LumiThera announced the 24-month data from its LIGHTSITE III multicenter clinical trial. The results showed sustained vision improvement in subjects with dry age-related macular degeneration (AMD) who were treated with the Valeda Light Delivery System.
LumiThera conducted LIGHTSITE III, a prospective, double-masked, randomized, multicenter clinical trial at ten US retinal centers. The trial enrolled 100 subjects with early to intermediate dry AMD, and the eyes were treated with the Valeda system every 4 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). LumiThera reports that there were minimal safety risks and high patient compliance, with 80% of the patients completing the trial. The PBM-treated arm showed a statistically significant improvement in visual acuity at month 21 following the last treatment, with sustained vision benefits throughout the trial, including at the 24-month trial end.
The analysis included a total of 145 eyes, with 91 eyes in the PBM treatment group and 54 eyes in the sham-treatment group, belonging to the modified intent-to-treat population, which had at least one post-treatment visit. The trial initially revealed sustained and statistically significant improvement in the primary endpoint, BCVA, at 13 months in the PBM treatment group, compared to the sham-treatment group (P=0.02).
According to LumiThera, there is now a sustained, mean increase in ETDRS letter score >5.0 letters from baseline reported at both the 13- and 21-month timepoints in the PBM-treated subjects' BCVA (P<0.0001). At the end of 24 months, the improvement from baseline in BCVA was significantly greater in the PBM treatment group than in the sham group, with 5.9 vs. 1.0 letters (P=0.0015). Approximately 58% of the PBM-treated eyes had a >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 a company news release. “The trial results confirm the multicenter European LIGHTSITE II trial and extend the improvements to 2 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.”
“The 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. 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,” stated Glenn Jaffe, MD, Duke University, Duke Reading Center. “PBM treatment showed a statistically significant (P=0.003) slowing of disease progression in patients with early to intermediate dry AMD.”