LumiThera Shares Encouraging LIGHTSITE IIIB Extension Study Results

LumiThera Inc.’s Valeda Light Delivery System is a safe, effective treatment for dry age-related macular degeneration, study data demonstrate.

The topline results are derived from the LIGHTSITE IIIB Extension Trial, a prospective, open-label study that followed dry (non-neovascular) age-related macular degeneration (AMD) patients who completed the pivotal LIGHTSITE III trial and resumed treatment for 13 months with the Valeda Light Delivery System. Dry AMD is a leading cause of central vision loss in people over 55 in developed countries.

Valeda is the first U.S. Food and Drug Administration (FDA)-authorized treatment (November, 2024) to improve vision in dry AMD patients. In the pivotal U.S. LIGHTSITE III trial, Valeda met the primary endpoint and was shown to be safe and effective. Valeda demonstrated an improvement in best corrected visual acuity (BCVA) for 24 months of more than five letters or equivalent to one line improvement on the eye chart.

“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, M.D., of Retina Vitreous Associates Medical Group in Beverly Hills, Calif. “This is very exciting data for early to intermediate dry AMD patients. The 4.5-year follow-up included a 20-month no-treatment period between the two trials, wherein the patients still maintained some vision benefit from the earlier pivotal trial and recovered vision upon retreatment in the extension trial.”

AMD is a leading cause of vision loss for people aged 65 and older. Losing central vision can make it more difficult to see faces, drive, or do close-up work like cooking or making house repairs. The overall prevalence of AMD is estimated to increase seven-fold 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).

“The primary endpoint of the trial was BCVA gain. After another 13 months of treatment, although the size of the study population of LIGHTSITE IIIB is relatively small, >60% of the subjects that received Valeda treatment in both studies were still showing a benefit in vision of over one line,” indicated Quan Dong Nguyen, M.D., professor of Ophthalmology, Medicine, and Pediatrics at Stanford University School of Medicine. “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.”

“There is now a non-invasive treatment for dry AMD patients that can improve vision and address the disease earlier, before permanent vision loss,” LumiThera President/CEO Clark Tedford, Ph.D. stated. “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.”

LumiThera, Inc. is an ophthalmic medical device company that harnesses the power of light to offer a comprehensive approach for detecting, treating, and monitoring retinal diseases, specifically dry AMD. LumiThera’s flagship product, the Valeda Light Delivery System is specifically for patients suffering from dry AMD. The FDA has authorized Valeda treatment marketing for dry AMD patients; Valeda is CE Marked in the EU, UKCA marked in the United Kingdom, and is available in select Latin American countries.

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