100 patients enrolled in trial of light therapy for Parkinson’s disease
Home-based device designed for use one hour a day
Photopharmics said the first 100 patients have been enrolled in a Phase 3 trial testing its light-based therapy device, Celeste, to treat Parkinson’s disease.
The Light for PD trial, which is expected to enroll 300 patients, is evaluating the device’s safety and efficacy at easing both motor and non-motor symptoms of Parkinson’s and improving patients’ quality of life.
During the trial, patients will use the device at home once daily for an hour during their normal evening activities, like reading, watching TV, or eating, while their current medication regimens remain unchanged.
“We are thrilled to reach this important milestone,” Kent Savage, president and CEO of Photopharmics, said in a company press release. “We believe our passive and non-invasive specialized phototherapy device will provide substantial benefits to those affected by this debilitating disease.”
Besides motor symptoms such as tremors, muscle rigidity, and slowness of movements, Parkinson’s patients also experience non-motor symptoms, including emotional or mood changes, cognitive impairment, sleep problems, and fatigue. These symptoms have been associated with poor regulation of circadian rhythm, the natural mechanism that regulates essential functions such as sleep, rest-activity patterns, or metabolism.
Targeting circadian rhythm receptors
PhotoPharmics’ phototherapy device uses specific light intensities and bandwidths targeting the photoreceptors — light-sensitive receptors in the back of the eye — involved in the regulation of the circadian rhythm. In preclinical studies, light therapy was suggested to improve circadian rhythm and ease disease symptoms.
“We are committed to advancing the application of specialized phototherapy for neurodegenerative diseases,” said Dan Adams, Photopharmics’ chief medical officer. “Our focus is understanding the impact of retinal deterioration in these diseases and developing non-invasive treatment options to improve quality of life and potentially slow disease progression.”
In a previous clinical trial (NCT02175472) sponsored by the company, the therapy’s efficacy was assessed in 92 patients, ages 45 and older, under stable dopamine replacement therapy for at least a month.
The therapy was generally well tolerated and reduced disease severity, eased nonmotor symptoms, and improved patients’ quality of life, compared with patients using a similar device providing light without a therapeutic effect.
The Light for PD trial, developed together with the Center for Health + Technology at the University of Rochester Medical Center, will evaluate the treatment’s efficacy in a telemedicine format, which is designed to make the therapy more convenient and accessible to a broader range of patients.
The trial’s main goals include improvements in overall quality of life, motor function, sleep quality, mood, and cognition, as measured through clinical scales and patient-reported outcomes, after six months of treatment.
“This study leverages cutting-edge phototherapy to potentially improve motor and nonmotor symptoms, offering new hope to patients,” said Ray Dorsey, MD, professor of neurology at the University of Rochester and lead investigator for the trial. Dorsey said the collaboration and the trial participants’ “dedication” point to “the importance of advancing research to find effective solutions for neurodegenerative diseases.”
The U.S. Food and Drug Administration (FDA) has designated Celeste phototherapy as a breakthrough device, a status given to medical devices aiming to provide more effective treatment for life-threatening or debilitating conditions. The company is exploring the technology for other neurodegenerative diseases, such as Alzheimer’s disease and Huntington’s disease.
“Our goal is to bring safe, effective, and innovative treatments to patients in need, enhancing their quality of life and providing new hope in the management of neurodegenerative diseases,” Savage said.
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