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 devices, brought together to develop devices to lower treatment costs and provide high-value therapies for ophthalmic diseases,” Olympic Ophthalmics founder & CEO Dr. Michael Gertner said in the release. “FDA clearance is an exciting milestone for our team and more importantly, for patients. It is just the beginning of a new class of neuromodulation technologies in eye care.”
“This novel device is easy and intuitive to use by patients. It produces tears within seconds after gently touching it to the outside of the nose and pressing the ‘on’ button,” added clinical study investigator and medical director at Matossian Eye Associates Dr. Cynthia Matossian.