LumiThera announced 24-month data from its multi-centre clinical trial of the Valeda Light Delivery System demonstrated sustained vision improvement in dry age-related macular degeneration (AMD) patients.
The LIGHTSITE III trial’s 100 subjects with early to intermediate dry AMD were treated with the non-invasive Valeda photobiomodulation (PBM) system every four months. The PBM-treated arm showed 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, according to a LumiThera statement.
Previous trial results demonstrated sustained improvements of visual benefits with PBM treatment out to 13 months, said Dr René Rückert, LumiThera’s chief medical officer. “These 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 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.”
Dr Glenn Jaffe, Duke University, also noted 24-month OCT data showed just five of 88 eyes (5.7%) in the PBM group progressed to new geographic atrophy (GA), compared to 11 of 51 eyes (21.6%) in the sham arm.
“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,” said Dr Diana Do, professor of ophthalmology at Stanford University, a clinical site for the LIGHTSITE III trial.
