Allergan’s tear-boosting neurostimulator gets FDA OK

The TrueTear device is a noninvasive, drug-free way to temporarily increase tear production in adult patients. (Allergan)

The FDA granted Allergan marketing authorization for its intranasal tear stimulator, which temporarily increases tear production in adult patients.

People with dry eye disease either do not produce enough tears or produce poor-quality tears. Allergan’s hand-held device, picked up in the company’s 2015 acquisition of Oculeve, delivers neurostimulation via disposable tips that are inserted into the nasal cavity, according to a statement. It is a noninvasive, drug-free addition to Allergan’s eye care offerings.

"In clinical trials, TrueTear demonstrated increased tear production upon stimulation of the nasal cavity," said John Sheppard, M.D., a professor of ophthalmology at Eastern Virginia Medical School, in the statement.

The pharma announced that the device met primary and secondary endpoints of increased tear production measured by Schirmer score in a pair of pivotal trials last May. While these studies did not evaluate the direct clinical benefit of the treatment for patients with dry eye disease, two clinical studies showed it was safe and effective in increasing tear production in 145 adults with aqueous-deficient dry eye disease, Allergan said.

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In November, the company bagged an FDA clearance for another eye treatment: its Xen Glaucoma Treatment System, acquired in its $300 million AqueSys buy. The gel stent and injector combination is an alternative for patients with refractory glaucoma for whom surgery and drugs have failed.

The width of a human hair, the Xen45 stent is made of collagen-derived gelatin and is implanted with a preloaded injector through the cornea. The stent creates a channel through which aqueous humor can drain, relieving pressure in the eye.