LumiThera has released promising new topline data for its Valeda Light Delivery System, showing sustained improvement in vision for patients with dry age-related macular degeneration (AMD). The results, presented at the Association for Research in Vision and Ophthalmology (ARVO) 2025 meeting in Salt Lake City, demonstrate the potential of this non-invasive treatment approach to address a significant unmet need in ophthalmology.
The Valeda Light Delivery System received authorization from the U.S. Food and Drug Administration (FDA) in November 2024, making it the first non-invasive treatment approved for dry AMD, the most common form of the condition and a leading cause of vision loss in people over 60 across Europe and North America.
Innovative Photobiomodulation Technology
LumiThera's device employs photobiomodulation, a therapeutic approach that uses specific wavelengths of light to stimulate retinal cells, improving cellular function in patients with dry AMD. This mechanism aims to delay disease progression by enhancing the performance of compromised retinal tissue.
The LIGHTSITE IIIB study (NCT06229665) enrolled 75 subjects with dry AMD across seven clinical sites in the United States. This open-label, prospective, multi-center extension study followed patients who had initially participated in the LIGHTSITE III pivotal trial, providing valuable long-term efficacy data.
Significant and Sustained Vision Improvements
Patients in the trial received nine treatments with the Valeda system over a three-to-five-week period. According to the study protocol, subjects will undergo additional nine-treatment cycles at the four-month, eight-month, and twelve-month timepoints.
The results demonstrated an improvement in best corrected visual acuity (BCVA) for 24 months of more than five letters—equivalent to gaining "one line" of vision on a standard eye chart. This represents a clinically meaningful improvement for patients with a progressive, vision-threatening condition.
"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," said Dr. Quan Dong Nguyen, study co-investigator and professor at the Byers Eye Institute at Stanford University.
Long-Term Benefits and Treatment Durability
Dr. Nguyen noted that despite the relatively small study population, the results showed remarkable consistency. After 13 months, more than 60% of subjects who received Valeda treatment across both the original LIGHTSITE III study and this extension trial continued to show vision benefits of "over one line" on an eye chart.
This durability of response is particularly significant for dry AMD patients, who previously had limited treatment options to preserve their vision. The condition causes the macula—the central part of the retina responsible for sharp, central vision—to gradually break down, eventually resulting in vision loss that impacts daily activities like reading, driving, and facial recognition.
Addressing a Major Public Health Challenge
Dry AMD represents a substantial public health challenge as the population ages. As the leading cause of visual impairment in patients aged 60 and above across Europe and North America, effective treatments are urgently needed to maintain quality of life and independence for affected individuals.
The Valeda Light Delivery System's non-invasive approach offers a significant advantage over other potential treatments that may require injections or surgical intervention. The treatment can be administered in an outpatient setting, potentially improving patient compliance and reducing the burden on healthcare systems.
The ongoing LIGHTSITE IIIB study will continue to gather data on the long-term efficacy and safety of the Valeda system, with additional treatment cycles and follow-up assessments planned through the 12-month timepoint. These results will further inform clinical practice and treatment guidelines for managing dry AMD patients with this novel therapeutic approach.
