FDA grants clearance for iTEAR100 neurostimulation device
Olympic Ophthalmics announced that the FDA granted the 510(K) request for its second-generation iTEAR100 device, a neuromodulation therapy that improves tear production in 30 days in adults.
The device provides telehealth tools, such as prescription download capabilities and activation, to patients via a mobile app, the company said in a press release.
Olympics Ophthalmics also announced three ongoing, phase 4 trials, which aim to assess iTEAR100 as the initial treatment in patients newly diagnosed with dry eye disease and further examine the device’s telehealth capabilities and customizable treatment tiers.
New innovations for the device also are underway, including additional diagnostic capabilities and disease management features.
“We recently introduced the iTEAR100 as a natural, chemical-free neurostimulation option, which patients have been thrilled with,” Kambiz Silani, OD, chief clinical director at the Advanced Dry Eye Center at Beverly Hills Optometry, said in the release. “In just a few minutes, we are able to demonstrate how the technology works, as well as allow the patients to practice using the device in office before prescribing it to use daily, safely and comfortably on their own.”
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