Presentation to Highlight Feasibility and Interest in Decentralized Home-Based Phase 3 Trial
Salt Lake City, Utah — December 5, 2024 — PhotoPharmics, a pioneer in non-invasive phototherapy for neurological disorders, today announced it will present a poster titled “An Entirely Remote, Home-based Phase 3 Clinical Trial of a Specialized Light Therapy Device for Parkinson’s Disease – Interest and Feasibility” at the Parkinson Study Group (PSG) Annual Meeting in Nashville, Tennessee. The poster session is scheduled for Thursday, December 5, from 5:00–7:00 PM CST.
The presentation will highlight recruitment and enrollment results from the company’s innovative Phase 3 Light for PD clinical trial and highlights the feasibility and interest in a fully remote, home-based study design for its Celeste light therapy device.
A New Era in Decentralized Parkinson’s Trials
The trial represents a significant step forward in clinical research, with nearly 3,000 participants completing the eligibility questionnaire across all 50 U.S. states. Of these, 1,316 individuals were identified as potentially eligible, showcasing strong interest in decentralized trials.
“We are excited to share the success and insights of this fully remote trial design,” said Kent Savage, Chief Executive Officer of PhotoPharmics. “The results so far demonstrate the power of remote trials to improve accessibility and inclusion in clinical research. This model has the potential to transform how we conduct trials for Parkinson’s disease and beyond. It’s on the cutting edge of telemedicine, showing us that access to specialists is possible for those who otherwise would not be able to participate.”
(click image to view poster)
Remote Trial Design and Participant Insights
Participants in the Light for PD trial use the Celeste device, a specialized phototherapy treatment, at home for one hour each evening over a six-month period. Clinical outcomes, including changes in the Parkinson’s Disease Questionnaire (PDQ-39) and the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), are monitored remotely.
Early findings reveal that while some participants faced challenges with remote consent and software use, device setup and operation were universally successful. Enrolled participants averaged 67.8 years of age, with a mean Parkinson’s disease duration of 6.8 years.
“Remote trials like Light for PD can break down barriers that prevent people in rural or underserved areas from accessing innovative therapies,” Savage added. “People with Parkinson’s who typically don’t have access to clinical trials are particularly interested in our trial. This is about inclusivity, patient convenience, and moving closer to real-world results for therapies like Celeste.”
Authors of the poster presentation include Ray Dorsey, Dan Adams, Suzanne Hendrix, Bradley Wyman, Christi Alessi-Fox, Jamie Adams, Karen Clark, Michelle Porto, Grace Nkrumah, Katrina Schmier, Kathryn Murphy, Sarrah Hussain, Melissa Kostrzebski, and Karl Kieburtz.
Invitation to Learn More
The PhotoPharmics team invites attendees of the PSG Annual Meeting to visit their poster presentation on December 5 to explore the trial design, early results, and implications for future clinical research.
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.
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PR12002
Milestone Marks Significant Progress in Establishing Non-invasive Phototherapy Treatment for Parkinson’s Disease
Salt Lake City, Utah, September 29, 2024 — PhotoPharmics, a leader in non-invasive phototherapy for neurological disorders, has reached a significant milestone in its ongoing FDA pivotal “Light for PD” trial for the Celeste therapeutic device. The first subject has successfully completed the full 6-month treatment course and clinical visits, marking an important step towards the successful completion of the trial and future FDA authorization of Celeste in treating Parkinson’s disease (PD).
“We are thrilled to reach this milestone,” said Kent Savage, CEO of PhotoPharmics. “This marks significant progress for this groundbreaking study. While it is too early to know results, we are optimistic that the Celeste device can represent a significant advancement in treating Parkinson’s.”
A Closer Look at the “Light for PD” Trial
The “Light for PD” trial aims to demonstrate the safety and efficacy of Celeste, PhotoPharmics’ non-invasive phototherapy device in treating PD, a neurodegenerative disease impacting over 11 million people globally. Celeste passively delivers specialized wavelengths of therapeutic light to neurons in the eye that signal areas of the brain responsible for sleep, wakefulness, mood and energy. Just as Parkinson’s medications boost damaged motor signaling in brain, Celeste’s specialized phototherapy stimulates the eye’s damaged photoreceptor signaling.
