PBM treatment showed a statistically significant slowing of disease progression in patients with early to intermediate dry AMD.
LumiThera Inc. this week announced the 24-month data from its LIGHTSITE III, multi-center clinical trial which demonstrated sustained vision improvement in dry Age-Related Macular Degeneration (AMD) subjects treated with the Valeda Light Delivery System.
According to a company news release, LIGHTSITE III (NCT04065490), a prospective, double-masked, randomized, multi-center clinical trial, was conducted at 10 leading U.S. retinal centers and enrolled 100 subjects with early to intermediate dry AMD.
The company noted eyes were treated with the Valeda system every four months. The last treatment was administered at 21 months and the last follow-up visit was at 24 months. The primary efficacy endpoint was best corrected visual acuity (BCVA). At 24 months there were minimal safety risks and high patient compliance; 80% of the patients completed the trial. In 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.
The analysis included 91 eyes in the PBM treatment group and 54 eyes in the sham-treatment group in the modified intent to treat population with at least 1 post-treatment visit. The trial initially demonstrated sustained and statistically significant improvement in the primary endpoint, BCVA, at 13 months in the PBM treatment group when compared to the sham-treatment group (p = 0.02). Now, a sustained, mean increase in ETDRS letter score >5.0 letters from baseline is reported at both the 13- and 21-month timepoints in the PBM-treated subjects BCVA (p < 0.0001).
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). Approximately 58% of the PBM-treated eyes had >5 letter gain with a mean of 8.5 + 0.5 letter gain.
“Previously, the LIGHTSITE III trial results demonstrated sustained improvements of visual benefits with PBM treatments out to 13 months,” René Rückert, MD, MBA, chief medical officer, LumiThera, said in the news release. “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.”
Rückert added 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.
According to Glenn Jaffe, MD, Duke University, Duke Reading Center, patients further underwent a detailed retinal morphology analysis using optical coherence tomography (OCT) during the course of the trial.
“Fewer eyes progressed to new geographic atrophy (GA), a later disease stage that is associated with permanent loss of retinal tissue,” he said om the news release. “The 24-month OCT data indicated that 5 of 88 eyes (5.7%) in the PBM group had progressed to new GA, whereas 11 of 51 eyes (21.6%) in the sham arm developed new GA.”
Jaffe noted the PBM treatment showed a statistically significant (p = 0.003) slowing of disease progression in patients with early to intermediate dry AMD.”
“These final results from the LIGHTSITE III trial are indeed very exciting and encouraging,” said Diana V. Do, MD and Quan Dong Nguyen, MD, MSc. Both are 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. “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.”
Clark Tedford, PhD, LumiThera’s president and CEO, pointed out in the news release that 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,” Tedford said in the news release. “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.”
Effect on geographic atrophy
Photobiomodulation has had a positive effect on the appearance of atrophic lesions, as new geographic atrophy developed in approximately 10% of the sham-treated eyes compared with 1.1% of the active-treatment eyes. This difference reached significance (P = .025) in the patients with intermediate dry AMD.