Innovative Study Advances to Critical Phase in Evaluating Light Therapy for Parkinson’s Disease

PhotoPharmics, a leader in neurodegenerative disease phototherapy, today announced the enrollment of the first 100 subjects in its Light for PD clinical trial. This marks a significant milestone in evaluating Celeste, the company’s FDA Breakthrough light therapy device for Parkinson’s disease (PD). Organizers are on track to enroll 300 subjects—interested individuals with PD may find details at lightforpd.com.

The Light for PD trial is a randomized, double-blind, placebo-controlled study that aims to demonstrate safety and significant improvement in motor and non-motor symptoms beyond current medical care in PD.  Parkinson’s disease happens when the brain can no longer regulate essential signaling for movement and other function. Recent discoveries implicate the eyes as part of this signaling process. Celeste passively delivers specific wavelengths of light aimed to restore retinal signaling, improving function and quality of life for those living with PD.

“We are thrilled to reach this important milestone,” said Kent Savage, CEO of PhotoPharmics. “We are grateful for the team at the University of Rochester’s Center for Health + Technology (CHeT) and the movement disorder neurologists across the country who are enrolling and caring for trial participants. We believe our passive and non-invasive specialized phototherapy device will provide substantial benefits to those affected by this debilitating disease.”

“We are delighted to reach this milestone in the Light for PD trial, which represents a significant step forward in exploring innovative treatments for Parkinson’s disease,” said Dr. Ray Dorsey, Professor of Neurology at URMC and lead investigator for the trial. “This study leverages cutting-edge phototherapy to potentially improve motor and non-motor symptoms, offering new hope to patients. The collaboration with PhotoPharmics and the dedication of the participants underscores the importance of advancing research to find effective solutions for neurodegenerative diseases.”

About the Light for PD Clinical Trial

Participants use the Celeste device one hour daily during activities such as reading, eating, or watching TV. This passive, non-invasive therapy complements existing medical treatments without requiring changes to current medication regimens. The trial’s at-home, telemedicine-based format enhances accessibility and convenience, allowing broader participation, including individuals in remote areas.

The primary endpoints of the study include improvements in overall quality of life, motor function, sleep quality, mood, and cognition, measured through clinical scales and patient-reported outcomes. Preliminary research and early-phase studies have shown promising results, indicating that specialized phototherapy can significantly impact PD symptoms without major side effects. This innovative approach could offer a new, non-invasive treatment option, providing relief and enhancing daily life for PD patients.

“We are committed to advancing the application of specialized phototherapy for neurodegenerative diseases,” said Dan Adams, Science Officer at PhotoPharmics. “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.”

Commitment to Innovation

PhotoPharmics is dedicated to pioneering new medical treatment frontiers by deeply understanding specialized light’s therapeutic potential. The company’s proprietary technologies are grounded in rigorous scientific research and clinical validation, ensuring each product meets the highest efficacy and safety standards.

As the Light for PD trial progresses, PhotoPharmics remains focused on transforming the treatment landscape for Parkinson’s disease. The company is also exploring its light therapy technology for other neurodegenerative diseases, such as Alzheimer’s and Huntington’s disease.

“We are excited about the prospects of expanding our light therapy technology to other conditions,” said Savage. “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.”

About CHeT

The Center for Health + Technology (CHeT) is a clinical research organization within the University of Rochester. Their team designs and conducts multi-center clinical trials with collaborators from across the globe to accelerate clinical research and advance the development of therapeutics, benefiting individuals in our community and beyond. Since its inception over three decades ago, CHeT has reshaped the conduct of clinical trials, from incorporating novel technologies into clinical trial design to modeling disease progression. Learn more at https://www.urmc.rochester.edu/health-technology.aspx.

About PhotoPharmics

PhotoPharmics is a privately held, clinical-stage medical device company developing next-generation treatments for treating neurodegenerative disorders through the eyes. Company founders have 30+ years of research and experience in this field. They previously developed specialized light solutions now widely used to regulate circadian rhythms for seasonal affective disorder, sleep disorders, anxiety, and depression (acquired by Philips-Respironics in 2007).

Drawing from research and recent trials, PhotoPharmics is developing applications of specialized light across several neurodegenerative diseases. The company aims to make a clinically meaningful difference in patient’s lives by delivering safe and effective treatments. Learn more at www.photopharmics.com.

