Seattle start-up Olympic Ophthalmics has received US Food and Drug Administration (FDA) approval for its iTEAR100 device, a prescription neurostimulation therapy to increase tear production in adult patients over 30 days.
Applying a gentle pressure alongside the nose, the device’s vibration stimulates tear production naturally, explained the company, adding that the energy level, frequency, and tip design were optimised through clinical trials to safely and comfortably stimulate the external nasal nerve.
"Home strategies for addressing dry eye are just as important as in-office strategies,” said Dr Laura Periman, founder and director of dry eye services and clinical research at the Periman Eye Institute in Seattle. “With iTEAR100 we have seen patients attain improvements in baseline tear production, tear film stability, corneal staining and meibomian gland function, as well as symptoms — real-world data in my clinic that match data published in Translational Vision Science and Technology,” she said.
The company also announced three ongoing trials on increasing tear production in adults, including patients with newly diagnosed dry eye disease with iTEAR100 as the first treatment; a virtual telehealth trial where iTEAR100 is prescribed, monitored and titrated by a physician without the patient having to visit a clinic; and a label expansion study to optimise basal tear secretion versus reflex tearing.
Olympic Ophthalmics said its ongoing development of the platform will see the addition of further diagnostic capabilities and disease management features for a complete telehealth solution.
