Eyeworld

69 EW CORNEA September 2016 North Carolina), and TopiVert (Lon- don). Dr. Trattler has financial interests with Allergan and Shire. forward to seeing what kind of addi- tional benefit Xiidra can offer," Dr. Trattler said. He said he may begin patients on Xiidra initially to see the response before adding in adjunctive treatments. Quicker onset of symptom relief Dr. Hovanesian cautions his cur- rent dry eye patients that treatment won't "cure" the disease, nor will relief be immediate. Restasis reaches its full potential about 3 months after therapy begins; in the Xiidra studies, relief was noticed as early as 14 days. "Restasis takes awhile before it makes a meaningful impact on patients' tear supply," Dr. Hovanesian said. "Some patients experience sting- ing and redness. While there is some local surface irritation that caused a few Xiidra patients to discontinue the drug, it's not common. One of the most common symptoms people experienced with Xiidra that did not seem to be an issue with Restasis was dysgeusia, or altered taste. For most patients, it wasn't terribly unpleasant in the study. We had patients in our office who were part of the clinical trials, and it was noticeable to some of them. That is something that we should prepare patients for when we prescribe Xiidra." Down the road Dr. Hovanesian hopes the Xiidra approval will open the door for other companies and that barriers to approval will become easier to overcome. "Dry eye is such an important and common disease," he said. "Shire had a new mechanism of action with lifitegrast, and over the past decade or so, the pendulum has swung toward more rigor than is probably appropriate. Since the approval of Restasis 13 years ago, we've had several failed drugs that attempted to get an indication for dry eye." Those include diquafosol, which showed significant promise but did not pass the rigorous FDA re- quirements, although it is approved elsewhere. The "FDA is doing its job of try- ing to protect the public from unsafe or ineffective treatments, but we hope that the requirements will ease up a bit," Dr. Hovanesian said. There are currently more than 100 clinical studies underway eval- uating dry eye treatments. Drugs in the pipeline also address the inflam- matory cascade aspect of the disease. Shire's study involved more than 2,500 patients, and other companies are enrolling equally high numbers of subjects. Dr. Sheppard named several other potential dry eye treatments, including a sodium channel blocker, an aldehyde blocker, a neurotrophin mimetic, narrow spectrum kinase inhibitors, testosterone analogues, topical forms of loteprednol, new cyclosporine concoctions, direct nasal neurostimulation, drug-eluting punctal plugs, and a recombinant human serum albumin protein that are all being evaluated in topical form. "There continues to be inter- est in this space, and I'm sure we'll eventually find there are a few peo- ple who don't respond adequately to Xiidra," Dr. Sheppard said. "These other treatments may end up being those patients' salvation." Dr. Trattler said there may be synergies between Xiidra and Restasis, but data is needed and real-world outcomes need to be reported before he advocates using the two as a combination with other tried and tested therapies. "Each new offering changes the game for our dry eye patients," Dr. Hovanesian said. "If there's one thing we know about dry eye, it's that no one treatment works for every patient. We have to custom- ize and to some extent experiment with individuals to find their best treatment." EW Editors' note: Dr. Hovanesian has financial interests with Allergan and Shire. Dr. Sheppard has financial in- terests with Alcon (Fort Worth, Texas), Aldeyra Therapeutics (Lexington, Mas- sachusetts), Allergan, Bausch + Lomb (Bridgewater, New Jersey), LacriScience, Novaliq (Heidelberg, Germany), Ocular Therapeutix (Bedford, Massachusetts), Paragon (Baltimore), Parion (Durham, North Carolina), Rapid Pathogen Screening (Sarasota, Florida), Science- Based Health (Houston), Shire, TearLab (San Diego), TearScience (Morrisville, Contact information Hovanesian: jhovanesian@harvardeye.com Sheppard: jsheppard@vec2020.com Trattler: wtrattler@gmail.com

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