Olympic Ophthalmics Gets FDA Clearance for its iTEAR100 Neurostimulation Device

Olympic Ophthalmics has been granted 510(K) clearance by the FDA for its second-generation iTEAR100 device, a prescription neuromodulation therapy to increase tear production.

The device features telehealth tools, including prescription-download capability and activation through a mobile phone app, according to the Issaquah, Wash.-based company.

Olympic Ophthalmics is conducting three clinical trials of the iTEAR100, including a study in patients with newly diagnosed dry eye disease who are using iTEAR100 as their first treatment; a virtual telehealth trial where iTEAR100 is prescribed, monitored and titrated by a physician without the patient having to visit a doctor’s office; and a label expansion study to optimize basal tear secretion vs. reflex tearing.