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TrueTear: The latest buzz
Neurostimulation produces mucin, aqueous and lipid, the elements of a complete tear.
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“It was a scratch, not a pick!”
– Jerry Seinfeld
Once in a very long time, something comes along in our eye care world and just electrifies everyone. Taking the pulse of the community finds pretty much everyone charged up about it. As if the dry eye space isn’t hot enough, along comes TrueTear to stimulate the masses.
I’ll be appearing here all night.
By this time you are doubtless aware of the Oculeve story. Young inventor Michael Ackermann translates an aha moment — when you simulate the nose by, say, a gentle tap with a boxing glove, you make tears — and creates an instrument to do just that. “Oculeve” is born after Ackerman rounds up some venture capital usual suspects. A couple of proof-of-concept demonstrations are followed by a successful trial or two, and SHAZAM, Allergan scoops up Oculeve and rebrands it TrueTear.
The science behind TrueTear
There is science here that most of us have not given a whole heck of a lot of thought to since the first year of medical school. The trigeminal nerve has three divisions. Did you remember that the first division (V1) is also called the ophthalmic nerve? Me either. V1 innervates the lacrimal gland, goblet cells and the meibomian glands, collectively referred to as the lacrimal functional unit, or LFU. V1 is further subdivided into the frontal, lacrimal and nasociliary nerves. That is the one that is famous for giving us Hutchinson’s sign of blisters on the tip of the nose in shingles. Note to Brent Saunders: The Hutchinson estate should get royalty payments.
Fifteen years ago we started to see slides depicting the circular feedback loop between the ocular surface and the brainstem. While we think of the trigeminal nerve as primarily a sensory nerve, there is both afferent (sensory) and efferent (end-organ stimulation) flow along V1. These now-famous Allergan slides show that disrupting this circular flow at the afferent end, by inflammation for example, can lead to DED. Afferent signals from the LFU and ocular surface land in the trigeminal nucleus in the brainstem and are processed in the pons. Return flow occurs across both sympathetic and parasympathetic fibers and can result in activation of all three elements of the LFU.
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TrueTear takes advantage of the fact that there are fibers of the nasociliary nerve close to the mucosal surface inside the nose. Your “target area” is just under the spot where glasses sit. The soft silicone gel tips of the TrueTear unit easily access this area. Once in contact with the inner surface of the nose, you simply press the large button in the middle of an instrument that looks kind of like one of those disposable leg shaver “egg” things, and BINGO — tears.
Does it work? You bet it does. Contrary to what most people assume, especially most people who have been punched in the nose, TrueTear produces more than just a reflex flood of aqueous tears from the lacrimal gland. In fact, the entire LFU is stimulated. What results is an increase in what can only be described as a complete tear. All three of the elements in a natural tear — mucin, aqueous and lipid — are found in essentially normal proportions in the tears that follow TrueTear stimulation of V1.
But does it really work? Is there a significant effect on DED on real, live people? Again, you bet it does. Eighty DED docs, your humble scribe included, had a chance to learn about TrueTear and give it a whirl along with some of our staff members. On its lowest of five power settings, TrueTear produced a significant flow of tears in my eyes after 5 seconds every single time. Like some 50% of people, I then went on to sneeze at 8 seconds every single time. (Allergan researchers tell us that this tends to go away with time.) I have had significant symptomatic DED for 30+ years; my eyes felt fantastic for hours after my TrueTear treatment.
Heck, Preeya Gupta has a deviated septum. She was amazed to find that she could actually breathe out of her left nostril for the first time in 15 years. (Off-label indication; very colorful personal communication.)
How it will work
TrueTear has been rolled out in what could be called a “soft release” to those 80 DED docs. It is more like an alpha trial of the business model, and it may or may not resemble what things will look like when TrueTear is widely available. Having said that, there are certain aspects of this trial that will extend into the general release. The base unit is a rechargeable instrument that will be sold as a durable medical good. Think insulin pump and you get the idea. Those silicone gel tips will then be sold by prescription in packs of 30. Each tip can be reused for 24 hours after its first “fire” for a total of 60 minutes of stimulation, more than enough to last 24 hours before it is disabled. Both instrument and tips will be eligible for insurance coverage.
It is fascinating to think about who might be in the target market for TrueTear. Obvious candidates include severe DED patients who are literally out of options and those individuals who simply cannot manipulate eye drop dispensers of any kind. What is really fun is to give a bit of free reign to your imagination for the rest. How about busy executives who spend all day in front of a screen, especially those who might wear eye makeup that would be ruined by applying artificial tears? One only has to suffer a single cross-country red eye to realize how handy a couple of TrueTear zaps might be if you have a meeting on the other end of that flight, like Laura Periman discovered. There are videos showing that prolonged stimulation can actually bring forth secretions from meibomian glands that are producing thick, semi-solid meibum. The possibilities are bounded only by our imagination.
Kind of like the possibilities to have some fun with this: bounded only by our imagination. Let’s be honest, everything about this fairly screams funny. Your eyes are dry and you need some tears, so you stick this thing up your nose and “light it up.” Can’t you just see it at those 0-dark-30 pre-dawn sessions at AAO and ASCRS? Everybody getting “buzzed” so that they can see the slides? Seinfeld gives us the obvious response when someone “catches” us using TrueTear: It’s a pulse, not a pick!
Be sure to tip your bartenders and waiters.
- For more information:
- Darrell E. White, MD, can be reached at SkyVision Centers, 2237 Crocker Road, Suite 100, Westlake, OH 44145; email: dwhite@healio.com.
Disclosure: White reports he is a consultant for Bausch + Lomb, Allergan, Shire and Eyemaginations; is on the speakers board for Bausch + Lomb, Allergan and Shire; and has a financial interest in TearScience.