LumiThera has secured CE mark approval for its Valeda Light Delivery System in 2018 for the treatment of dry AMD
LumiThera, a commercial stage medical device company, has partnered with Diopsys to conduct a human clinical trial to treat dry Age-related Macular Degeneration (AMD) patients.
Under the partnership, the companies will jointly conduct the trial of Photobiomodulation (PBM) treatment using the Valeda Light Delivery System to improve Electroretinogram (ERG) outcomes in the US subjects diagnosed with dry AMD.
LumiThera has secured CE mark approval for its Valeda Light Delivery System in 2018, for the treatment of dry AMD, and is currently is investigating the system to treat dry AMD and Diabetic Retinopathy patients in clinical trials.
Diopsys CEO Joe Fontanetta said: “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.
“This study will further establish ERG as the diagnostic tool for novel treatments such as PBM.”
LumiThera study will focus on multi-focal ERG function changes
The clinical trial study will be conducted by researchers Dan Montzka and Larry Perich at the Perich Eye Centre in New Port Richey, Florida, US.
In the clinical trial, subjects will receive three PBM treatments once-a-week, for a total of nine sessions over three weeks, and will be followed for up to six months.
The primary analysis of the study will focus on multi-focal ERG function changes.
LumiThera is engaged in developing a photobiomodulation (PBM) treatment to address ocular disorders and diseases.
Recently, the company has received a small business innovative research (SBIR) phase II grant from the National Institute of Health (NIH) and the division of the National Eye Institute (NEI).
LumiThera president and CEO Clark E Tedford said: “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.
“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.”