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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