This designation is given to medical devices with the potential to offer more effective treatment for life-threatening or debilitating diseases. It grants the company access to experts at the FDA during development, and paves the way for prioritized review of approval requests.
In addition to its motor symptoms, Parkinson’s is characterized by non-motor symptoms that can occur several years before difficulties with movement and muscle control begin to emerge. These include cognitive impairment, sleep disturbances, depression, and pain.
The circadian rhythm — our body’s “natural clock” that regulates essential functions such as sleep or metabolism — is known to be poorly regulated in people with Parkinson’s. That dysregulation is associated with the development of both motor and non-motor disease symptoms.
PhotoPharmics’s device is based around light therapy, or phototherapy, and uses a combination of light intensities and bandwidths believed to have therapeutic effect. Preclinical work suggests that light therapy can improve the circadian rhythm, and help ease disease symptoms.
A clinical trial (NCT02175472), sponsored by PhotoPharmics, treated 92 Parkinson’s patients — ages 45 or older, and all on stable dopaminergic therapy — with either its light therapy device or a placebo light for one hour each evening for six months.
Results, released in late 2018 and based on scores reported by both patients and doctors, showed an easing in disease severity, lesser non-motor symptoms, and improved quality of life among those given the light therapy.
“Very few device companies receive Breakthrough designation. Our device is the first specialized phototherapy device ever to achieve this status,” Kent Savage, PhotoPharmics’s chief executive officer, said in a press release. “We believe this is largely due to the improvements we saw in non-motor symptoms” in this trial.
“Since there is no known cure for Parkinson’s disease, our mission is to help people recover function and return to what they enjoy doing most. This recognition … validates our work,” Savage added.
PhotoPharmics is currently engaged in a financing round to support a planned pivotal clinical trial of its Celeste phototherapy device (based on its Spectramax technology) in treating Parkinson’s.
The proposed Phase 3 trial is expected to begin enrollment of up to 200 patients in August. Those interested in participating, or in learning more about the company and this device, can sign up for information on its website.
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