Intranasal Stimulator Increases Tear Production

A noninvasive, handheld device delivers neurostimulation to the nasal cavity via disposable tips in order to increase tear production.

The TrueTear intranasal tear neurostimulator consists of a rechargeable handheld unit and disposable hydrogel tips, which are inserted into the nasal passage and used to stimulate the trigeminal nerve via the afferent ethmoid nasal pathway. The neurostimulation device allows dry eye patients not only to treat themselves by activating their own tear production system, but also to activate other glands that secrete lipids and proteins, thus increasing the mucin and aqueous layers of the tear film.

Two clinical studies involving 145 aqueous deficient dry eye adult patients showed positive safety and effectiveness of the device in the increase of tear production. The direct clinical benefit of temporarily increasing tear production as a therapy for dry eye disease was not assessed as part of the clinical trials, but all device-related adverse events were mild in nature. The TrueTear intranasal tear neurostimulator is a product of Allergan, and has been approved by the U.S. Food and Drug Administration (FDA).

“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.”

“In clinical trials, TrueTear demonstrated increased tear production upon stimulation of the nasal cavity,” said professor of ophthalmology John Sheppard, MD, MSc, of Eastern Virginia Medical School (Norfolk, USA). “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.”

Of more than 100 million dry eye sufferers worldwide, about 80% suffer from evaporative dry eye, caused by meibomian gland dysfunction (MGD) and a lipid deficiency of the eye’s natural tear film. The condition leaves patients with too few tears, making the remaining ones feel too salty. Symptoms of evaporative dry eye disease include eye irritation, dryness, redness, tiredness, and visual disturbances.