LumiThera's Valeda Light Delivery System Shows Extended Vision Benefits in Dry AMD Patients Over 4.5 Years
• LumiThera's Valeda Light Delivery System, FDA-authorized in November 2024, demonstrated sustained vision improvement of over one line on the eye chart in more than 60% of dry AMD patients through 4.5 years of follow-up.
• The LIGHTSITE IIIB extension trial results showed that patients maintained some vision benefits during a 20-month treatment gap and recovered vision upon retreatment, suggesting the therapy may modify disease trajectory.
• As the first non-invasive treatment authorized to improve vision in dry AMD, Valeda uses photobiomodulation to enhance mitochondrial function at the cellular level, offering a treatment option before permanent vision loss occurs.
LumiThera's Valeda Light Delivery System Shows Sustained Vision Improvement in Dry AMD Patients
• LumiThera's Valeda Light Delivery System, the first FDA-authorized non-invasive treatment for dry AMD, demonstrated sustained vision improvement of more than 5 letters on eye charts over 24 months in the LIGHTSITE IIIB extension study.
• The photobiomodulation device showed promising results with over 60% of subjects maintaining vision benefits after 13 months of treatment, with extended benefits observed up to 4.5 years.
• Results from the multi-center trial involving 75 dry AMD patients were presented at the ARVO 2025 meeting, highlighting the potential for earlier and extended treatment to provide optimal outcomes for this leading cause of vision loss in older adults.
Boehringer Ingelheim Launches Phase II Trial of First-in-Class Oral Treatment for Geographic Atrophy
• Boehringer Ingelheim has initiated the JADE Phase II clinical study to evaluate BI 1584862, a potential first-in-class oral treatment for geographic atrophy, a severe form of age-related macular degeneration.
• Geographic atrophy affects over 5 million people worldwide with more than 40% considered legally blind, creating a significant unmet need for treatments that can slow disease progression and preserve vision.
• The company is simultaneously advancing a second compound, BI 771716, an antibody fragment designed to penetrate retinal layers, demonstrating Boehringer's dual-pathway approach to addressing this debilitating eye condition.
FDA Approves Light Therapy System for Dry Age-Related Macular Degeneration
• The FDA has granted marketing authorization to LumiThera's Valeda Light Delivery System, a photobiomodulation (PBM) system, as the first treatment for dry age-related macular degeneration (AMD).
• The LIGHTSITE III trial demonstrated that the PBM system improved vision in patients with early AMD, with nearly 60% achieving a >5-letter gain in best corrected visual acuity (BCVA).
• The light therapy stimulates retinal mitochondria, offering a non-invasive approach to improve vision loss associated with dry AMD, where existing treatments only slow disease progression.
• Data analysis showed a statistically significant difference in vision beginning at 9 months in favor of PBM (_P_ < 0.001), and a reduced risk of new-onset geographic atrophy (GA) at 24 months (_P_ = 0.007).
FDA Approves Valeda Light Delivery System for Dry Age-Related Macular Degeneration
• The FDA has approved LumiThera's Valeda Light Delivery System, marking the first therapeutic option for adult patients with dry age-related macular degeneration (AMD).
• The device uses three light-emitting diodes at different wavelengths to treat the patient's eye, improving vision by approximately one line on an eye chart after two years.
• This approval underscores the FDA's commitment to providing access to innovative and effective medical devices for treating prevalent degenerative conditions like AMD.
• The FDA, in collaboration with the EPA, also announced the registration of the first antimicrobial treatment for pathogen reduction in pre-harvest agricultural water, enhancing food safety.
FDA Approves LumiThera's Valeda Light Delivery System for Dry AMD
• The FDA granted de novo authorization to LumiThera's Valeda Light Delivery System, marking the first approved treatment for vision loss related to dry age-related macular degeneration.
• The approval was based on the LIGHTSITE III trial, which demonstrated the device's safety and efficacy in maintaining visual acuity over 24 months.
• Valeda is designed to improve best-corrected visual acuity and has shown a statistically significant reduction in conversion to geographic atrophy in intermediate AMD patients.
• LumiThera plans to make Valeda available to U.S. retina specialists, offering a new treatment option for patients with dry AMD.
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