PhotoPharmics has announced a pivotal development in its FDA “Light for PD” clinical trial of the Celeste therapeutic device, with the first subject completing the full six-month treatment course, designed to treat Parkinson’s disease (PD).
This is a significant step towards the potential FDA authorisation of Celeste, a non-invasive phototherapy device.
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The trial is designed to demonstrate the efficacy and safety of the device in treating the neurological disorder affecting more than 11 million people worldwide.
PD is characterised by the degeneration of dopamine-producing neurons, leading to symptoms such as rigidity, tremors and cognitive decline.
Celeste employs non-invasive phototherapy to deliver specialised wavelengths of light to neurons in the eye, which may signal brain areas involved in sleep, wakefulness, mood, and energy.
This method is similar to how Parkinson’s medications enhance damaged motor signalling in the brain, but Celeste focuses on stimulating the eye’s impaired photoreceptor signalling.
PhotoPharmics CEO Kent Savage said: “This marks significant progress for this groundbreaking study. While it is too early to know results, we are optimistic that the Celeste device can represent a significant advancement in treating Parkinson’s.”
The trial involves subjects receiving daily phototherapy sessions for a six-month duration.
Carried out remotely in the US, it provides data which will be vital in assessing the safety and efficacy of the Celeste device.
PhotoPharmics science officer Dan Adams said: “We believe Celeste could address both the motor and non-motor symptoms of PD beyond current medical care, offering a simple, passive treatment option.”
Phototherapy has been used to treat conditions such as certain skin issues and seasonal affective disorder (SAD) but its application to neurological disorders such as PD is a new approach.
In May 2024, PhotoPharmics announced the enrolment of first patients with PD in a study, which seeks to validate the effectiveness of phototherapy in improving symptoms of the disease.
