ISSAQUAH, WA — Olympic Ophthalmics announced that the U.S. Food and Drug Administration has approved its prescription neurostimulation technology to temporarily increase acute tear production in adults.
The technology, called iTEAR100, is an external neurostimulator approved to increase acute tear production.
The neurostimulator is a standalone, pocket-size device requiring only a 30-second or less application to the skin of the external nasal region. It was approved via a “de novo” request to the FDA.
“Its application stimulates the trigeminal nerve, which results in activation of the parasympathetic nerve pathway that controls tear film homeostasis,” according to a press release from Olympic Ophthalmics.
The neurostimulator was stated to be well tolerated and effective at temporarily increasing acute tear production, the company stated. It will be supplied through eye care provider channels for adults who would benefit from increased production of tears. The most common adverse effects in clinical trials were headache and dizziness in 2 percent to 3 percent 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,” said Dr. Michael Gertner, founder and CEO. “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.”
The device “is easy and intuitive to use by patients,” said Dr. Cynthia Matossian, an investigator in the clinical studies and medical director at Matossian Eye Associates, an affiliate of Prism Vision Group. “It produces tears within seconds after gently touching it to the outside of the nose and pressing the ‘on’ button.”
FDA reviewed results from two pivotal studies, one of which was a double-masked, randomized, sham-controlled multi-center study and the second, a multi-center six-month single-arm study in which subjects used the stimulator twice per day.