Eyeworld

EW CORNEA 62 May 2017 by Maxine Lipner EyeWorld Senior Contributing Writer gives them the additional boost and stabilizes their disease," she said, adding that Xiidra is a new class of agent that works by a different mechanism of action than Restasis. With more anti-inflammatories, it is possible to hit the inflammatory cycle at different levels, making for a possibly bigger effect in the long run, she explained. For example, she cites a patient who had graft-versus- host disease and was on Restasis and would sometimes take a steroid as a rescue drop for flare-ups. "We did his InflammaDry test and it was not heavily pink, but a light positive," she said. "I added Xiidra to his regimen and about 4 to 6 weeks later saw him back, and his InflammaD- ry had gone negative." With both drops in the mix, Dr. Farid hopes that this patient will need his rescue steroids far less frequently. For his part, Dr. Starr finds that in the age of Xiidra, the conversa- tion with patients as to which of these medications to choose has gotten a bit more time consuming. "I go through the pros and cons of the drop with each patient, a brief overview of the FDA trial data and labeling, side effect profiles, onset of action expectations, as well as insurance coverage and cost con- siderations," he said. "After this, admittedly more complex conver- sation, it is usually quite evident which medication will work best for each particular patient and that is typically how I choose which to prescribe." Dr. Starr also says the product labels and indications, like the mechanisms of action, are fundamentally different between Xiidra and Restasis and therefore the underlying etiology and sub- type of dry eye disease is taken into consideration when deciding which drop to prescribe. "The Restasis label states it is indicated to 'increase tear production in patients whose tear production is presumed to be sup- pressed due to ocular inflammation associated with keratoconjunctivitis sicca' whereas the Xiidra label states it is indicated 'for the treatment of the signs and symptoms of dry eye disease'," said Dr. Starr. Role of steroids In some patients, he may also add a steroid if they are significantly inflamed. "If they have a moder- because it really gives us an addi- tional tool to treat the inflammatory component of dry eye disease," she said. The trials themselves, which included over 2,000 patients, were encouraging, with the patients who were on the active lifitegrast show- ing a dramatic improvement in their symptoms compared to those who were on the vehicle, she stressed. "I reach for Xiidra as a first treat- ment because it is shown to work as early as 2 weeks, and it shows a great symptomatic improvement in the majority of patients that I put on it," Dr. Farid said. "For many of my patients who are doing well on Restasis, I maintain their treatment since it is working well. Having the option of using Restasis or Xiidra has allowed much more flexibility for me as no one drop works perfect- ly for every patient." In addition, for a small group of patients who have very severe dry eye due to rheumatoid arthri- tis, graft-versus-host disease, or Sjögren's syndrome who have been on Restasis but still need something additional, Dr. Farid also will add Xiidra to the mix. "I think there may actually be some potential synergistic effects because it really ocular surface inflammation of the tissues and glands that produce not only aqueous but also mucin and meibum," Dr. Starr said. Unless the inflammatory cycle is disrupted, it typically gets worse and worse with time, which can lead to end-stage damage of structures of the ocular surface including the ocular corneal nerves and the glands that produce all of the important components of the tear film. "We know that by breaking that cycle with anti-in- flammatory medication or immu- nomodulatory medication, we can effectively treat dry eye and get the ocular surface back to optimization and good health," Dr. Starr said. Weighing Restasis and Xiidra While for many years Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan, Dublin, Ireland) was the only treatment approved to address the inflammatory nature of dry eye, Xiidra (lifitegrast, Shire, Lexington, Massachusetts), with its U.S. Food and Drug Administration (FDA) approval in July 2016, has also become a viable option, Dr. Farid ob- served. "As a doctor who treats a lot of dry eye, it's very exciting for me that we got the approval for Xiidra Update on immunomodulation for dry eye disease W hile once dry eye patients were often placed on artificial tears to at least as- suage the condition, these days, practitioners have a new understanding of the inflamma- tory nature of the condition. This goes for different types of dry eye conditions, according to Marjan Farid, MD, associate professor of ophthalmology, Gavin Herbert Eye Institute, University of California, Irvine. "Whether patients start out with aqueous deficient or evapora- tive dry eye, the end result of both is inflammatory in nature," Dr. Farid said. EyeWorld took a closer look at the latest in immunomodulation for dry eye patients. Dr. Farid points out that excel- lent diagnostics have helped to con- firm that the condition is indeed an inflammatory one. Tests such as In- flammaDry (Rapid Pathogen Screen- ing, Sarasota, Florida) have found inflammatory cytokines are present in tear film samples of chronic dry eye sufferers, she noted. Also, for years when practitioners would put those with dry eye on steroids for other reasons, they would find that the patients' dry eyes would improve. "That was one of the early indicators that we were dealing with an inflammatory disease," she said. "Obviously, steroids are excellent, potent anti-inflammatories, but we're limited in their long-term use because of side effects." The importance of immunomodulation as not steroidal has become key to treating a large majority of dry eye patients with inflammatory tears, she stressed. Christopher E. Starr, MD, as- sociate professor of ophthalmology, Weill Cornell Medicine, New York, concurs that there's now a lot of evi- dence of the inflammatory nature of the disease. He cites the 2007 Report of the International Dry Eye Work- shop, which included terms such as abnormal osmolarity and inflam- mation. "We know that immuno- modulation and anti-inflammatory medications can certainly help dis- rupt the root cause of the dry eye— this sort of smoldering, underlying Getting beyond the dry front This patient with significant corneal staining would be an ideal candidate for a prescription medication such as lifitegrast or cyclosporine. Source: Christopher E. Starr, MD continued on page 64 Pharmaceutical focus

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