US medical technology company Olympic Ophthalmics has secured clearance from the US Food and Drug Administration for its iTEAR100 Neurostimulator.
iTEAR100 is an external neurostimulator which has been granted a De Novo request by the FDA to temporarily increase acute tear production in adults by stimulating a cutaneous nerve.
Dr Cynthia Matossian, an investigator in the clinical studies and Medical Director at Matossian Eye Associates 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”.
The iTEAR Neurostimulator is a pocket-size device that stimulates the trigeminal nerve with the application to the skin on the external nasal region for around 30 seconds or less. The stimulation of the trigeminal nerve leads to the activation of the parasympathetic nerve pathway that controls tear film homeostasis.
The external neurostimulator has been found to be well-tolerated and effective in clinical trials in temporarily increasing acute tear production.
According to Olympic Ophthalmics, the FDA approved the iTEAR100 Neurostimulator based on the findings of a couple of clinical studies. Included in these are a double-masked, randomized, sham-controlled multi-center study and a multi-center single-arm study in which subjects used the stimulator two times a day.
Dr Michael Gertner – Olympic Ophthalmics Founder and CEO said: “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.”