Groundbreaking at-home pivotal trial of a much-anticipated therapeutic device is underway

​May 13, 2024, Salt Lake City, UT – PhotoPharmics, the leader in specialized phototherapy for neurodegenerative diseases, today announced the successful enrollment of its first 25 patients into the Celeste Light for PD Trial. This groundbreaking trial represents a significant advancement in Parkinson’s disease (PD) treatment, where motor treatments become less effective over time, and no FDA approved treatments exist for many debilitating non-motor symptoms.

“People with Parkinson’s have told us they need answers for these debilitating symptoms that aren’t well treated with current medicines, and the last thing they want is another drug,” said Kent Savage, president & CEO of PhotoPharmics. “So, our goal has been to provide a non-invasive therapy that would significantly improve Parkinson’s symptoms beyond what is currently available.”

“We knew awareness of this new approach was high among the Parkinson’s community, but when we started recruiting, we were overwhelmed by the volume of applications to participate in this pivotal trial,” continued Savage. “After a tremendous amount of work, we are pleased to announce the enrollment of the first 25 patients in the Celeste Light for PD Trial, marking a pivotal moment in our journey to revolutionize PD care.” The non-invasive Celeste phototherapy device has been designated a Breakthrough Treatment by FDA.

Savage added, “We extend our gratitude to our stakeholders, especially the team at the University of Rochester and the movement disorder neurologists who are helping to make this advancement become available to the millions of Parkinson’s sufferers worldwide.”

Light for PD Trial

The pivotal trial aims to demonstrate the efficacy of the Celeste phototherapy device in improving both motor and non-motor function and overall quality of life for patients with Parkinson’s disease beyond current medical care. The trial will enroll 300 participants, who will enjoy the Celeste device for one hour daily during their usual evening activities (reading, eating, or watching TV) while therapeutic light gently bathes their faces. This passive, non-invasive therapy complements current medical care, and requires no alteration to existing medical regimens. In addition, the telemedicine approach of the Light for PD trial improves access to care by delivering an FDA breakthrough therapy to eligible participants without requiring them to travel to a clinic.

• Innovative Treatment Approach: The Celeste phototherapy device offers a novel, non-invasive treatment approach, targeting photoreceptors in the eye responsible for circadian and physiological function. By addressing PD’s underlying mechanisms, it aims to provide a holistic approach to symptomatic improvement and potential disease modification.
• Patient-Centric Design: The trial’s at-home, telemedicine-based format enhances accessibility and convenience, allowing for broader participation, including individuals in remote areas, underscoring our commitment to patient empowerment and engagement.
• Next Steps and Future Implications: The trial aims to advance PD research and treatment, with potential implications for other neurodegenerative diseases. Through continued collaboration and innovation, we will explore treatments in Alzheimer’s and Huntington’s.
• Partnership: The trial is a collaborative endeavor between PhotoPharmics and CHeT, combining scientific expertise and cutting-edge technology to advance PD research and treatment. Building on past successes and research efforts, this trial rests on a strong foundation of scientific evidence and innovation.

Those interested may apply at Light for PD Trial or lightforpd.com. Clinicians and other stakeholders can learn more at photopharmics.com.

Celeste Phototherapy

Targeting photoreceptors in the eye responsible for circadian and other non-visual signaling, the Celeste device offers a unique and non-invasive treatment approach to address critical unmet needs in PD, including sleep disturbances, fatigue, psychological health, and cognition, for which there are currently no FDA-approved therapies. These symptoms are often as debilitating as motor symptoms and can significantly deteriorate the quality of life.

“A pivotal trial for medical devices is similar to a Phase 3 drug trial,” said Dan Adams, chief science officer. “As patients reported in our prior trial, this may be the first treatment that improves a broad set of 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.”

Parkinson’s Disease Statistics

PD affects approximately one million individuals in the United States and 10 million worldwide, with about 60,000 Americans diagnosed each year. The disease is progressive, with symptoms worsening over time, leading to an aggravating effect on patients’ lives.

Non-motor symptoms are prevalent, affecting the majority of individuals with PD. These non-motor symptoms significantly contribute to the overall burden of the disease.

