LumiThera’s LIGHTSITE Phase 3B Extension Trial Shows Extended Vision Improvement in Dry AMD

LumiThera announced the topline results from the LIGHTSITE 3B extension trial, a prospective, open-label trial in dry age-related macular degeneration (AMD) subjects. The extension trial followed subjects that completed the pivotal LIGHTSITE 3 trial and resumed treatment for 13 months with the Valeda Light Delivery System. 

Approved in November 2024, Valeda is the first FDA-authorized treatment to improve vision in dry AMD patients. In the LIGHTSITE 3 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 1 line improvement on the eye chart.

“The LIGHTSITE 3B extension trial results extend 2-year pivotal trial vision benefits out to 4.5 years and showed an excellent safety profile,” David Boyer, MD, FASRS, Retina Vitreous Associates Medical Group, Beverly Hills, California, said in a company news release. “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 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 primary endpoint of the trial was BCVA gain. After another 13 months of treatment, although the size of the study population of LIGHTSITE 3B 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,” said 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, PhD, 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.”