Friday, September 11, 2020
LumiThera Inc., a commercial medical device company creating a photobiomodulation (PBM) treatment for eye diseases and disorders, announced that it is collaborating with Diopsys, a provider leader in modern visual electrophysiology solutions. Diopsys technology helps eye care professionals accurately and objectively measure the function of the visual pathway and the retina.
The joint effort supports a pilot, prospective human clinical trial in American subjects diagnosed with dry age-related macular degeneration. The study will be conducted by Dan Montzka , MD and Larry Perich , DO 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) results in subjects with dry age-related macular degeneration (AMD). Subjects will be followed 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 main analysis will examine changes in multifocal ERG function.
AMD is one of the leading causes of vision loss for people 50 and older. It destroys the macula, the part of the eye that provides sharp, central vision necessary to see objects clearly. Losing central vision can make it difficult to see faces, drive, or do close-up work like cooking or fixing things around the house. If you have early AMD, you may not experience vision loss for a long time. For other people, AMD progresses faster and can lead to loss of central vision in one or both eyes.
"ERG produces objective and functional results in visual outcomes and enables improved patient management," stated Larry Perich , DO, College, HCA / USF ophthalmology residency program. "ERG testing can help clinicians manage many common disorders such as dry AMD, glaucoma, diabetic retinopathy, and other indications. ERG results combined with PBM treatment could identify patient improvements, monitor progress, and optimize the retreat. "
We are delighted to be working with LumiThera and the goal is to use ERG testing as a diagnostic control test to work with LumiThera's PBM treatments to further characterize patient benefits in visual function, "said Joe Fontanetta , CEO of Diopsys. "This study will further establish ERG as the diagnostic tool for new treatments like 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," said Clark E. . Tedford , Ph.D., President and CEO, LumiThera, Inc. "" As we advance the PBM platform for eye diseases and disorders, we want to couple PBM treatments with diagnostic and imaging modalities to help clinicians diagnose, monitor and treat patients early and effectively. This study will allow us to examine ERG changes over time and lay the foundation for treatment practices.
In 2018, LumiThera obtained a CE mark to market the Valeda Light Delivery System in Europe for the treatment of dry AMD. LumiThera is currently investigating the benefits of the Valeda Light Delivery System in clinical trials of patients with dry AMD and diabetic retinopathy.