LumiThera Inc. 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 who completed the pivotal LIGHTSITE III trial and resumed treatment for 13 months with the Valeda Light Delivery System, the company said in a press release. 

According to LumiThera Inc., Valeda is the first FDA-authorized treatment (November, 2024) to improve vision in dry AMD patients. In the pivotal US 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 1 line improvement on the eye chart.

“The LIGHTSITE IIIB Extension Trial results extend 2-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, California, in the press 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 2 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 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 Dr. Nguyen, in the press release. “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.”

Clark Tedford, PhD, president and CEO, LumiThera, Inc., added: “There is now a non-invasive treatment for dry AMD patients that can improve vision and address the disease earlier, before permanent vision loss. 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.”