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Allergan Granted Marketing Authorization by the FDA for TrueTear™, the First Intranasal Neurostimulating Device Proven to Temporarily Increase Tear Production

26 Apr 17

Allergan plc, today announced that it has been granted marketing authorization from the U.S. Food and Drug Administration (FDA) for TrueTear™ Intranasal Tear Neurostimulator, the first and only FDA-cleared device developed to temporarily increase tear production during neurostimulation in adult patients.

TrueTear™ is a handheld stimulator with daily disposable tips that is inserted into the nasal cavity to induce the production of tears. There have been two clinical studies showing positive safety and effectiveness of the device in the increase of tear production completed with 145 aqueous deficient dry eye adult patients. 

"TrueTear™ represents a technological breakthrough for eye care professionals as it delivers an effective, non-invasive and drug-free way to temporarily increase tear production," said David Nicholson, Chief R&D Officer, at Allergan. "As an innovator in eye care, we are continually looking for new products to offer through our portfolio, and TrueTear™ represents the next step forward."

The new advancement is an addition to Allergan's current eye care portfolio. Last May, Allergan announced positive results from two pivotal trials for TrueTear™ that showed an increase in tear production upon nasal neurostimulation in adults with aqueous tear deficiency. 

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