FDA Grants Breakthrough Designation For Device To Treat Parkinson’s

This device has been designed to be used at home, explains Kent Savage who is the CEO of the company; the website and press release suggests that this is the first of such devices to receive the priority designation that the FDA reserves for novel devices that are trying to fulfill an outstanding patient need. 

“Our specialized phototherapy device is a prescription device intended as an adjunct therapy for the treatment of Parkinson’s disease and is intended to be used concurrently with standard dopaminergic therapy and is designed primarily for home use,” Savage said. “It is a table-top, therapeutic light source similar to a tablet, which generates soft blend of specific wavelengths of light that gently bathe the user’s face while they enjoy other activities such as watching TV, eating, reading or spending time online. Most enjoy the light each evening for an hour.”

The exact mechanism of action behind Spectramax Light Therapy is still unknown, but a phase 2 trial showed that adding the light therapy helped to improve the motor and non-motor functions as well as the overall quality of life of those with Parkinson’s disease who were enrolled in the study. It is believed that the benefits may likely be due to the specialized photo-therapy helping to restore circadian functions that regulate physical, mental, and behavioral functions. 

JAMA Neurology Journal published a study that was featured on Parkinson’sDisease.net that showed “light therapy significantly reduced daytime sleepiness, improved sleep quality, decreased overnight awakenings, improved daytime alertness and activity level, and improved motor symptoms in people with Parkinson’s.” But this study was largely based on near infrared light, and as Savage explains near infrared light has been used in animal models and requires surgery. 

This is not the only company working to develop light therapy devices for use in depressive disorders ranging to treat behavioral symptoms that are associated with Alzheimer’s disease among others. “The most common light therapy solution on the market is ocular bright light therapy used in neuropsychiatric disorders. Unfortunately, the wavelengths and intensities of light from bright light therapy are inappropriate for PD patients,” Savage said. 

Currently there is no cure for Parkinson’s disease. The company is currently engaged in seeking financing to support a clinical trial of their Celeste Phototherapy device based on its Spectramax technology. The proposed Phase 3 trial is expected to enroll up to 200 patients in August 2020, any interested in more information can visit their website.