Recruitment for Non-Invasive Parkinson’s Pivotal Study Slated for December
Non-invasive Parkinson’s therapeutic device moves one step closer to FDA clearance, with important potential non-motor and motor improvements for patients.
The maker of the widely anticipated Celeste® specialized phototherapy device, PhotoPharmics, today announced plans to begin recruitment for the Celeste Light for PD trial in December.
“Multiple forces have aligned to make the timing for our pivotal clinical study here and now,” said Kent Savage, PhotoPharmics CEO. “We have leveraged this time to work with FDA, gather input from our clinical advisory board, and coordinate with the trial team at the University of Rochester Medical Center. Once we finalize related funding details, recruitment will begin in earnest.”
Savage added, “Fortunately, demand for non-pharmaceutical and non-invasive solutions like Celeste from people with Parkinson’s and their care partners has only increased. We have heard from thousands of people patiently waiting for the opportunity to experience the benefits of Celeste.”
The Celeste device delivers specialized wavelengths and intensities of light that target the activation of the melanopsin receptors in the eye. These photoreceptors are critical to the circadian pathway that is damaged in Parkinson’s disease.
This pivotal, or phase 3 trial, builds on an earlier company-sponsored positive proof-of-concept clinical study which led to FDA Breakthrough device designation.
Ray Dorsey, MD, lead investigator for the Celeste trial and professor of neurology at the University of Rochester Medical Center, earlier said, “A stay-at-home trial featuring a non-invasive device is perfect for our time. Anyone with Parkinson’s from across the country will be able to apply, even those in remote locations as long as they have an internet connection.”
“Celeste has great promise, given the clinical results to date, its simple non-invasive approach, and its ability to be used along with all available PD therapies,” said Dr. Karl Kieburtz, chief medical officer at PhotoPharmics. “For most people with Parkinson’s, no current therapies fully resolve their symptoms and quality of life continues to deteriorate.
“We are eagerly working with the trial team at CHeT to finalize trial preparations and begin recruitment,” Savage said. “Validating the therapeutic benefits and safety of Celeste through a trial of this magnitude is our company’s highest priority.”
The Center for Health + Technology (CHeT) is a clinical research organization within the University of Rochester Medical Center. Their team designs and conducts multi-center clinical trials with collaborators from across the globe to accelerate clinical research and advance the development of therapeutics, benefiting individuals in our community and beyond. Since its inception over three decades ago, CHeT has reshaped the conduct of clinical trials, from incorporating novel technologies into clinical trial design to modeling disease progression. Learn more at https://www.urmc.rochester.edu/health-technology.aspx.
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 in seasonal affective disorder, sleep disorders, anxiety, and depression (acquired by Philips-Respironics in 2007).
The PhotoPharmics Clinical and Scientific Advisory Board (CSAB) is chaired by C. Warren Olanow, MD, and draws on the expertise of world leaders in Parkinson’s disease including Ray Chaudhuri, MD, Rajesh Pahwa, MD, Joohi Jimenez-Shahed, MD, Dan Claassen, MD, MS, and Amy Amara, MD, PhD. Details at https://photopharmics.com/advisory-board/.
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 patients’ lives by delivering safe and effective non-invasive treatments. Investor inquiries are welcomed. Learn more at www.photopharmics.com.