About CHeT

The Center for Health + Technology (CHeT) is a clinical research organization within the University of Rochester. Their team designs and conducts multi-center clinical trials with collaborators from across the globe to accelerate clinical research and advance the development of therapeutics, benefiting individuals in our community and beyond. Since its inception over three decades ago, CHeT has reshaped the conduct of clinical trials, from incorporating novel technologies into clinical trial design to modeling disease progression. Learn more at https://www.urmc.rochester.edu/health-technology.aspx.

About PhotoPharmics

PhotoPharmics is a privately held, clinical-stage medical device company developing next-generation treatments for treating neurodegenerative disorders through the eyes. Company founders have 30+ years of research and experience in this field. They previously developed specialized light solutions now widely used to regulate circadian rhythms for seasonal affective disorder, sleep disorders, anxiety, and depression (acquired by Philips-Respironics in 2007).

Drawing from research and recent trials, PhotoPharmics is developing applications of specialized light across several neurodegenerative diseases. The company aims to make a clinically meaningful difference in patients’ lives by delivering safe and effective treatments. Learn more at www.photopharmics.com.

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Pivotal Trial Aims to Improve Overall Function and Quality of Life

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PhotoPharmics, a pioneer in specialized phototherapy for neurodegenerative diseases, alongside the Center for Health + Technology (CHeT) at the University of Rochester Medical Center (URMC), today 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.”

Participating in the Trial

People with Parkinson’s disease and their caregivers may apply to participate in the trial at https://www.lightforpd.com/.

Qualified participants will receive up to $500. No additional pills, surgery, or even doctor’s visits are required. The entire study will be in the comfort of the participant’s home with Zoom video interactions with the medical team.

Focus of the Trial

Current treatments for PD primarily treat motor symptoms, and very few options exist for the debilitating non-motor problems that are also part of the disease. As Parkinson’s progresses, these non-motor issues become even more pronounced and are often the determining factors for quality of life and institutionalization.[1] In fact, the Movement Disorders Society has identified these debilitating non-motor problems as a major unmet therapeutic need.[2]

The LIGHT-PD clinical trial represents a potentially monumental step in PD research and treatment. With its non-invasive approach, broad eligibility criteria, and telemedicine-based design, it stands as a beacon of hope for many. The collaboration between PhotoPharmics and CHeT underscores a commitment to pioneering research and a shared vision of improving the lives of those affected by Parkinson’s Disease.

About CHeT

The Center for Health + Technology (CHeT) is a clinical research organization within the University of Rochester. Their team designs and conducts multi-center clinical trials with collaborators from across the globe to accelerate clinical research and advance the development of therapeutics, benefiting individuals in our community and beyond. Since its inception over three decades ago, CHeT has reshaped the conduct of clinical trials, from incorporating novel technologies into clinical trial design to modeling disease progression. Learn more at https://www.urmc.rochester.edu/health-technology.aspx.

About PhotoPharmics

PhotoPharmics is a privately held, clinical-stage medical device company developing next-generation treatments for treating neurodegenerative disorders through the eyes. Company founders have 30+ years of research and experience in this field. They previously developed specialized light solutions now widely used to regulate circadian rhythms for seasonal affective disorder, sleep disorders, anxiety, and depression (acquired by Philips-Respironics in 2007).

Drawing from research and recent trials, PhotoPharmics is developing applications of specialized light across several neurodegenerative diseases. The company aims to make a clinically meaningful difference in patients’ lives by delivering safe and effective treatments. Learn more at www.photopharmics.com.

[1] Schapira, A., Chaudhuri, K. & Jenner, P. Non-motor features of Parkinson disease. Nat Rev Neurosci 18, 435–450 (2017).

[2] Seppi K, Ray Chaudhuri K, Coelho M, Fox SH, Katzenschlager R, Perez Lloret S, Weintraub D, Sampaio C, collaborators of the Parkinson’s Disease Update on Non‐Motor Symptoms Study Group on behalf of the Movement Disorders Society Evidence‐Based Medicine Committee, Chahine L, Hametner EM. Update on treatments for nonmotor symptoms of Parkinson’s disease—an evidence‐based medicine review. Movement Disorders. 2019 Feb;34(2):180-98.

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