Industry News
Clinical Trial Shows Sustained Vision Improvement in Light Delivery System for Dry AMD
LumiThera Inc., a medical device company offering photobiomodulation (PBM) treatment for ocular damage and disease, has announced the 24-month data from its LIGHTSITE III clinical trial. The study demonstrated sustained vision improvement in dry Age-Related Macular Degeneration (AMD) subjects treated with the Valeda® Light Delivery System.
The LIGHTSITE III trial, a prospective, double-masked, randomized, multi-center clinical trial, was conducted at ten leading US retinal centers and enrolled 100 subjects with early to intermediate dry AMD. The trial initially demonstrated sustained and statistically significant improvement in the primary endpoint, best corrected visual acuity (BCVA), at 13 months in the PBM treatment group when compared to the sham-treatment group.
The latest data show a sustained mean increase in ETDRS letter score >5.0 letters from baseline reported at both the 13- and 21-month time points in the PBM-treated subjects' BCVA. Additionally, the 24-month data demonstrated a significant improvement from baseline in BCVA in the PBM treatment group compared to the sham group. Approximately 58% of the PBM-treated eyes had >5 letter gain with a mean of 8.5 + 0.5 letter gain.
Moreover, the study showed a statistically significant slowing of disease progression in patients with early to intermediate dry AMD with PBM treatment. Fewer eyes progressed to new geographic atrophy (GA), a later disease stage associated with permanent loss of retinal tissue, in the PBM group.
“Previously, the LIGHTSITE III trial results demonstrated sustained improvements of visual benefits with PBM treatments out to 13 months,” stated René Rückert, MD, MBA, Chief Medical Officer, LumiThera. “The trial results confirm the multi-center European LIGHTSITE II trial and extend the improvements to two years. We have been treating patients for about 4 years in Europe and Latin America in over 9,000 estimated patients. The sustained >5 letter improvement for 24 months was outstanding considering the earlier stage of AMD disease and the good BCVA at baseline in these patients.”
“Valeda’s multi-wavelength device is an unprecedented treatment option for dry AMD patients. PBM can offer a non-invasive treatment that can improve vision and potentially address the disease earlier, before we see permanent vision loss,” stated Clark Tedford, Ph.D., President and CEO. “Reductions in the number of eyes that progress to GA were seen at the 13-month and now further extended at the 24-month timepoints.”
