Developer launches long-awaited study of light device for Parkinson’s

An oversized red pen checks off boxes marked "Clinical" and "Trials" on a clipboard checklist.

After years of delays, medical device company Photopharmics has started a pivotal clinical trial to test its Celeste device, a noninvasive treatment tool that aims to use light to manage the symptoms of Parkinson’s disease.

The long-awaited trial has been in the works since 2020, shortly after the light-based therapy was granted breakthrough device designation by the U.S. Food and Drug Administration (FDA).

“After overcoming funding challenges and delays caused by the global pandemic, we are thrilled to launch this trial, which holds immense promise for those affected by Parkinson’s disease,” Kent Savage, president and CEO of Photopharmics, said in a company press release.

The study is being run as a collaboration between Photopharmics and the Center for Health and Technology at the University of Rochester Medical Center (URMC), in New York. Additional information, including a form patients can use to determine if they’re eligible to participate in the study, is available at the trial’s website, lightforpd.com.

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The Celeste device was developed based on the finding that Parkinson’s frequently causes damage to cells in the retina, the part of the eye that senses light. The research showed that patients often experience abnormalities in circadian rhythms — the day-by-day biological cycles that help control bodily processes like hunger and sleep.

The device, which is noninvasive, uses light-based therapy, called phototherapy, to activate specific receptors in the eye that help regulate circadian rhythms. In doing so, the light device aims to help ease Parkinson’s symptoms that are associated with circadian rhythm abnormalities, such as sleep problems, fatigue, and depression.

Dan Adams, Photopharmics’ chief science officer, said the device “demonstrated remarkable improvements in both quality of life and non-motor symptoms for [Parkinson’s] patients” in early clinical studies.

Adams added that Celeste promises to be “a new horizon in [Parkinson’s] treatment.”

According to Adams, a pivotal trial for a medical device is similar to a Phase 3 clinical trial for a medication — it’s a large study designed to test the effectiveness of the treatment. He said that Photopharmics has already presented the trial’s design to the FDA, which gave it a “favorable review.”

The trial’s design was to be shared with scientists and medical professionals last year at the World Parkinson Congress, which the company hoped would allow for collaboration with researchers.

[The device] demonstrated remarkable improvements in both quality of life and non-motor symptoms for [Parkinson’s] patients.

The pivotal study is expected to enroll about 300 people with Parkinson’s who are experiencing notable symptoms despite standard-of-care therapy.

According to Photopharmics, such recruitment would make it the largest study of a phototherapy intervention in Parkinson’s to date. Participants in the trial will incorporate the use of the Celeste light device into their evening routines, while also continuing to receive standard-of-care treatments.

The trial will use a telemedicine approach wherein patients can undergo assessments from home. That would help make participation easier for patients, especially those who don’t live near specialty medical centers.

“The convenience of assessing patients’ progress at home makes this trial particularly relevant and accessible,” said Ray Dorsey, MD, a professor of neurology at URMC and the trial’s lead investigator.

Other phototherapy approaches are being developed as potential treatments for Parkinson’s symptoms, including red light therapy.

The post Developer launches long-awaited study of light device for Parkinson’s appeared first on Parkinson's News Today.

https://parkinsonsnewstoday.com/news/photopharmics-launches-pivotal-trial-parkinsons-light-device/

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