Nasal stimulation for aqueous deficiency-induced dry eyes

Periodically, I bring you new treatment paradigms for the conditions we encounter in our patients — this time it’s one for dry eye. While dry eye treatment is focused on pharmacologically based regimens, including tear supplements, anti-inflammatory agents, Omega-3 nutraceuticals and care for lid margin disease, we will soon have widespread access to a first of its kind — a device-centric, nasal stimulation treatment.

Neural stimulation is not new; already, patients have access to FDA-approved devices that attempt to treat conditions including sleep apnea, obesity, epilepsy, depression and migraine. Its application to dry eye started: as a Stanford Medicine biodesign program; was further developed by Oculeve; and then acquired by Allergan. The common denominator here is Michael Ackermann, PhD, who helped develop TrueTear at Stanford and now serves as the vice president of neurostimulation at Allergan.

The proprietary device has been “soft released” to 80 ophthalmologists nationwide, including our practice, to understand how it will be received by physicians and patients.

THE PHYSIOLOGY

The TrueTear, (formerly known as Oculeve,) is a rechargeable, Bluetooth-ready unit about the size of a box of Tic Tacs, with a pair of soft, silicone-tipped prongs on the end. Following a complete charge, which lasts several days to a week depending on the frequency of use, the patient presses the button to activate the device, sets the power level (it is recommended to start at level 2 of 5) and inserts the prongs as high up in the nose as possible, pressing slightly outward to reach the terminal fibers of the trigeminal nerve, inside the nose.

A pulsing sensation is detected by the patient, and within seconds the eyes begin to tear; the ocular results are near immediate and remarkable, capable of addressing both evaporative and aqueous deficient dry eye. The unit shuts itself off automatically. The patient can use TrueTear as many times daily as she wants, though the prongs are only functional for 24 hours, after which a new tip must be “clicked” into place.

So why does “sticking something up your nose” produce tearing, and what quality of tears does this maneuver yield? Remember that the trigeminal nerve has three divisions, the first of which is the ophthalmic nerve (V1). The branches of V1 innervate the lacrimal gland, meibomian glands and the goblet cells on the ocular surface. Because there are afferent (sensory) and efferent (stimulatory) elements, stimulation of the trigeminal nerve brings end-organ signals to all three major components of our tear film.

What is particularly interesting is that these tears have components of the lacrimal gland, goblet cells and meibomian glands, and some patients report that the tearing effect can last for hours. The tears are moist and comfortable, and do not run down the cheek.

THE DATA

A 2016 study of the TrueTear found it to be a safe and effective means of reducing dry eye symptoms in DED patients.¹

The study followed a six-month at-home trial, during which the patients were instructed to use the device four times daily, and subjects were examined at days 7, 14, 30, 90 and 180. “Schirmer scores measured during intranasal stimulation showed a robust increase relative to the corresponding nonstimulated Schirmer scores at all time points,” according to the study’s authors. The outcomes for the study’s secondary clinical endpoint, ocular surface staining, is “promising” and warrants further investigation.

The authors report three adverse events, including one migraine headache in a subject with a history of migraine and mild nasal discomfort.

FEELING IS BELIEVING

Skeptical, I tried this device at the ASCRS meeting in Los Angeles and was amazed with the result. It’s a surprising sensation, best described as a tickle. The learning curve is brief, and within five seconds my eyes welled up with tears. We have a demo unit and demo tips in the office, so patients can experience this tearing reflex, with the help of a technician. At that point, they can either buy the device from your office or, if you choose not to purchase units to sell, the staff can order the unit and tips for the patient from Allergan. Allergan hopes to receive insurance coverage for the TrueTear. In the meantime, a rebate is sent to the patient to offset its cost.

Do not use the TrueTear in the presence of a cardiac pacemaker, implanted or wearable defibrillator, or other metallic or electronic implanted device. Recurring or chronic nose bleeds may be a contraindication for the treatment.

CONCLUSION

It is uncommon for a truly novel treatment paradigm for DED to emerge. While patients may “push back” when asked to spend a few hundred dollars on treatment as they do for other dry eye treatments, I find that symptom severity often compels patients to try new methods of healing. I strongly suggest that you demonstrate this device with your rep when available, or at the next national meeting you attend. If you have dry eyes, you may be your first customer! OM

REFERENCE

1. Friedman NJ, Butron K, Robledo N, et al. A nonrandomized, open-label study to evaluate the effect of nasal stimulation on tear production in subjects with dry eye disease. Clinic Ophthalmol. 2016; 10:795-804.

Steven M. Silverstein, MD, FACS, is a corneatrained comprehensive ophthalmologist in practice at Silverstein Eye Centers in Kansas City, Mo. He invites comments. His e-mail is ssilverstein@silversteineyecenters.com.