PhotoPharmics Enrolls First 25 Patients in Pivotal Parkinson’s Disease Study to Improve Symptoms Beyond the Current Standard of Care
13 Mayo 2024 - 9:00AM
Business Wire
Groundbreaking at-home pivotal trial of a
much-anticipated therapeutic device is underway
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
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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
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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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Brett Walker Marketing Officer 801.361.6600
brett.walker@photopharmics.com