LumiThera, Diopsys Enrolls of First Subject in Dry AMD ELECTROLIGHT Study

LumiThera is collaborating with Diopsys to support a prospective, pilot, human clinical trial in U.S. subjects diagnosed with dry Age-related Macular Degeneration. The study will be conducted by Dan Montzka, M.D. and Larry Perich, D.O. at the Perich Eye Center, New Port Richey, Florida. The study will evaluate the ability of Photobiomodulation (PBM) treatment using the Valeda® Light Delivery System to improve Electroretinogram (ERG) outcomes in subjects with dry Age-related Macular Degeneration (AMD). Subjects will be followed for up to six months. Subjects will receive three PBM treatments per week for three weeks for a total of nine sessions over three weeks. The primary analysis will examine multi-focal ERG function changes.

AMD is a leading cause of vision loss for people age 50 and older. It destroys the macula, the part of the eye that provides sharp, central vision needed for seeing objects clearly. Losing central vision can make it harder to see faces, drive, or do close-up work like cooking or fixing things around the house.  If a patient has early AMD, vision loss may not occur for a long time. For other people, AMD progresses faster and can lead to central vision loss in one eye or both eyes.

"ERG produces objective, functional results in visual outcomes and enables improved patient management," said Larry Perich, D.O., Faculty, HCA/USF Ophthalmology residency program. "ERG testing can help doctors manage many common disorders like dry AMD, glaucoma, diabetic retinopathy, and other indications. ERG outcomes combined with PBM treatment could identify patient improvements, monitor progress and optimize retreatment."

“We are excited to work with LumiThera and the goal is to use ERG testing as a diagnostic monitoring test to work with LumiThera's PBM treatments to further characterize patient benefits on visual function," said Joe Fontanetta, CEO, Diopsys. "This study will further establish ERG as the diagnostic tool for novel treatments such as PBM."

"PBM shows improvements in ERG functional testing in animal studies and is a gold-standard for visual function, and ERG testing can be used very early in the disease stage to identify visual disturbances," stated Clark E. Tedford, Ph.D., President and CEO, LumiThera, Inc. "As we bring forward the PBM platform for ocular disease and disorders, we want to couple PBM treatments with diagnostic and imaging modalities to help doctors diagnose, monitor and treat patients early and effectively. This study will allow us to examine ERG changes over time and set the foundation for treatment practices.

In 2018, LumiThera obtained a CE mark to commercialize the Valeda Light Delivery System in Europe for the treatment of dry AMD. Currently LumiThera is investigating the benefits of the Valeda Light Delivery System in dry AMD and Diabetic Retinopathy patient clinical trials.