351-patient trial completion marks a key milestone for the Celeste® program; topline data to be presented May 26 in Phoenix
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
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®
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
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
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
Company available for scientific exchange as pivotal study approaches completion. Data Readout Anticipated at World Parkinson Congress.
SALT LAKE CITY, UT, UNITED STATES, April 16, 2026 /EINPresswire.com/ — PhotoPharmics, a clinical-stage medical device company advancing an investigational photo-neuromodulation device for Parkinson’s disease, today announced that members of its leadership and clinical team will attend the American Academy of Neurology Annual Meeting, taking place April 18–22 in Chicago.
The company’s participation coincides with the final weeks of its pivotal Phase 3 Light for PD clinical trial — a fully remote, randomized, double-blind, placebo-controlled study evaluating Celeste®, an investigational photo-neuromodulation device, in individuals living with Parkinson’s disease. Topline results are anticipated to be shared at the World Parkinson Congress in late May 2026.
“AAN convenes the clinicians and researchers who are shaping the future of Parkinson’s care,” said Kent Savage, Chief Executive Officer and Co-Founder of PhotoPharmics. “We value the opportunity to engage with this community as our pivotal study approaches completion and as we prepare to share data from what we believe is a meaningful program for people living with this disease.”
The Light for PD trial enrolled 350 participants across the United States, exceeding its original enrollment target. Celeste has received Breakthrough Device designation from the U.S. Food and Drug Administration.
Dan Adams, Chief Science Officer and Co-Founder of PhotoPharmics, added: “The scientific community has long recognized the relationship between circadian biology and neurodegeneration, and prior published work has examined whether light-based interventions can influence the symptoms of Parkinson’s disease across both motor and non-motor domains. The Light for PD trial was designed to rigorously test that hypothesis using a controlled, standardized approach. We look forward to sharing our results.”
PhotoPharmics representatives will be available throughout the AAN meeting for discussions with neurologists, movement disorder specialists, clinical collaborators, and potential strategic partners.
About Celeste®
Celeste is an investigational photo-neuromodulation device designed to deliver 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. The device is being evaluated for potential daily, at-home use as an adjunct to existing care.
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. Celeste is an investigational device and has not been authorized for marketing by the FDA.
About PhotoPharmics
PhotoPharmics is a privately held, clinical-stage medical device company developing an investigational photo-neuromodulation device for Parkinson’s disease. The company’s approach uses precisely tuned light delivered through the eyes to engage neural systems believed to play a role in circadian function.
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®, is currently being evaluated in a pivotal Phase 3 clinical trial. Learn more at www.photopharmics.com.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the anticipated timing and completion of the Light for PD clinical trial, expected data presentations, and future regulatory activities. 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.
#PR260416
PhotoPharmics, a clinical-stage medical device company pioneering Photo Neuromodulation for neurodegenerative disease, today announced it has surpassed its enrollment target with 350 participants in its pivotal, Phase 3 Light for PD clinical trial evaluating the Celeste® device for people living with Parkinson’s disease.
“Exceeding our target and closing enrollment is a remarkable milestone for the Parkinson’s community,” said Kent Savage, Chief Executive Officer of PhotoPharmics. “We’re proving that rigorous science can be both patient-centered and home-based. We’re deeply grateful to our investigators, study teams, and especially our participants and their families, whose courage and commitment make this work possible.”
The first-of-its-kind, fully remote, six-month, randomized, double-blind, placebo-controlled Phase 3 trial is evaluating Celeste, a non-drug, at-home therapy designed to complement best medical care and address the large number of unmet clinical needs in PD. Conducted nationwide through a decentralized telemedicine model, participants use the Celeste device in their homes while connecting with study teams via secure video visits.
Celeste delivers precisely calibrated light through the eyes to activate retinal cells that communicate with brain regions regulating circadian rhythms, alertness and activity, mood, and cognition. By helping to restore this critical retinal to brain signaling, the therapy aims to reduce non-motor symptoms—such as sleep disruption, fatigue, apathy, anxiety and depression and cognition. Improving non-motor symptoms also results in better motor function, making this the first potential treatment that profoundly affects the quality of life for people with Parkinson’s disease.
“Clinical trials are the bridge between discovery and hope,” said Dan Adams, Chief Science Officer at PhotoPharmics. “This remote design demonstrates that cutting-edge research can meet patients where they live—literally—while maintaining the same rigor and data quality of traditional site-based trials.”
PhotoPharmics expects top-line results in Q2 2026, following completion of the trial and subsequent data analysis. The company remains optimistic about the potential of Celeste to improve the lives of those with Parkinson’s disease and is encouraged by the U.S. Food and Drug Administration’s Breakthrough Device designation, recognizing the therapy’s potential to provide significant improvement over existing treatment options.
“Our mission has always been patient first,” added Savage. “Celeste isn’t just another pill or patch—it’s a convenient, easy daily therapy that fits into life at home. The generosity of those who participated in this trial helps advance science and brings real hope to millions.”
About PhotoPharmics
PhotoPharmics is a privately held, clinical-stage medical device company pioneering photo-neuromodulation therapy—the use of precisely tuned light through the eyes to stimulate neural systems that regulate circadian and dopaminergic function. The company’s founders each bring more than 30 years of experience in light-based neuroscience and developed one of the first clinically validated light therapies for seasonal affective disorder, sleep disruption, anxiety, and depression—technology later acquired by Philips-Respironics in 2007.
Building on that legacy, PhotoPharmics is advancing a new generation of evidence-based, home-use therapies for neurodegenerative disease. Its lead program, the Celeste® device for Parkinson’s disease, is currently in a pivotal Phase 3 clinical trial and has received FDA Breakthrough Device designation. The company’s mission is to make a clinically meaningful difference in patients’ lives by delivering safe, effective, and accessible treatments that work naturally with the body’s own rhythms.
Learn more at www.photopharmics.com.
Forward-Looking Statements
This press release contains forward-looking statements, including but not limited to statements regarding the design, conduct, timing, and expected results of the Light for PD clinical trial; the potential safety, efficacy, and benefits of the Celeste® device; and future regulatory submissions or approvals. These statements are based on current expectations, assumptions, and estimates and are subject to risks and uncertainties that could cause actual results to differ materially from those described. Such risks include, among others, the inherent uncertainties of clinical development, trial outcomes, regulatory review, and commercialization efforts. PhotoPharmics undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
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PR251106
PhotoPharmics, Inc. today announced the peer-reviewed publication of results from its Phase 2 randomized, double-blind, controlled clinical trial evaluating Celeste®, an investigational photo-neuromodulation device, in people living with Parkinson’s disease (PD). The study has been published in the journal Neurotherapeutics. Celeste® has been designated by the U.S. Food and Drug Administration as a Breakthrough Device.
