Valeda light delivery system provides sustained visual acuity improvements in dry AMD
Click Here to Manage Email Alerts
CHICAGO — Patients with dry age-related macular degeneration experienced sustained improvements in best correct visual acuity at month 13 of the LIGHTSITE III pivotal clinical trial, according to a study presented at Eyecelerator@AAO.
Clark E. Tedford, PhD, president and CEO of LumiThera, said the Valeda light delivery system uses a multiple wavelength approach with LEDs to provide a short treatment to stimulate mitochondrial markers.
“We do nine sessions over the course of about 3 to 4 weeks,” he said. “It takes a little over 4 minutes per eye, and we can do both eyes back to back.”
The trial involved 148 eyes of 100 patients with dry AMD across 10 centers in the United States who were randomly assigned to undergo treatment with photobiomodulation (PBM) or sham.
At month 13, patients in the PBM group had better BCVA letter score compared with those in the sham group (P = .02). Additionally, the PBM group had sustained and improved BCVA with a mean 5.5 letter change from baseline at month 13 (P < .0001).
Tedford said 55% of eyes in the PBM group responded with a gain of at least 5 letters, 26.4% responded with a gain of at least 10 letters, and 5.5% responded with a gain of at least 15 letters. Additionally, he said the study showed a good safety profile with no signs of phototoxicity.
“We’ll continue to follow the study out to 24 months, and that should be coming in the first quarter of next year,” Tedford said.
Collapse
Tedford CE. LIGHTSITE III: 13-month U.S. pivotal clinical trial results. Presented at: Eyecelerator@AAO; Sept. 29, 2022; Chicago.
Read more about
Click Here to Manage Email Alerts