PhotoPharmics Completes Pivotal, Phase 3, Light for PD Clinical Trial; to Present Topline Data at World PD Congress

Completion of 351-patient trial marks key milestone for the Celeste® investigational photo-neuromodulation program; topline data presented May 26 in Phoenix

SALT LAKE CITY, UT, UNITED STATES, May 15, 2026 /EINPresswire.com/ -- PhotoPharmics, a medical device company developing Celeste^®, an investigational photo-neuromodulation device for Parkinson's disease, today announced Last Patient Last Visit in its Pivotal, Phase 3 Light for PD clinical trial. The University of Rochester Medicine's Clinical Trials Coordination Center (CTCC) conducted all participant visits and trial coordination. The completion of all participant activity is a critical step in the Celeste^® program.

The Light for PD trial was a fully remote, randomized, double-blind, sham-controlled trial evaluating Celeste in individuals living with Parkinson's disease. The trial enrolled 351 participants across the United States. With all participant activity now complete, the company will proceed with database lock and final data analysis.

PhotoPharmics will present topline results from the Light for PD trial to healthcare professionals at the World Parkinson Congress (WPC), taking place May 25–27, 2026, in Phoenix. The presentation is scheduled for May 26 at 7:45 AM in Room 224. The company will also exhibit at Booth #520 throughout the congress.

"This milestone belongs first to the patients — people living with Parkinson's disease who contributed their time to a trial aimed at advancing new approaches to care," said Kent Savage, Chief Executive Officer and Co-Founder of PhotoPharmics. "We are grateful to the care partners, investigators, and coordinators who made this program possible and look forward to sharing the trial findings with the clinical community."

Ray Dorsey, MD, lead investigator and a Professor of Neurology at University of Rochester Medicine, said, “The Light for PD trial was designed to rigorously evaluate a hypothesis that has been building in the scientific literature for years — that circadian biology and Parkinson's disease are meaningfully connected, and that a precisely controlled light intervention could have an impact across both motor and non-motor domains. Completing trial visits in a fully remote, 351-person pivotal trial is itself a scientific achievement. We look forward to examining the results of the trial.”

Parkinson's disease remains a complex, progressive condition with substantial unmet needs — particularly for the persistent motor and non-motor signs and symptoms not fully addressed by existing therapies. Celeste^® is an investigational device designed to deliver precisely tuned light to the eyes to engage melanopsin-containing intrinsically photosensitive retinal ganglion cells (ipRGCs) and associated neural pathways believed to play a role in circadian dysregulation, sleep, and other dysfunction.

The Pivotal, Phase 3 trial adds to prior clinical experience, which informed trial design and supported further evaluation in a larger, controlled setting. The trial was designed to evaluate Celeste^® across a broad population of individuals living with Parkinson's disease in a real-world, home-use setting — without clinic visits, travel, or modifications to existing medical care.

"The conclusion of participant follow-up represents the culmination of years of scientific work and a major step to completion of an innovative and patient-oriented trial design," said Karl Kieburtz, MD, MPH, Chief Medical Officer of PhotoPharmics. "We built this trial to be rigorous — remote assessments, double-blinded, and designed to evaluate outcomes across both motor and non-motor measures. We now have the opportunity to analyze a dataset that this trial was designed to generate."

"This trial reflects a decade of work to better understand how precisely timed, specialized wavelengths of light can engage neural systems relevant to Parkinson's disease," said Dan Adams, Chief Science Officer and Co-Founder of PhotoPharmics. "With completion of the trial, we now have a comprehensive dataset to further evaluate photo-neuromodulation as a novel, non-invasive approach under investigation in Parkinson's disease."
Celeste^® has received Breakthrough Device designation from the U.S. Food and Drug Administration, a U.S.-specific program with no equivalent in other jurisdictions. Following data readout, PhotoPharmics plans to advance regulatory activities, including a De Novo submission to the FDA.

About the Light for PD Trial
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The Light for PD trial is a Pivotal, Phase 3, randomized, double-blind, sham-controlled clinical trial evaluating Celeste^® in 351 participants with Parkinson's disease. The trial was conducted fully remotely across the United States, incorporating digital tools to support daily device use and structured outcome assessments. No clinic visits were required.

About Celeste^®
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Celeste^® is an investigational photo-neuromodulation device designed for daily, at-home use. It delivers precisely tuned light exposure through the eyes to engage melanopsin-containing intrinsically photosensitive retinal ganglion cells (ipRGCs) and associated neural pathways believed to play a role in circadian regulation.

Celeste^® has received Breakthrough Device designation from the U.S. Food and Drug Administration, a U.S.-specific program with no equivalent in other jurisdictions, which is intended to expedite development and review but does not constitute marketing authorization. Celeste^® is an investigational device and has not been authorized for marketing in any jurisdiction.

About PhotoPharmics
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PhotoPharmics, Inc. is a privately held, medical device company developing an investigational photo-neuromodulation device for Parkinson's disease. The company's founders bring more than 30 years of experience in light-based neuroscience and were involved in the development of early clinically validated light therapies for seasonal affective disorder, sleep disruption, anxiety, and depression.

PhotoPharmics is advancing a pipeline of investigational, home-use devices. Its lead program, Celeste^®, has completed a Pivotal, Phase 3 clinical trial. Learn more at www.photopharmics.com.

Forward-Looking Statements
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This press release contains forward-looking statements, including statements regarding anticipated data presentations, regulatory plans, and potential future developments. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. PhotoPharmics undertakes no obligation to update these statements except as required by law.

Important Safety Information: Celeste^® is an investigational device. Limited by federal (U.S.) law to investigational use. Celeste is not CE marked and not available for use in the EU. Celeste is not for sale.

PR#2602515

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