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EW CORNEA 36 November 2014 by Ellen Stodola EyeWorld Staff Writer trial data so far suggests that they would be useful. The one he thinks is closest to approval is lifitegrast (Shire, Lexington, Mass.), which has an anti-inflammatory effect. It is good for improving irritation symptoms. The company was planning to submit a new drug application to the FDA, he said, but there may need to be another trial. There is another drug showing efficacy in early clinical trials from Mimetogen (Gloucester, Mass.), he said. These two are likely the closest to approval, but Dr. Pflugfelder stated that the road to approval of dry eye therapies can be difficult. Dr. Luchs said Restasis (cyclosporine, Allergan, Irvine, Calif.), the only currently approved product for dry eye, works extremely well. "I think there are some prom- ising products that are currently being developed in the pipeline," he said. He mentioned lifitegrast and a product from Eleven Biotherapeutics (Cambridge, Mass.), both in ongoing trials. Difficulty earning approval There are a number of challenges when it comes to dry eye getting approval, Dr. Luchs said. One major reason is the need to show improve- ment in a clinical sign and a clinical symptom of dry eye disease. These are extremely variable targets that often improve significantly with the placebo. The differences between the therapeutic group and placebo group can be hard to showcase in the results. "Plus there's been a moving target with the [Food and Drug Administration] in terms of what it will accept with respect to primary endpoints for approvability of drugs for dry eye disease," Dr. Luchs said. Development of a better understanding of the pathophysi- ology of dry eye disease is leading to better medications to treat the underlying problem. Despite a large number of people suffering from dry eye, both diagnosed and undiagnosed, Restasis remains the only dry eye medication approved by the FDA. One reason for this, Dr. Pflugfelder said, could be the nature of the condition. "It's a heterogeneous disease, and there are people who have a low amount of tears, an aqueous (TearScience, Morrisville, N.C.), and tests for serum biomarkers of Sjögren's syndrome, such as the Sjö test (Nicox, Sophia Antipolis, France). Dr. Pflugfelder said he currently does not use any of these, but he plans to utilize the MMP-9 test in his office soon, as this identi- fies patients with inflammation. Dr. Pflugfelder has tested for Sjögren's biomarkers and finds them valuable, but he does not believe that they guide his therapy decisions, although they provide information that is useful for patients to know. Dr. Luchs is using a number of the currently available tests for dry eye disease and said they are working well for his patients. "I've engaged full force into adopting these new point-of-care diagnostics for dry eye," he said. "I think they enhance my ability as a physician to make diagnoses." These tests can provide objective measurements to follow for diagnosis and therapy. Dr. Luchs uses both the TearLab Osmolarity Test and the MMP-9 test, which he said are helpful to confirm a dry eye diagnosis. He also uses the patient history taken by his technicians and considers any allergies the patient has. The LipiView/LipiFlow System is another technology that Dr. Luchs has recently integrated into his practice. This is an important tool to help assess the contribution of the oil layer, he said. For those worried about the price of these new tests, Dr. Luchs said some reimbursement is provided to the physician. Dr. Luchs also uses the Sjö test because many patients with dry eye have undiagnosed autoimmune disease, specifically Sjögren's syndrome, he said. "This test is helpful to diagnose previously unseen Sjögren's syndrome." Dr. Luchs recommends some lid scrubs to patients, but the LipiFlow System tends to help specifically with this by relieving obstruction, and it works particularly well for patients with evaporative dry eye. Promising medications Dr. Pflugfelder thinks there are drugs in the pipeline that could be good for dry eye in the future. Clinical Dr. Pflugfelder said he uses a combination of tests for dry eye. "It starts off with having patients fill out a symptom questionnaire to identify what types of symptoms they're having, whether they're related to irritation, blurred vision, or environmental exacerbation," he said. Following that is a standard panel of tests, which includes an anterior segment OCT, topogra- phy, measuring tear break-up time (TBUT), staining of the cornea and conjunctiva, and a Schirmer's test. Other tests available for dry eye include the TearLab Osmolarity Test (TearLab, San Diego), the MMP-9 test (InflammaDry, Rapid Pathogen Screening, Sarasota, Fla.), the LipiView/LipiFlow System There is more on the horizon for dry eye diagnostics and therapeutics D ry eye therapies and medications are moving forward, with a number of new medications in the pipeline seeking approval and several new in-office tests for diagnosis. Stephen Pflugfelder, MD, Baylor College of Medicine, Houston; and Jodi Luchs, MD, South Shore Eye Care, Wantagh, N.Y., discussed tests they currently use and what looks promising for future treatment of dry eye. Dry eye technology, medications, and what's in the pipeline Artificial tears A rtificial tears are an important part of the dry eye treatment reg- imen. Jodi Luchs, MD, South Shore Eye Care, Wantagh, N.Y., prescribes artificial tears for a number of his patients, and especially favors preservative-free tears. "I think it's important to consider preservative-free therapy because patients self medicate with artificial tears, so it's hard to regulate how much they use," he said. When patients are more symptom- atic, they will use more tears, and when they are less symptomatic, they will use less, despite instructions from the physician. However, with preservative-free artificial tears, Dr. Luchs said he does not have to worry that patients will irritate their ocular surface with ex- cessive preservatives. The preservative-free tears are a little more expensive but worth it for safety and efficacy, he said. Dr. Luchs recommends the use of artificial tears for his patients in the earliest stages of dry eye disease all the way up to those with more signif- icant disease. "I think they're an important contribution and important component of the therapeutic regimen." There are many brands of artificial tears, including from Alcon (Fort Worth, Texas), Bausch + Lomb (Bridgewater, N.J.), and Pfizer (New York). Dr. Luchs often uses the Refresh brand (Allergan, Irvine, Calif.), but he uses others as well and said many are excellent and provide patients with exceptional comfort and relief. Artificial tears should fit with upcoming medications in the pipeline for dry eye disease. "What you have to remember is that all of the treatments that are currently being used or developed for dry eyes are not cures for the problem," Dr. Luchs said. "They can help to control the underlying pathophysiology to heal the ocular surface, improve the current state, and potentially slow the progression of the disease, but they're not cures." Dr. Luchs added that patients may need medication for their dry eye disease, but they might also need lubrication to help optimize the ocular surface and maximize comfort. He does not believe that the medications being developed will necessarily eliminate the need for artificial tears, but the two products should work together quite well. Editors' note: Dr. Luchs has financial interests with Allergan. Contact information Luchs: jluchs@aol.com