Xiidra takes the stage: Keenly anticipated medicine available to treat dry eye disease

An expert gives the rundown on this new treatment as practices start to integrate it into their protocols.

Issue: September 25, 2016

ByDarrell E. White, MD

Well, Labor Day has come and gone, so I guess it is time for my annual September lifitegrast — now Xiidra — column. After what seemed like forever, the FDA approved Xiidra in July for the treatment of both the signs and symptoms of DED. I have had the opportunity to use it for about 6 weeks. Why don’t we take a little bit of time and review what it is, how it works and how you can integrate it into your DED protocols in the near term.

In the DED community of physicians, it is now axiomatic that DED is a progressive inflammatory disease. Depending on what is primarily affected, the inflammation causes a decrease in either tear quantity or tear quality, or both. The societal impact of DED is great, and it is growing. Conservative estimates are that there are 25 million sufferers, but if you accept that DED is the second most common cause of blurred vision (after ametropia), the number is likely closer to 50 million or 60 million in the United States alone. Computer and cell phone use, along with decades of industrial food production, can only be expected to increase these numbers.

All about Xiidra

Xiidra is a first-in-class LFA inhibitor that acts to prevent both the activation of lymphocytes as well as the recruitment of those activated lymphocytes to the ocular surface. While it reduced the signs of DED in the studies designed to primarily examine that, the most notable thing I took from the cumulative research submitted to the FDA was that the symptoms of DED were decreased in pretty much all of the studies. Remember, I am the DED symptom guy; I have been pounding the importance of driving your DED treatment protocol according to your patient’s symptoms for years. It is an equally big deal that the FDA considered symptoms at all, frankly.

Prescribing Xiidra and educating your patients is going to feel familiar to you if you have been treating DED already. Expect it to be priced comparably to Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan) and Lotemax Gel (loteprednol etabonate ophthalmic gel 0.5%, Bausch + Lomb). This should not be a surprise, and noting it is in no way a criticism. Xiidra is a twice-a-day medicine that comes in sterile, preservative-free dropperettes. A 1-month supply will be 60 “bullets,” one to be used in both eyes in the morning and one for the evening. I know what you are thinking. To mitigate the financial impact, we are going to be able to game the system a bit on behalf of our patients and have them use one bullet for both daily doses. Not yet, at least for us. For the moment we will be instructing our patients to play it straight as we gather data from our initial experience.

At SkyVision we will be utilizing the studies submitted to the FDA in our patient counseling. Xiidra was well-tolerated by the overwhelming majority of study participants, so we will instruct our patients that they should expect only mild irritation when they are using it, if they experience anything at all. Of course, we will make sure to spell check “dysgeusia” on our education collateral because a “change in sensation of taste” was noted in approximately 15% of patients. Symptomatic relief seems to begin around 2 weeks into treatment, so we will not be prescribing a steroid or other medication during the initiation period. (Note: Every DED patient is “prescribed” a specific artificial tear as part of their treatment regimen.)

Potential patients

Who should you consider for treatment with Xiidra? This is a brand new medicine, and it is up to you to decide whether or not you will use it right away on newly diagnosed patients. Let me state once again that you should not be taking your successful, asymptomatic Restasis patients and switching them over to Xiidra. Seriously, that makes no sense at all. If you have been treating DED for any length of time, you undoubtedly have a list of patients who did not do well on Restasis for any of a number of reasons and are essentially untreated at the moment. If you continue to be convinced that they do, indeed, have inflammatory DED, go ahead and put those patients on Xiidra.

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In all likelihood, there are lots of “low-hanging fruit” in your practice when it comes to choosing patients for your first Xiidra experiences. In a perfect world, we would have very few patients on chronic topical steroids for any reason, but especially for chronic symptomatic DED. We have been keeping a list of these patients for some time now, and I will be systematically attempting to change them to Xiidra. Our practice has a rather high number of very severe DED patients who have gotten a tremendous amount of relief from Restasis but still have either residual symptoms or signs that need to be addressed. While this may not be a classic indication, I admit that I have been looking forward to adding Xiidra to the regimen for these patients.

Those of us who implant advanced IOLs in cataract surgery, especially presbyopia-correcting IOLs, have long known the benefit of maximizing the health of the ocular surface. But for the expense, you could make the case for all cataract patients to accelerate their visual recovery. In the advanced IOL space (and for that matter the LASIK/PRK space), it is more than reasonable to evaluate a patient preoperatively and treat everyone who has symptoms or signs of DED. Here we can take advantage of Xiidra’s 2-week onset of effect. A side benefit is that this should create little to no effect on surgical scheduling.

Insurance process

Which leaves only (hides face) insurance coverage for Xiidra. Akorn is going back to the specialty pharmacy/mail-order strategy to make their specialty medications affordable. As I have said before, there is nothing inherently wrong with serving up a little bit of their own “medicine” to insurance companies by putting a specialty pharmacy in charge. Shire is going this one better with the engagement of an intermediary company best described as a concierge for the patient. “Ask IIRIS” is due to kick in sometime in September; at the time of writing, we do not yet have any experience with the company. It goes without saying that I am a fan of anything that gets doctors and staff out of the insurance process.

These are exciting days for those of us who treat DED. The approval of Xiidra for treating both the signs and symptoms of DED is most welcomed, indeed. Keep your eyes on my OSN Dry Eye blog for updates on our SkyVision experiences with Xiidra. A tip of the hat to Allergan, as always, for creating this space. Hats off to Shire and the folks in its eye care unit for marshalling this important new medicine on its journey from the lab to the lives of our patients.

Fasten your seatbelts. This should be quite a ride.

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.