ARTICLE SUMMARY:
The company is developing the first light-based, at-home device used as an add-on therapy for increasingly prevalent Parkinson’s disease to receive a 510(k) de novo classification and Breakthrough Device designation from FDA. Importantly in light of the COVID-19 pandemic, its upcoming Phase III trial will be remote, and then the next hurdle will be EU MDR.
PhotoPharmics Inc. is literally shining light on an increasingly prevalent neurodegenerative disease with no cure, and few treatment options: Parkinson’s disease (PD). The company, founded in 2011 and headquartered near Salt Lake City, UT, is the first with a specialized, home-use phototherapy device to receive the FDA Breakthrough Device Designation, this April, after the firm submitted a de novo classification marketing application in 2018. The company has a Phase III trial scheduled to begin enrollment this August, following FDA’s request for additional efficacy data after a Phase II study narrowly missed its primary endpoint. Parallel to this, it is pursuing a European market strategy on the go-to-market version of its device, Celeste, and working through the challenging MDR certification and CE mark processes.
