PhotoPharmics has enrolled the first patients with Parkinson’s disease (PD) in a study aimed at demonstrating the efficacy of its phototherapy device in improving symptoms of the disease.
The first 25 patients enrolled are part of a 300-strong target for the US-based company in the trial that will provide further evidence for PD treatment.
The pivotal trial for PhotoPharmics’ device, named Celeste, is designed to improve both motor and non-motor function, as well as overall quality of life for patients with PD. A pivotal trial for a medical device is similar to a Phase III trial for a drug, the final stage of clinical research before marketing applications are submitted to regulatory agencies.
The Celest Light for PD trial (NCT04453033), conducted in collaboration with the University of Rochester Medical Centre, will see participants in the US use the Celeste device for one hour a day. Patients’ quality of life will be assessed via questionnaires at 26 weeks.
Whilst there are many US Food and Drug Administration (FDA)-approved drugs for PD, there is a lack of devices on the market that target symptoms beyond tremors.
“Our goal has been to provide a non-invasive therapy that would significantly improve Parkinson’s symptoms beyond what is currently available,” he added in a statement.
Light therapy, which can be used at home during normal evening activities, involves bathing the face in a special light. According to PhotoPharmics, the light targets photoreceptors in the eyes responsible for circadian rhythm – the day-by-day biological cycles that help many bodily functions. This means PD symptoms such as sleep disturbances, fatigue, psychological health, and cognition can be addressed with light therapy. The device is designed to be used on top of current medication.
The device has already won an FDA breakthrough device designation back in 2020, meaning PhotoPharmics is eligible for a streamlined premarket review phase.
One major advantage to the trial’s at-home and telemedicine-based format is that a broader and more diverse population can be recruited.
The number of Parkinson’s cases will grow to nearly three billion in 2029 in the seven major markets (UK, US, France, Germany, Italy, Spain, and Japan), up from from 2.4 billion cases in 2019, according to analysis by GlobalData.
PhotoPharmics’s chief science officer Dan Adams said: “As patients reported in our prior trial, this may be the first treatment that improves a broad set of functional abilities in PD when administered on top of current medication. We recently presented our new trial design to the FDA with a favourable review.”