Nasal Neurostimulating Device to Treat Dry Eye Syndrome

TrueTear dry eyes

You don’t have to be sad to have tears in your eyes. Your eyes always have tears in them to provide moisture and lubrication to help you see and keep them comfortable. However, some people have dry eyes which create too many tears. Dry eye syndrome is caused by a chronic lack of sufficient lubrication and moisture on the surface of the eye. Dry eyes are very common, and dry eye syndrome is a major reason for visits to the eye doctor.

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Irish pharmaceutical company Allergen has developed TrueTear®, a device to temporarily increase tear production during neurostimulation in adult patients. The FDA-cleared device consists of a handheld neurostimulation device with a disposable tip that is inserted into the nasal cavity to induce the production of natural tears, providing a novel and innovative approach for patients with inadequate tear production to improve dry eye symptoms in adult patients with severe dry eye symptoms, reports Flex.

Allergen has now teamed up with Flex, a Sketch-to-Scale® solutions provider that designs and builds Intelligent Products for a Connected World, to market the product.

TrueTear dry eyes

“Flex forged a very strong working relationship with the members of our team. With great people who are willing to work together, they made the difference and stretched to produce this innovative product,” said Chris Stivers, Program Lead, Manufacturing, Allergan.

Flex worked with Allergan and provided their Sketch-to-Scale solution that incorporated Design for Reliability (DfR), Design for Manufacturing (DfM), and new product introduction expertise. The company collaborated with the Allergan team to develop the product, usher it through FDA clearance, and scale manufacturing to bring the device to market.

On the development side, it was necessary to manage the unique hydration process essential to maintain the right moisture level for TrueTear. Flex designed the device’s fluid dispenser automation, the equipment for trays and sleeve, and the disposable tip; key to delivering the electrical pulses.

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After receiving FDA clearance in April 2017, TrueTear was introduced to ophthalmologists and is now being produced in Flex’s Gushu, China facility.