inc.