Medical device company LumiThera Inc. said data from its LIGHTSITE III clinical trial demonstrated sustained vision improvement in early and intermediate age-related macular degeneration (AMD) subjects treated with the Valeda Light Delivery System.
“Reductions in the number of eyes that progress to (late stage geographic atrophy) were seen at the 13-month and now further extended at the 24-month timepoints,” LumiThera said in a company news release.1
LIGHTSITE III, a prospective, double-masked, randomised, multi-centre clinical trial, was conducted at 10 retinal centres in the US, and enrolled 100 subjects with early to intermediate AMD.
Eyes were treated with the Valeda system, which uses multiwavelength photobiomodulation (PBM) to treat early and intermediate AMD patients, 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.
The trial results confirm the multi-centre European LIGHTSITE II trial and extend the improvements to two years.
Statistically significant improvement
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.
“Previously, the LIGHTSITE III trial results demonstrated sustained improvements of visual benefits with PBM treatments out to 13 months,” stated Dr René Rückert, Chief Medical Officer, LumiThera.
“The trial results confirm the multi-centre European LIGHTSITE II trial and extend the improvements to two years. We have been treating patients for about four 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,” Dr René Rückert said.
LumiThera President and CEO Dr Clark Tedford said Valeda 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.”
Valeda is CE Marked in the European Union and is available in Europe and in countries in Latin America. Valeda is not yet approved by the United States Food & Drug Administration.
Reference
- LumiThera Inc., LumiThera Announces Sustained Vision Improvement for 24 months in Dry Age-Related Macular Degeneration Subjects from US LIGHTSITE III Clinical Trial Data (media release) 15 March 2023, available at www.businesswire.com/news/home/20230315005170/en/LumiThera-Announces-Sustained-Vision-Improvement-for-24-months-in-Dry-Age-Related-Macular-Degeneration-Subjects-from-US-LIGHTSITE-III-Clinical-Trial-Data (accessed 21 March 2023).
