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PhotoPharmics Launches Largest Phototherapy Trial for Parkinson's Disease

PhotoPharmics Launches Largest Phototherapy Trial for Parkinson's Disease

PhotoPharmics  announced the initiation of a groundbreaking pivotal trial. The 'Celeste Light for PD Trial' (found at lightforpd.com) represents a significant stride in Parkinson’s disease (PD) treatment, leveraging innovative Spectramax™ technology through the passive and non-invasive Celeste® phototherapy device.

This pivotal trial will assess the efficacy of Celeste®, the company’s FDA Breakthrough phototherapy device to improve non-motor and motor function and quality of life in Parkinson’s disease (PD). The Celeste device builds on the company’s innovative Spectramax™ technology that has been successfully used in previous human research. This 300-patient phototherapy trial will be the largest trial of its kind.

Kent Savage, President and CEO of PhotoPharmics, underlined the importance and anticipation surrounding the trial. "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," he stated. The trial follows the FDA’s Breakthrough Device Designation for the Celeste® device in April 2020, acknowledging its potential in treating PD.

Dan Adams, Chief Science Officer at PhotoPharmics, reflected on the significant outcomes of the previous trials. "Our initial trials demonstrated remarkable improvements in both quality of life and non-motor symptoms for PD patients, offering a new horizon in PD treatment," Adams said. The MDS-UPDRS Parts 1+2 and the PDQ 39 showed very large clinical benefit, indicating substantial improvements in patients' day-to-day function and quality of life.

The Celeste phototherapy device is based on the understanding that PD damages the retina and impacts the circadian system and various symptoms such as tremor to sleep, cognition, depression, and fatigue. Targeting photoreceptors in the eye responsible for circadian signaling, Celeste® offers a unique and non-invasive treatment approach.

Dr. Ray Dorsey, Professor of Neurology at URMC and lead investigator, emphasized the trial's at-home, telemedicine-based format. "The convenience of assessing patients' progress at home makes this trial particularly relevant and accessible," he noted. This approach allows for broader participation, including individuals in remote locations.

The six-month trial will involve 300 participants enjoying the Celeste® device daily during their usual evening activities. This non-invasive therapy complements current medical care, requiring no alteration to existing medical regimes. The telemedicine approach improves access to care by delivering an FDA breakthrough therapy to patients nationwide independent of their proximity to major clinics.

The Celeste trial is poised to address the widespread, critical unmet needs such as sleep disturbances, fatigue, depression, anxiety, and cognition for which there are currently no FDA approved therapies. These symptoms are often more debilitating than motor symptoms and can significantly deteriorate the quality of life.

“A pivotal trial for medical devices is similar to a phase 3 trial drug trial,” said Dan Adams, chief science officer. “As patients reported in our prior trial, this may be the only treatment that improves functional abilities in PD when administered on top of current medication. We recently presented our new trial design to the FDA with a favorable review.”

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More news about: global pharma | Published by Manvi | March - 27 - 2024 | 327

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