Claims aplenty despite lack of demonstrated clinical benefit from Allergan’s new device for dry eyes

Allergan Granted Marketing Authorization by the FDA for TrueTear™, the First Intranasal Neurostimulating Device Proven to Temporarily Increase Tear Production

Our Review Summary

Even though this news release about the first FDA-approved neurostimulator intended to increase tear production in patients with dry eye is carefully worded, it glosses over key points and leaves out useful information and context.

It says primary endpoints were met, without explaining precisely what those endpoints were. It reports the total number of patients in two trials (145), but not how many were in each one or whether any dropped out or had unsatisfactory results. It does not mention that one trial involved just a one-day test in which some patients compared the device to a sham device. It includes a quote that calls the device a “technological breakthrough,” even though there have not been any trials comparing the device to existing treatments. Another quote from a university professor fails to note that he receives consulting and speaking payments from the company.

 

Why This Matters

Dry eyes can result from a number of diseases, medications, use of contact lenses, and aging. It is a fairly common condition (with a prevalence of about 14 percent) and in serious cases, dry eyes can cause pain and blurred vision, and increase the risk for infection, inflammation, and ulcers of the corneas.

But this release doesn’t satisfactorily explain how patients benefit from the neurostimulator device.

It does underscore the importance of Clinicaltrials.gov and PubMed. These federal websites provide information about human clinical trials and follows up with published research results. The news release referred to two studies, but left out useful information. Searches of the public websites revealed that one of the studies lasted just a single day, and that there have been other trials of the device that were not mentioned in the release.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

Even though this tear stimulator has been approved for sale, no price is mentioned in the release. After an internet search on costs we came up empty-handed. A specialized device like this is expected to cost a few to several hundred dollars. Will it be covered by insurance plans? The release doesn’t say.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The release discloses that “direct clinical benefit of temporarily increasing tear production as a therapy for patients with dry eye disease was not assessed.” That is, we don’t know if patients will see actual benefits from the device.

But other claims were made. The release says that the device temporarily increases tear production, but not by how much or for how long. The section describing the results of two studies manages to avoid providing any actual results. It says that primary effectiveness endpoints were met, but nowhere does it say what those endpoints are. The release also fails to say how many of the study participants had more tear production using the neurostimulator.

Dry eyes is a chronic problem, and we don’t know from the release if the device helped prevent consequences of drug eyes including pain and damage to the cornea that may occur. Does tear production occur just at the time of stimulation (a few seconds) or if it lasts throughout the day. For example, would people have to use the device every hour? This remains unknown at this time because such studies were not done, nor were they required to gain FDA marketing approval.

Does the news release adequately explain/quantify the harms of the intervention?

Satisfactory

We will give the release a satisfactory rating because it includes a list of adverse events and warns that there is no long term safety data. But the side effects are described only in percentages and there is no indication of the severity of the events. Other reports about the device indicate that the news release left out information about adverse events seen in other trials, as well as speculation about potential long term effects.

An article published in Clinical Ophthalmology, which describes an experiment that appears to be a precursor to “Study 2” in the news release, describes three device-related adverse events, including one migraine headache in a patient with a history of migraines, along with two cases of nasal discomfort that lasted a day or two.

An article written by a doctor who said he tested the device reports that “The exact mechanism of action of OD-01 is still under investigation, because there is some suggestion that the device may produce long-term effects. One proposed mechanism is that neurostimulation works to kick-start the system through some form of lacrimal gland remodeling.” Well, if use of the device could cause long term effects, including changes to the glands that produce tears, the release should have mentioned that potential.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

While the news release includes a basic description of two studies, it leaves out key information, including the number of study participants in each trial (giving only a total of 145 patients for both trials) and what their Schirmer scores were. (The Schirmer test involves putting a piece of paper under a patient’s eyelid to soak up moisture.)

The release also makes no mention of results from two other trials of the device that are listed on Clinicaltrials.gov, which means readers have no way of knowing if these other trials produced results similar to the ones that the company included.

What’s more, the article published in Clinical Ophthalmology mentioned above appears to be a precursor of the “Study 2” mentioned in the release. It took place in Mexico two years before the six-month device trial listed on Clinicaltrials.gov.

So it appears that the company included results from only some of the studies they have performed.

As noted above, no actual clinical endpoints are evaluated meaning we can’t know whether the device will help alleviate pain, blurring of vision, or corneal problems caused by dry eyes.

Does the news release commit disease-mongering?

Not Applicable

The news release doesn’t engage in disease mongering, but it doesn’t provide any context about dry eye either.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

Although readers will assume that Allergan (and Oculeve, which first developed the device before it was bought by Allergan) funded the studies, the release includes a quote from a university professor without disclosing that he serves as an advisor or consultant to Allergan and makes paid speeches on behalf of the company. (See “Faculty and Disclosures” link in this Medscape CME article.)

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

The news release includes quotes calling the device a breakthrough and touting its superiority to other dry eye treatments, without clearly noting that neither of the studies mentioned in the release compared the device to other treatments.

It also doesn’t name any alternative treatments now in use, including artificial tears, and immunosuppresant drugs and tear duct plugs.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

The release says that the device has been granted marketing authorization by the FDA. One can safely assume the product will be on the market by the end of the year.

Does the news release establish the true novelty of the approach?

Satisfactory

The release says this is the first neurostimulator intended to increase tear production in patients with dry eye problems.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Not Satisfactory

As noted above, the release includes a quote calling the device a breakthrough. This language seems premature for a device that has been tested in only 145 patients for at most six months (and many of those patients tried the device on only a single day), and before any trials have been done that compare the device to existing treatments.

Total Score: 3 of 9 Satisfactory

Comments (2)

Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.

Venkat Neelakantan

August 29, 2017 at 8:17 am

Excellent analysis of the new device.

Reply

Gail Honadle

October 11, 2018 at 2:34 pm

Excellent analysis of this Tens unit. Considering this is nothing but a fancy Tens unit you stick up your nose and have to buy replacement elements that go in the nose, I don’t see how it can open Meibomian Glands which is what it is supposed to do. Nose Bleeds, face Pain, didn’t see that mentioned. Can’t be used with other implanted Devices like Pace Maker, Chochelar Implants, Why didn’t they use Sjorgen’s Syndrome Patients to test it on as Dry Eye Syndrome is one of their health issues? 145 People is not a sufficient pool of test subjects, what disease did they have that caused Dry Eye or where they just Computer people who spend 8 hrs a day on the computer. My Cornea doc is trying to sell me this $1,000 Tens unit. Just clean the glands open. A sock filled with 2 lbs of Rice heated in the Microwave 60 seconds add a wet cloth to create moisture, will help open the Glands. Keeping them open is a issue for Sjorgen’s patients. My drain ducts are already cauterized closed. Both Cataract and Lasix to fix the badly down one left me with permanent Dry Eye. And those Lubricant drops don’t last much longer than my tear film. 3-5 seconds. Health ins doesn’t cover the cost either! Totally out of Pocket.

Reply