LumiThera’s LIGHTSITE IIIB Extension Trial Topline Results Show Extended Vision Improvement in Dry AMD Subjects

LumiThera Inc., a medical device company offering photobiomodulation (PBM) treatment for ocular damage and disease, today announced the topline results from the LIGHTSITE IIIB Extension Trial, a prospective, open-label trial in dry (non-neovascular) age-related macular degeneration (AMD) subjects. The extension trial followed subjects that 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 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 >5 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, MD, FASRS, Retina Vitreous Associates Medical Group, Beverly Hills, CA. “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.”

The trial results were presented on May 7^th at the 2025 Meeting of the Association for Research in Vision and Ophthalmology 2025 (ARVO) by co-investigators Diane Do, MD, FASRS and Quan Dong Nguyen, MD, MSc, FARVO, FASRS, Byers Eye Institute, Stanford University.

The ARVO Annual Meeting is the premiere gathering for eye and vision scientists from across the globe, at all career stages, students, and those in affiliated fields to share the latest research findings and collaborate on innovative solutions and was held May 4 - 8inSalt Lake City, Utah.

“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, MD. MSc, FARVO, FASRS, Professor of Ophthalmology, Medicine, and Pediatrics at the 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,” stated Clark Tedford, Ph.D., President and CEO, LumiThera, Inc. “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.”

About AMD

AMD is a leading cause of vision loss for people aged 65 and older. Losing central vision can make it harder to see faces, drive, or do close-up work like cooking or fixing things around the house. The overall prevalence of AMD is estimated to increase 7-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).

About LumiThera

LumiThera, Inc. is an ophthalmic medical device company that is Harnessing the Power of Light^™ to offer a comprehensive approach for detecting, treating, and monitoring retinal diseases, specifically dry AMD.

LumiThera is the leader in ophthalmic PBM innovation with its flagship product, the Valeda^® Light Delivery System. Multiwavelength Valeda treatments are for patients suffering from dry AMD. The Food & Drug Administration (FDA) has authorized marketing of Valeda treatment for dry AMD patients to improve vision. Valeda is CE Marked in the EU, UKCA Marked in the UK, and is available in select countries in Latin America.

AdaptDx Pro® is a portable dark adaptometer that utilizes artificial intelligence to deliver a uniform patient experience. Impaired dark adaptation speed indicates rod-mediated dysfunction, one of the first functional signs of retinal disease. AdaptDx Pro is available in the U.S. and Canada.

NOVA Vision Testing System is a comprehensive electrophysiology platform that provides objective assessment of the entire pathway for visual and neuro-visual disorders. Visual evoked potential is available in the U.S. and select countries outside of the U.S. Electroretinography is only available outside of the U.S.

For more information on Valeda, visit www.lumithera.com. AdaptDx Pro and NOVA are available through LumiThera Diagnostics, Inc. and Diopsys, Inc., respectively.

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