LumiThera Inc., a medical device company specializing in photobiomodulation (PBM) therapy for ocular conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for its Valeda® Light Delivery System. The system is approved for the treatment of dry age-related macular degeneration (AMD), a leading cause of central vision loss in individuals over the age of 55 in developed countries.
LumiThera Inc., an ophthalmic medical device company specializing in photobiomodulation (PBM) therapy, today announced that the U.S. Food and Drug Administration (FDA) has granted marketing authorization for its Valeda® Light Delivery System, the first FDA-approved treatment for vision loss in patients with dry age-related macular degeneration (AMD). The Valeda therapy demonstrated a clinically meaningful improvement in best corrected visual acuity (BCVA), with a gain of more than 5 letters, or the equivalent of one line on the eye chart, over 24 months. This breakthrough was confirmed in the pivotal LIGHTSITE III trial, where Valeda met its primary endpoint and was shown to be both safe and effective in enhancing and maintaining visual acuity.
LumiThera’s submission to the FDA included clinical data from the U.S. LIGHTSITE III study as part of a De Novo request with special controls. The approval establishes Valeda as the first device approved for treating vision loss in dry AMD patients and sets a new standard for this innovative class of PBM devices, requiring similar clinical and nonclinical performance for future products.
Lori Holder, Vice President of Regulatory Affairs at LumiThera, noted, “This De Novo authorization not only makes Valeda the first FDA-approved device for treating dry AMD but also sets a benchmark for other PBM devices targeting this condition.”
The study’s results were praised by retinal experts for demonstrating significant benefits in early to intermediate dry AMD patients. Dr. David Boyer of Retina Vitreous Associates Medical Group in Beverly Hills, CA, commented, “This is a groundbreaking, non-invasive treatment option for patients in the earlier stages of dry AMD, offering a promising way to improve vision before permanent loss occurs.”
Dr. Glenn Jaffe of the Duke Reading Center added, “While the primary endpoint of the study focused on visual acuity, we also assessed multiple anatomical markers. Notably, the treatment showed a positive effect on reducing the progression to geographic atrophy (GA), with incidence in the treated eyes being 6.8% compared to 24% in the control group. These findings suggest that PBM could help preserve retinal anatomy and prevent further disease progression in dry AMD patients.”
Clark Tedford, Ph.D., President and CEO of LumiThera, stated, “We are thrilled to bring Valeda to U.S. patients after years of hard work. The FDA’s approval of Valeda provides a new, non-invasive treatment option for dry AMD that could improve vision and help address the disease earlier, before it leads to permanent vision loss.”
About AMD
Age-related macular degeneration (AMD) is a leading cause of vision loss in individuals aged 65 and older. It primarily affects central vision, making everyday activities like reading, driving, and recognizing faces difficult. The prevalence of AMD increases significantly with age, rising from 4.2% in people aged 45–49 to 27.2% in those aged 80–85. Globally, the number of people affected by AMD is expected to rise by 20% between 2020 and 2030, from 195.6 million to 243.3 million.
About LumiThera
LumiThera, Inc. is at the forefront of ophthalmic photobiomodulation (PBM) technology, offering innovative solutions to detect, treat, and monitor retinal diseases, particularly dry AMD.
The Valeda® Light Delivery System is LumiThera’s flagship product and is FDA-approved for improving vision in dry AMD patients. The system is also CE Marked in the EU and available in select Latin American countries.
In addition, LumiThera offers the AdaptDx Pro®, a portable dark adaptometer utilizing AI to detect impaired dark adaptation, the earliest biomarker for dry AMD, up to three years before clinical symptoms appear. The AdaptDx Pro is available in the U.S. and Canada.
The company also offers the NOVA Vision Testing System, a comprehensive electrophysiology platform for diagnosing visual and neuro-visual disorders, available in the U.S. and select international markets.
