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- Alcon announced the acquisition of LumiThera, Inc. and its photobiomodulation device for treating early and intermediate dry age-related macular degeneration, expanding beyond its traditional surgical focus. - LumiThera's Valeda Light Delivery System is the only approved technology demonstrating consistent visual improvement over 2 years in dry AMD patients, using non-invasive light therapy to stimulate retinal cellular health. - Clinical trial data from LIGHTSITE III showed patients gained one line of visual acuity from baseline and 88% maintained or gained vision at 24 months, with no treatment-related serious adverse events. - The acquisition, expected to close in Q3 2025, positions Alcon to address significant unmet medical needs in dry AMD treatment through non-invasive photobiomodulation therapy.
- 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, 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.
- 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).
- The FDA has granted marketing authorization to LumiThera's Valeda Light Delivery System, marking the first authorized treatment for vision loss in dry age-related macular degeneration (AMD). - Clinical data from the LIGHTSITE III trial demonstrated that Valeda significantly improved best-corrected visual acuity (BCVA) in dry AMD patients over 24 months. - The LIGHTSITE III trial showed a sustained, statistically significant improvement in BCVA at 13 and 21 months in the PBM treatment group compared to the sham group. - Anatomical endpoints suggest that photobiomodulation (PBM) may help preserve retinal anatomy and reduce the progression to geographic atrophy in dry AMD patients.
- 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.
- 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.
- LumiThera's Valeda Light Delivery System has been authorized by the FDA for treating vision loss in patients with dry age-related macular degeneration (AMD). - The authorization is based on the LIGHTSITE III trial, which demonstrated that Valeda improves best corrected visual acuity (BCVA) by over 5 letters after 24 months. - Valeda is the first FDA-authorized treatment for vision loss in dry AMD patients, offering a non-invasive option to improve vision early in the disease process. - The LIGHTSITE III trial also showed that Valeda treatment had a beneficial effect on multiple anatomic biomarkers, reducing the progression to geographic atrophy.
