FDA grants breakthrough designation to a light device for the treatment of Parkinson’s
The Food and Drug Administration recently awarded a breakthrough device designation for a phototherapy device intended to help patients with Parkinson’s Disease.
The non-invasive device is made by American Fork, Utah-based PhotoPharmics and is meant to be used at home, explained Kent Savage, CEO of PhotoPharmics, in an email response. The company’s website and press release claims that this is the first specialized light therapy device to receive such a priority designation for the FDA reserved for novel devices trying to fulfill an unmet 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 prescription light therapy device aims to treat patients with Parkinson’sWhile the mechanism of action is unknown, a phase 2 trial conducted by the company showed that adding light therapy improved the motor and non-motor functions as well as the overall quality of life in patients suffering from Parkinson’s. Savage believes this is likely because specialized phototherapy helps to restore circadian function. Circadian rhythms regulate physical, mental and behavioral functions.
According to Parkinson’sDisesae.Net, research published in the February 2017 JAMA Neurology Journal, showed that “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.”
However, this was mostly based on near-infrared light but Savage explained that near infrared light has been used in animal models and requires surgery.
PhotoPharmics has raised $11 million in a seed and Series A round from angel investors and others including Kickstart Seed Fund and Upstart Ventures. Savage is hoping to raise another $10 million in a Series B round currently underway.
There are other companies that are developing light therapy for depressive disorders or to treat certain behavioral symptoms associated with Alzheimer’s Disease.
“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.