iTEAR100 is a pocket-size device that activates the parasympathetic nerve pathway that controls tear film homeostasis
Olympic Ophthalmics gets FDA npd for iTEAR100 neurostimulator device. (Credit: Pixabay.)
US-based medical technology company Olympic Ophthalmics has secured the US Food and Drug Administration (FDA) De Novo approval for its iTEAR100, a prescription neurostimulation technology.
iTEAR100 is an external neurostimulator that has been approved to increase acute tear production in adults by stimulating a cutaneous nerve.
Clinical studies investigator Cynthia Matossian said: “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.”
iTEAR100 Neurostimulator is a pocket-size device that stimulates the trigeminal nerve
The iTEAR100 Neurostimulator is a pocket-size device that stimulates the trigeminal nerve through application to the skin of the external nasal region, for only a 30 second or less.
The device is said to be a cost-effective option that activates the parasympathetic nerve pathway that controls tear film homeostasis. It has been well tolerated and effectively increased the temporary acute tear production, in clinical trials.
To be supplied through eye care provider channels, the device will enable adults to benefit from increased production of tears. The most common adverse effect in clinical trials was headache and dizziness.
FDA carried out a review on results from two clinical studies, which include a double-masked, randomised, sham-controlled multi-center study and a multi-center single-arm study.
Olympic Ophthalmics is enagaged in providing simple, high-value treatments for ophthalmic diseases through neuromodulation.
Olympic Ophthalmics founder and CEO Michael Gertner “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.
“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.”