FDA grants novel clearance for tear neurostimulator
Olympic Ophthalmics received FDA de novo request clearance for its iTEAR100, an external prescription device designed to temporarily increase acute tear production in adults by stimulating a cutaneous nerve.
De novo request clearance is provided to novel medical products with low to moderate risk that do not qualify for 510(k) clearance due to the lack of an existing device of substantial equivalence on the market.
“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,” Cynthia A. Matossian, MD, FACS, an investigator in the clinical studies and medical director at Matossian Eye Associates, said in a press release from Olympic.
Use of the stand-alone, pocket-sized device requires approximately 30 seconds or less of application to the skin of the external nasal region. The device stimulates the trigeminal nerve, activating the parasympathetic nerve pathway that controls tear film homeostasis, according to the release.
Results from clinical trials showed the device to be well-tolerated and effective at temporarily increasing tear production. The most common adverse effect was headache and dizziness in 2% to 3% of participants, the company said.