This is a lay-friendly news release touting the b
enefits of lifitegrast (marketed as Xiidra), a newly approved prescription drug for the treatment of dry eye. It would have been stronger with some quantified details on the benefits and a better description of the clinical trials the drug’s recent FDA approval is based on. Although this is not the only product available for treatment of dry eye, the news release does not say anything about the others while claiming that this is the first prescription drug for dry eye. And there was no mention of the cost of the product. As a result, a reader does not have enough information to formulate an informed opinion about the product.
Though dry eye rarely results in permanent vision loss, it can lead to “pain, ulcers, or scars on the cornea, and some loss of vision,” according to the National Eye Institute.
Dry eye can also make it difficult to use a computer or read. Thus, treatments can be key to improving quality of life.
The drug’s approval is a significant boon for Shire, the manufacturer. Analysts predict it may become a blockbuster (meaning sales in excess of $1 billion) by 2022. With such a potentially wide customer base, claims about its benefits — particularly in relationship to other available over-the-counter and prescriptions treatment options — should be carefully scrutinized.
The news release does not mention cost. We were unable to find any cost information online after a brief Google search.
The benefits were summarized this way: “In all four studies, eye dryness was significantly reduced, with two of the studies showing improvements at week two. Results from inferior corneal staining tests — used by physicians to detect abrasions on the cornea — showed improvement in three of the four studies.”
How was eye dryness measured? How reduced was “significantly reduced?” How was “improvement” of abrasions measured? How improved was the improvement?
The news release does not say.
No mention is made of possible harms caused by the drug. But the package insert for the drug, also known as Xiidra, notes that they exist: “The most common side effects of Xiidra include eye irritation, discomfort, or blurred vision when the drops are applied to the eyes, and an unusual taste sensation (dysgeusia).” It appears that some of the side effects are the same as the symptoms that the drug is supposed to relieve.
The news release describes the trials that the FDA looked at: “Nichols and a team of researchers studied 1,181 patients, of whom 1,067 received lifitegrast in four placebo-controlled 12-week trials. Signs and symptoms were assessed at baseline and at weeks two, six and 12.”
The release would have been more helpful if it had noted whether the studies were blinded since this could be a significant factor in determining the outcome (redness), something that would be subjective and could be influenced by whether researchers knew who was getting the drug or placebo.
An astute reader who followed up and looked up the studies (found at http://www.shiretrials.com/en/studies, choose “Dry Eye Syndrome” from the drop down menu) would find that in one of four trials the drug was no better than placebo in reducing corneal abrasions. In general, the descriptions of the trials were superficial with only the term “placebo” giving us any information about how they were set up. Since there are other remedies for dry eye available, why weren’t they — instead of placebo — studied against this new drug?
Optometrist Kelly Nichols is quoted as saying, “There is hope for dry eye patients worldwide.” Given that dry eye is not fatal and rarely results in permanent vision loss, that statement might be considered hyperbolic.
The news release also states, without attribution, that dry eye affects more than 16 million adults in the United States.
A search of the National Eye Institute’s website finds no total figure for U.S. adults, but the figures it does offer raise questions about whether the 16 million figure is accurate: “Elderly people frequently experience dryness of the eyes, but dry eye can occur at any age. Nearly five million Americans 50 years of age and older are estimated to have dry eye. Of these, more than three million are women and more than one and a half million are men. Tens of millions more have less severe symptoms. Dry eye is more common after menopause. Women who experience menopause prematurely are more likely to have eye surface damage from dry eye.”
There is a small risk that the release, when encouraging patients to visit the specific eye clinic at UAB, could lead to “indication creep” as more and more people with very mild symptoms go to that clinic for diagnosis and treatment.
The news release acknowledges that the person quoted was doing work for Shire plc, the company that makes the product. The release was correct to include this funder as a potential conflict of interest. It would also have been good to note that study was conducted by by the UAB Center for Translational Research.
The news release notes that researchers are working to find new treatments for dry eye, with more than 30 studies under way. But it makes no mention of the currently available treatments or how this product compares with them.
Other available treatments including artificial tears; Restasis, a drop that that induces tear production; and there are many other eye drops on the market that treat some of the side effects of eye dryness.
Though the news release does not say anything about availability, it does note that the FDA has approved the product. The drug was approved July 12, 2016.
The news release claims that the product “is the only prescription eye drop indicated for the treatment of both signs and symptoms of dry eye, and it is the first new dry eye prescription drop approved in the last 13 years.” That’s partly true, as the fact-checking site PolitiFact might say.
There are other prescription and over-the-counter eye drops available for treating the signs and symptoms of dry eye. Restasis, a drug that stimulates tear production, was approved in 2003, so the claim that Xiidra is the first prescription drug “approved in the last 13 years” for dry eye is true, to our knowledge.
The news release body does not engage in unjustifiable language. However, the headline says that a “UAB Optometrist improves treatment and care for patients with dry eye.” Though that may well be true, the news release does not offer evidence to support that assertion. We rate this a borderline satisfactory.
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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