PD results from the degeneration of dopamine-producing neurons, leading to symptoms like tremors, rigidity, and cognitive decline. Current treatments are largely pharmacological, but there is growing demand for non-invasive, non-pharmacological treatments for both motor and non-motor symptoms in PD. Celeste offers the potential to complement or enhance existing treatments.
Subjects in the trial receive daily phototherapy sessions over a 6-month period. The study, conducted remotely across the U.S., will provide critical data on the device’s safety and efficacy.
“Our focus has always been on improving the lives of Parkinson’s subjects,” added Dan Adams, Science Officer at PhotoPharmics. “We believe Celeste could address both the motor and non-motor symptoms of PD beyond current medical care, offering a simple, passive treatment option.”
Subject Demand
Subject demand continues to outpace openings in the trial. PhotoPharmics looks to finalize enrollment before the end of the year and the company anticipates final data in late 2025. The data will guide the regulatory approval and reimbursement processes.
“Our optimism stems from high levels of subject engagement and their adherence to the therapy,” noted Savage. “There is a clear demand for novel treatments, and both clinicians and participants have responded positively.”
Subject and Clinician Perspectives
Those participating in the trial have expressed hope about the therapy’s potential. “The ‘Light for PD’ treatment has given me renewed hope,” said a trial applicant. “It’s easy to use, and I’m optimistic about its benefits.”
Clinicians are also supportive. “The ‘Light for PD’ device represents a promising addition to Parkinson’s treatments,” said Savage. “We are hopeful this technology can provide an alternative for subjects who struggle with the side effects of traditional treatments.”
The Science Behind Phototherapy
Phototherapy has been used successfully to treat conditions like seasonal affective disorder (SAD) and certain skin conditions. However, applying this therapy to neurological disorders like PD is relatively new. The Celeste device uses light to activate neural pathways that may alleviate symptoms of PD.
“Phototherapy is an exciting approach to age-related neurological disorders,” explained Adams. “In addition to the damage that occurs in the brain, new discoveries show similar damage in the eye which normally works with the brain to regulate most physiological function. This is the first device that stimulates the eye’s non-visual photoreceptors which are damaged from neurodegeneration. We believe this will alleviate symptoms in a way that is drug-free and non-invasive.”
Unlike many pharmacological treatments, phototherapy is generally well-tolerated, with no serious adverse events reported in the trial so far.
Next Steps and Future Outlook
“Our goal is to make this therapy widely accessible,” said Savage. “We are working closely with regulatory authorities, payers, and providers to ensure the device reaches the market as quickly as possible.”
In the future, PhotoPharmics plans to explore additional applications for its phototherapy technology in other neurological and psychiatric conditions.
Forward-Looking Statements:
This press release contains forward-looking statements regarding the “Light for PD” trial. These statements are based on current expectations but are subject to risks and uncertainties. There is no guarantee of final outcomes or regulatory approval.
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 subject’s lives by delivering safe and effective treatments. Learn more at www.photopharmics.com.
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PR11702
Company Strengthens Its Leadership in Neurodegenerative Disease Research with New Advisory Board Members
PhotoPharmics, an innovator in light-based therapies for neurodegenerative diseases, proudly announces the appointment of three eminent experts to its Clinical & Scientific Advisory Board (CSAB). The new members—Dr. Charles H. Adler, Dr. George Brainard, and Dr. Robert A. Hauser—bring unparalleled expertise to the advisory board, reinforcing PhotoPharmics’ mission to pioneer groundbreaking treatments for Parkinson’s disease and other neurodegenerative disorders.
Dr. Charles Adler, Dr. George Brainard, and Dr. Robert Hauser (left to right)
“We are honored to welcome Dr. Adler, Dr. Brainard, and Dr. Hauser to our Clinical & Scientific Advisory Board,” said Kent Savage, CEO of PhotoPharmics. “Their expertise and groundbreaking research are invaluable as we continue to develop our light-based therapies. These additions underscore our commitment to advancing innovative treatments that improve the lives of patients worldwide.”
