LumiThera Inc., a commercial stage medical device company creating a photobiomodulation (PBM) treatment for ocular disorders and disease, announced it is collaborating with Diopsys, a leading provider of modern visual electrophysiology solutions. Diopsys’ technology helps eye care professionals accurately and objectively measure retinal and visual pathway function.
The joint effort supports 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 your central vision can make it harder 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 central vision loss in one eye or both eyes.
“ERG produces objective, functional results in visual outcomes and enables improved patient management,” stated 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,” indicated 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.
Diopsys, Inc. is the world leader in modern visual electrophysiology medical devices that help eye care professionals analyze the entire visual pathway for visual and neuro-visual disorders. The company provides both Visual Evoked Potential (VEP) and Electroretinography (ERG) vision testing technology. It is this technology that powers Diopsys, Inc.’s medical devices – the Diopsys® NOVA™, Diopsys® ARGOS™, and Diopsys® RETINA PLUS™ ERG and VEP Vision Testing System product series and the Enfant® Pediatric VEP Vision Testing System.
About LumiThera Inc.
LumiThera is a commercial-stage medical device company focused on treating people affected by ocular disorders and diseases including dry age-related macular degeneration, a leading cause of blindness in adults over 65. The company is a leader in the use of PBM for treatment of acute and chronic ocular diseases and disorders. The company is developing the office-based Valeda® Light Delivery System to be used by eye care specialists as medical treatments.
The Valeda Light Delivery System has been granted authorization to use the CE Mark by an EU Notified Body as required for commercial use in the European Union only. Valeda is not approved for use by the Food & Drug Administration (FDA) in the USA.