This release reports on the results of a phase 3 trial of a cyclosporine A ophthalmic solution (trade name Seciera) intended to treat dry eye symptoms. The release states that the randomized, controlled trial involved 744 patient volunteers, which suggests good evidence, but the release omits information from the study that would be useful to journalists and the public. It provides no numerical data on the results of the trial, only vague statements, and doesn’t explain any potential harms of the medication. No information is given on where the study was conducted, or information to rule out conflicts of interest. In essence, this release seems more interested in establishing a foothold in what is seen as a growing commercial market than it is in explaining the actual research,
There’s no question that having dry eyes is at least a nuisance and at worst a clinical problem needing a solution, but it is clearly not a disease. Dry eyes can be a side effect of some medications or surgical procedures, a symptom of some diseases, and a condition affecting older individuals. Unfortunately, labeling it as a disease as this release does places an artificial urgency on the need for products to treat it, thereby profiting its manufacturer more than aiding the public.
There is no mention of the cost of this new product, nor is there any information on its needed frequency of use, which would be helpful to consumers considering it versus other products intended to curb dry eye symptoms. Another prescription cyclosporine ophthalmic product for dry eyes already on the market averages more than $400 for a one month supply (60 vials of Restasis 0.4ml).
The release doesn’t provide any quantification of the results of this trial, instead it offers vague terms such as “showed statistically significant improvement in the primary end point,” and “showed statistically significant improvements compared to vehicle.” It also offers, “Based on published data, the efficacy and safety endpoints in these trials compared favorably to other formulations of cyclosporine A with the advantage of early onset,” a statement which also provides no numerical information for readers.
While the release does acknowledge harms by saying, “Adverse events reported in the trial were mild to moderate in nature and similar to other approved drugs in the category,” that offers no useful information for readers as to what those adverse events are, or how troublesome they might be to those using the product. The U.S. National Library of Medicine lists these possible side effects from cyclosporine ophthalmic: “burning, itching, stinging, redness, or pain of the eyes, overflow of tears, red eyes.eye discharge, blurred vision or other vision changes, feeling that something is in the eye.”
The release describes the study protocol as a “12 week, multicenter, randomized, double-masked, vehicle controlled Phase 3 confirmatory study, 744 dry eye patients were treated either with Seciera™, or its vehicle.”
This release steps over the line in this category by referring to “dry eye disease.” Dry eyes are a condition that plague some individuals due to aging or changes in hormones; it may be a symptom of other ailments or a side effect of some medications or procedures, such as Lasik surgery. But calling the dry eye condition a disease suggests the need for a cure and therefore pushes the idea that a new product might solve that situation. Furthermore, the release itself reinforces that by having one of the product’s company officials discuss the “rapidly growing, underserved, and dynamic Dry Eye market, which is expected to reach $5 billion by 2020.”
There is no mention in the release of who funded the study. Also, there is no information about where the study was conducted, or which institutions were involved, although it identifies the study as “multicenter.” There is a quote from an individual identified as a “study investigator” but no other information is offered, including any disclosures as to possible conflicts of interest.
The release does refer to “other approved drugs in the category” but it provides no information about what other approaches might be useful in dealing with dry eyes. The National Eye Institute, for example, offers several approaches to dealing with the problem including prescription and over-the-counter medications, as well as surgical procedures.
This was another close call. We’ll rate this category satisfactory since the release reports on a phase 3 trial, which means the product is not yet available to the public, and a Sun Pharma executive is quoted as saying, “We look forward to discussing these results with US FDA and agree on next steps for the program.” FDA approval is prerequisite on a product’s availability to the public.
There are several other forms of cyclosporine A solutions already available to the public for treatment of this condition (such as the prescription medication Restasis) and this release is arguably linked to an attempt to enter that market. With little data provided in the release, it’s hard to discern what makes this drug novel.
The release does not appear to use any unjustifiable language.