LIGHTSITE 3B Shows Long-Term Vision Gains in Dry AMD

LumiThera has announced promising results from its LIGHTSITE 3B extension trial, highlighting continued visual acuity improvements in patients with dry age-related macular degeneration (AMD). The study builds on earlier findings from the pivotal LIGHTSITE 3 trial and provides further evidence supporting the long-term efficacy and safety of the Valeda Light Delivery System—the first FDA-authorized treatment aimed at improving vision in dry AMD.

LIGHTSITE 3B Extension Trial Overview

The LIGHTSITE 3B extension trial is a prospective, open-label study designed to evaluate the long-term benefits of Valeda in patients with dry AMD. Participants from the original LIGHTSITE 3 pivotal trial were enrolled for an additional 13-month treatment cycle using the Valeda Light Delivery System. Notably, this follow-up trial took place after a 20-month treatment hiatus, allowing for an assessment of sustained and renewed visual improvement upon retreatment.

FDA Approval and Valeda’s Clinical Significance

Valeda received FDA authorization in November 2024, becoming the first approved treatment aimed at improving vision in patients with dry AMD. During the LIGHTSITE 3 trial, the system achieved its primary endpoint by demonstrating safety and efficacy, with participants showing an average improvement in best corrected visual acuity (BCVA) of over five letters—equivalent to one line on a standard eye chart—over a 24-month period.

Extension Trial Results: Sustained Vision Benefits

According to Dr. David Boyer, MD, FASRS, from Retina Vitreous Associates Medical Group in Beverly Hills, California, “The LIGHTSITE 3B extension trial results extend 2-year pivotal trial vision benefits out to 4.5 years and showed an excellent safety profile.” He emphasized the significance of maintaining visual gains during the 20-month no-treatment period between trials and further vision recovery upon retreatment.

Clinical Data Presented at ARVO 2025

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

Dr. Quan Dong Nguyen remarked, “The primary endpoint of the trial was BCVA gain. After another 13 months of treatment, although the study population of LIGHTSITE 3B is relatively small, more than 60% of the subjects treated in both trials continued to show a vision improvement of over one line.” He added, “This is the first and only FDA-authorized treatment that can improve vision with benefits extending out to 4.5 years, underscoring the potential of earlier and sustained treatment for optimal outcomes.”

Implications for Dry AMD Treatment

Clark Tedford, PhD, President and CEO of LumiThera, stated, “There is now a non-invasive treatment for dry AMD patients that can improve vision and address the disease earlier, before permanent vision loss.” He highlighted the long-term significance of the extension trial, noting that Valeda may be altering the trajectory of vision loss and delivering sustainable improvements over several years with ongoing therapy.