TrueTear granted marketing authorisation by the FDA

26th April 2017

Allergan plc

Enaie Azambuja

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Allergan plc has announced that it has been granted marketing authorisation from the U.S. 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.

"In clinical trials, TrueTear demonstrated increased tear production upon stimulation of the nasal cavity," said John Sheppard, M.D., M.M. Sc., professor of Ophthalmology, Eastern Virginia Medical School and president of Virginia Eye Consultants.

"Interestingly, neurostimulation has been used as an approach for a wide variety of disorders for more than 30 years. TrueTear is the first of its kind to provide a temporary increase in tear production in this way."