FDA grants De Novo request for the non-drug, external neurostimulator to temporarily increase acute tear production.
Press Release – updated: May 14, 2020 06:00 EDT
ISSAQUAH, Wash., May 14, 2020 (Newswire.com) –
Olympic Ophthalmics announced today that the U.S. Food and Drug Administration (FDA) has granted a De Novo request (DEN 190006) for iTEAR100®, a prescription neurostimulation technology to temporarily increase acute tear production in adults. Stimulating a cutaneous nerve, iTEAR100® is an external neurostimulator approved to increase acute tear production.
The iTEAR100® Neurostimulator is a stand-alone, pocket-size device requiring only a 30 second or less application to the skin of the external nasal region. Its application stimulates the trigeminal nerve, which results in activation of the parasympathetic nerve pathway that controls tear film homeostasis. Demonstrated in trials to be well tolerated and effective at temporarily increasing acute tear production, the iTEAR100® is a cost-effective option. It will be supplied through eye care provider channels for adults who would benefit from increased production of tears. The most common adverse effect in clinical trials was headache and dizziness in 2-3% 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,” shared 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.”
“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,” said Dr. Cynthia Matossian, an investigator in the clinical studies and Medical Director at Matossian Eye Associates, an affiliate of Prism Vision Group.
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. These data will be presented by Laura Periman, MD at the American Society for Cataract and Refractive Surgery (virtual) meeting on May 18, 2020.
About Olympic Ophthalmics, Inc.
Olympic Ophthalmics, Inc. is a medical technology company pioneering simple, high-value treatments for ophthalmic diseases through neuromodulation. The company is based in Issaquah, Washington and backed by lead venture capital investor BioStar Capital.
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Source: Olympic Ophthalmics