SALT LAKE CITY–(BUSINESS WIRE)–Sep 28, 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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SOURCE: PhotoPharmics
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PUB: 09/28/2024 09:00 AM/DISC: 09/28/2024 09:02 AM
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