PhotoPharmics Announces First Subject Completes FDA Pivotal Clinical Trial for Celeste Device in Parkinson's Disease

Milestone marks significant progress in establishing non-invasive phototherapy treatment for Parkinson’s disease

SALT LAKE CITY, September 28, 2024–(BUSINESS WIRE)–PhotoPharmics, a leader in non-invasive phototherapy for neurological disorders, has reached an important milestone in its ongoing pivotal FDA “Light for PD” trial for the Celeste therapeutic device. The first subject successfully completed the full 6-month treatment and clinical visits, marking an important step toward trial success and future FDA approval of Celeste for the treatment of Parkinson’s disease (PD).

“We are thrilled to reach this important milestone,” said Kent Savage, CEO of PhotoPharmics. “This marks significant progress for this groundbreaking study. Although it is too early to know the results, we are optimistic that the Celeste device could represent a significant advance in the treatment of Parkinson’s disease.”

A Closer Look at the “Light for PD” Trial

The “Light for PD” trial aims to demonstrate the safety and effectiveness of Celeste, PhotoPharmics’ non-invasive phototherapy device, in the treatment of Parkinson’s disease, a neurodegenerative disease that affects more than 11 million people in the world. 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 stimulate damaged motor signaling in the brain, Celeste’s specialized phototherapy stimulates signaling from damaged photoreceptors in the eye.

PD results from the degeneration of dopamine-producing neurons, leading to symptoms such as tremor, rigidity, and cognitive decline. Current treatments are largely pharmacological, but there is a growing demand for non-invasive, non-pharmacological treatments for motor and non-motor symptoms of PD. Celeste offers the potential to complement or enhance existing treatments.

Trial subjects receive daily phototherapy sessions over a 6-month period. The study, conducted remotely in the United States, will provide essential data on the safety and effectiveness of the device.

“Our goal has always been to improve the lives of people with Parkinson’s disease,” added Dan Adams, Chief Scientific Officer at PhotoPharmics. “We believe Celeste could treat both motor and non-motor symptoms of PD beyond current medical care, providing a simple, passive treatment option.”

Subject Request

Demand for topics continues to outstrip openings in the trial. PhotoPharmics plans to complete registration before the end of the year and the company anticipates final data by the end of 2025. The data will guide regulatory approval and reimbursement processes.

“Our optimism stems from subjects’ high levels of engagement and adherence to therapy,” Savage noted. “There is a clear demand for new treatments, and both clinicians and participants have responded positively. »

Perspectives of the subject and the clinician

Trial participants expressed hope for the therapy’s potential. “The ‘Light for PD’ treatment gave me hope,” said one trial candidate. “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 treatments for Parkinson’s disease,” Savage said. “We hope that this technology can offer an alternative to subjects struggling with the side effects of traditional treatments.”

The science behind phototherapy

Phototherapy has been used successfully to treat conditions such as seasonal affective disorder (SAD) and certain skin conditions. However, the application of this therapy to neurological disorders like PD is relatively new. The Celeste device uses light to activate neural pathways that can alleviate PD symptoms.

“Phototherapy is an exciting approach to age-related neurological disorders,” Adams explained. “In addition to the damage occurring in the brain, new findings show similar damage in the eye which normally works with the brain to regulate most physiological functions. It is the first device to stimulate non-visual photoreceptors of the eye that are damaged by neurodegeneration. We believe this will relieve symptoms in a drug-free and non-invasive way.

Unlike many pharmacological treatments, phototherapy is generally well tolerated and no serious adverse events have been reported so far in the trial.

Next steps and future outlook

“Our goal is to make this therapy widely accessible,” Savage said. “We are working closely with regulatory authorities, payers and providers to ensure the device comes to market as quickly as possible.”

In the future, PhotoPharmics plans to explore additional applications of 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 results or regulatory approval.

About PhotoPharmics

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

Building on recent research and trials, PhotoPharmics is developing specialized light applications in several neurodegenerative diseases. The company aims to make a clinically meaningful difference in people’s lives by providing safe and effective treatments. Learn more at www.photopharmaks.com.

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