Olympic’s tear stimulator receives US FDA clearanceJune 10, 2020
Olympic Ophthalmics announced that the US FDA has granted a De Novo request 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 standalone, pocket-size device requiring only a 30 second or shorter application to the skin of the external nasal region. Its application stimulates the trigeminal nerve, which results in the 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.