LumiThera Inc. has announced promising topline results from its LIGHTSITE IIIB extension trial, demonstrating sustained vision benefits for patients with dry age-related macular degeneration (AMD) treated with the Valeda Light Delivery System over a 4.5-year period.
The Valeda system, which received FDA authorization in November 2024, is the first treatment approved to improve vision in dry AMD patients. The non-invasive therapy uses photobiomodulation (PBM) to deliver select wavelengths of light that enhance mitochondrial function and improve cellular energy production at the disease's cellular level.
"There is now a non-invasive treatment for dry AMD patients that can improve vision and address the disease earlier, before permanent vision loss," said Clark Tedford, PhD, President and CEO of LumiThera. "The extended trial results demonstrate that Valeda is potentially modifying the trajectory of vision loss in dry AMD patients and can offer sustainable benefits over several years with continued treatment."
Extended Vision Benefits Demonstrated
The LIGHTSITE IIIB extension trial followed subjects who had completed the pivotal LIGHTSITE III trial and resumed treatment for an additional 13 months. The extension study results were presented on May 7th at the 2025 Meeting of the Association for Research in Vision and Ophthalmology (ARVO) by co-investigators from Stanford University.
In the original pivotal U.S. LIGHTSITE III trial, Valeda met its primary endpoint by demonstrating an improvement in best corrected visual acuity (BCVA) of more than 5 letters (equivalent to one line improvement on the eye chart) over 24 months of treatment.
The extension trial now shows these benefits can extend to 4.5 years with continued treatment. Notably, the follow-up included a 20-month period without treatment between the two trials, during which patients still maintained some vision benefit from the earlier pivotal trial and recovered vision upon retreatment in the extension study.
"The LIGHTSITE IIIB extension trial results extend two-year pivotal trial vision benefits out to 4.5 years and showed an excellent safety profile," stated David Boyer, MD, FASRS, of Retina Vitreous Associates Medical Group in Beverly Hills, California. "This is very exciting data for early to intermediate dry AMD patients."
Significant Clinical Implications
Quan Dong Nguyen, MD, MSc, FARVO, FASRS, Professor of Ophthalmology, Medicine, and Pediatrics at Stanford University School of Medicine, highlighted the significance of the findings: "After another 13 months of treatment, although the size of the study population of LIGHTSITE IIIB is relatively small, more than 60% of the subjects that received Valeda treatment in both studies were still showing a benefit in vision of over one line."
Dr. Nguyen added, "What is exciting is this is the first and only FDA-authorized treatment that can improve vision with extended benefits out to 4.5 years, suggesting that earlier and extended treatment provides the best outcomes."
Treatment Specifications and Patient Selection
Valeda is intended for patients with a best corrected visual acuity of 20/32 through 20/70 who have dry AMD characterized by at least three medium drusen (>63 μm and ≤125 μm in diameter), large drusen (>125 μm in diameter), or non-central geographic atrophy, and the absence of neovascular maculopathy or center-involving geographic atrophy.
The treatment has been shown to improve mean visual acuity by approximately one line (ETDRS) compared to those not receiving treatment after approximately two years.
Addressing a Major Public Health Challenge
AMD is a leading cause of central vision loss in people over 55 in developed countries. The overall prevalence of AMD increases dramatically 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).
Losing central vision can significantly impact quality of life, making it harder to see faces, drive, or perform close-up work like cooking or household tasks. Until now, treatment options for dry AMD have been limited, particularly for early to intermediate stages of the disease.
About LumiThera's Technology Platform
In addition to Valeda, LumiThera offers a comprehensive approach for detecting, treating, and monitoring retinal diseases through its diagnostic portfolio. This includes the AdaptDx Pro, a portable dark adaptometer utilizing artificial intelligence to detect rod-mediated dysfunction (one of the first functional signs of retinal disease), and the NOVA Vision Testing System, a comprehensive electrophysiology platform for assessing visual and neuro-visual disorders.
The Valeda Light Delivery System is CE Marked in the European Union, UKCA Marked in the UK, and available in select countries in Latin America, in addition to its recent FDA authorization in the United States.
