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March 23, 2022
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Interim trial results show efficacy of photobiomodulation in dry AMD

LumiThera reported positive findings in the LIGHTSITE III clinical trial evaluating the safety and efficacy of photobiomodulation with the Valeda light delivery system as a treatment for dry age-related macular degeneration.

One hundred patients were enrolled at 10 centers in the U.S. and randomly assigned to receive photobiomodulation (PBM) treatment or sham every 4 months for 2 years. The interim results were evaluated at 13 months and were found to be “very encouraging,” according to a company press release.

PBM uses a multi-wavelength approach to stimulate cellular function, leading to improved energy production within the mitochondria, according to the company website. It is delivered using the Valeda light delivery system during short sessions of less than 5 minutes per eye. In the LIGHTSITE III study, statistically significant improvement in best corrected visual acuity was achieved at 13 months in the PBM treatment group over the sham treatment group, with a sustained increase of 5.5 ETDRS letters from baseline. These findings confirmed the positive outcomes of the previous LIGHTSITE II European study.

At the time of enrollment in the trial, patients had dry AMD for a mean of 4.9 years.

“Consideration should be given to the application of PBM earlier in the degenerative disease process and prior to permanent retinal tissue and vision loss to demonstrate if PBM may prevent or slow degenerative eye disease,” Clark Tedford, PhD, president and CEO of LumiThera, said in the release.

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