Olympic Ophthalmics announced today that it received FDA de novo clearance for its iTEAR100 neurostimulation technology for acute tear production.
The Issaquah, Wash.-based company’s prescription iTEAR100 system stimulates a cutaneous nerve to temporarily increase acute tear production in adults.
Olympic Ophthalmics’ neurostimulator is a stand-alone, pocket-size device that requires a 30-second-or-less application to the skin of the external nasal region. The application stimulates the trigeminal nerve to activate the parasympathetic nerve pathway that controls tear film homeostasis.
The company touted the system’s effectiveness in clinical trials and noted in a news release that the most common adverse effect observed was headache and dizziness, which occurred in 2%-3% of subjects.
“Olympic Ophthalmics is a team of entrepreneurs, clinicians, and investors with deep expertise in ophthalmology, neuromodulation, and medical d…