A US company, LumiThera Inc., based in Seattle, WA has reported summary trial data on photo-biomodulation, termed “LIGHTSITE III” study, conducted by a multi-centre clinical trial in dry age-related macular degeneration (AMD). The photo-biomodulation (PBM) device is aimed to activate mitochondrial respiratory chain components resulting “in stabilization of metabolic function and initiation of a signalling cascade, which promotes cellular proliferation and cytoprotection”, according to the company. The medical device (termed as their Valeda Light Delivery System) has developed a CE mark to use wavelengths of light in the far red to near infrared spectrum (590, 660 and 850 nm) to modulate biologic function through direct and indirect cellular effects on mitochondrial respiratory chain components. PBM activation “of photo-acceptors in the mitochondria improves generation of adenosine triphosphate (ATP), modulates the production of intracellular signalling molecules such as reactive-oxygen species (ROS) and nitric oxide (NO), and triggers secondary effects that produce sustained changes in cell function and viability”.
A prospective, double-masked, randomized, multi-centre clinical trial (clinicaltrils.gov, NCT04065490), reported that 100 subjects with early to intermediate dry AMD were enrolled in the study. The Valeda system was administered every four months, at 21 months, and with the last follow-up visit at 24 months. The primary efficacy endpoint was BCVA and the PBM-treated arm, there was a statistically significant visual acuity improvement at month 21 “following the last treatment with sustained vision benefits throughout the trial including the 24-month trial end”. In addition, the company reported minimal safety risks and high patient compliance at 24 months and 80% of the patients completed the trial. According to the analysis, there was 91 eyes in the PBM treatment group and 54 eyes in the sham-treatment group “in a modified intent to treat population with at least 1 post-treatment visit”. The improvement from baseline in BCVA at 24 months in the PBM treatment group was significantly greater than in the sham group, 5.9 vs 1.0 letters (p = 0.0015) (under the modified intent to treat). The company reported that approximately 58% of the PBM-treated eyes had >5 letter gain with a mean of 8.5 + 0.5 letter gain.
Commenting on the summary results, Diana V. Do, MD and Quan Dong Nguyen, MD, MSc, both professors of ophthalmology and members of the Retina Division at the Byers Eye Institute at Stanford University, which is one of the clinical sites for the LIGHTSITE III trial, stated that “these final results from the LIGHTSITE III trial are indeed very exciting and encouraging. PBM is a non-invasive therapy that can improve and sustain vision and slow the progression of disease. PBM is a significant advancement in saving sight for AMD patients. We are in urgent need of therapy for our patients with dry AMD, especially if the treatment is non-invasive such as the Valeda Light Delivery System.”