The addition of these three leading experts to PhotoPharmics’ Clinical & Scientific Advisory Board marks a pivotal step in the company’s mission to harness the power of light-based therapies for neurodegenerative disease treatment. A brief background on each includes:
- Charles H. Adler, M.D., Ph.D., is the Wayne and Kathryn Preisel Professor of Neuroscience Research and a Professor of Neurology at Mayo Clinic Arizona, where he co-leads the Arizona Study of Aging and Neurodegenerative Disorders. He has published over 600 research papers, focusing on diagnosing and treating movement disorders such as Parkinson’s disease, essential tremor, and dystonia. Dr. Adler’s research also includes exploring biomarkers for early Parkinson’s diagnosis and investigating chronic traumatic encephalopathy (CTE). He has held leadership positions in the International Parkinson and Movement Disorder Society and received numerous awards for his contributions to the field.
- George C. Brainard, M.A., Ph.D., is a professor at Thomas Jefferson University, where he has directed the Jefferson Light Research Program since 1984. His pioneering research examines how light affects human neuroendocrine physiology and circadian rhythms. Dr. Brainard is widely known for his work on melatonin regulation, which led to the discovery of a new class of photoreceptors in the eye. His research has applications in treating seasonal affective disorder (SAD), developing lighting countermeasures for astronauts, and improving lighting designs for healthcare and architectural purposes. He has published over 100 research articles and received numerous awards, including NASA’s Johnson Space Center Director’s Innovation Award.
- Robert A. Hauser, M.D., MBA, is the Director of the Parkinson’s Disease and Movement Disorders Center at the University of South Florida (USF) Health Morsani College of Medicine. A leading neurologist with over 350 peer-reviewed publications, Dr. Hauser is one of the most cited experts in Parkinson’s disease. His research focuses on developing new treatments for Parkinson’s and other movement disorders. He is also highly regarded for his expertise in clinical trial design and the development of outcome measures that have become global standards in the field.
Dr. C. Warren Olanow, M.D., chairman of the CSAB, added, “The inclusion of Drs. Adler, Brainard, and Hauser significantly enhances our board’s capabilities. Their unique perspectives will guide our research and clinical efforts, ensuring PhotoPharmics remains at the forefront of innovation in treating neurodegenerative diseases.”
These distinguished professionals join an accomplished advisory board, which also includes:
- Ray Chaudhuri, M.D. – A global authority on the non-motor symptoms of Parkinson’s disease and professor of neurology/movement disorders at King’s College London.
- Dr. Rajesh Pahwa, M.D. – Chief of the Parkinson’s and Movement Disorder Division at the University of Kansas Medical Center, with expertise in over 100 clinical trials.
- Dr. Joohi Jimenez-Shahed, M.D. – Medical Director of Movement Disorders Neuromodulation at Mount Sinai Hospital, specializing in deep brain stimulation (DBS) and digital health technologies.
- Dr. Dan Claassen, M.D., M.S. – Chief of Behavioral and Cognitive Neurology at Vanderbilt University, with a focus on neurodegenerative disorders affecting cognition, behavior, and movement.
- Dr. Amy Amara, M.D., Ph.D. – A leading researcher at the University of Alabama at Birmingham, specializing in sleep disorders in Parkinson’s disease.
For full details on the CSAB members, please visit here.
The Clinical & Scientific Advisory Board (CSAB) of PhotoPharmics serves as a critical resource for guiding the company’s research and development efforts. Comprised of leading experts in neurology, movement disorders, and light-based therapies, the CSAB provides strategic advice on clinical trial design, scientific research, and the development of innovative treatments. The board’s purpose is to ensure that PhotoPharmics’ products are grounded in the latest scientific evidence, meet the highest standards of safety and efficacy, and address the unmet needs of patients with neurodegenerative diseases. By leveraging the collective expertise of its members, the CSAB plays a vital role in advancing PhotoPharmics’ mission to improve patient outcomes through groundbreaking therapies.
About PhotoPharmics
PhotoPharmics is a privately held, clinical-stage medical device company pioneering the development of next-generation light-based therapies for neurodegenerative disorders, with a primary focus on Parkinson’s disease. The company is currently conducting a landmark Phase 3 clinical trial—the first of its kind to evaluate a non-invasive light therapy device for Parkinson’s disease at this level. The trial is underway and aims to assess the impact of light therapy on both motor and non-motor symptoms, with the potential to transform the standard of care for patients.
Building on over 30 years of innovation, PhotoPharmics’ founders have a legacy of pioneering light solutions, including those acquired by Philips-Respironics in 2007. The company remains committed to delivering safe, effective, and non-invasive treatments that improve quality of life. For more information and investor inquiries, visit www.photopharmics.com.
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PR11701
