Eyeworld

EW FEATURE 48 Steroids roundup • August 2017 AT A GLANCE • Cyclosporine and lifitegrast are used off-label for T-cell mediated inflammatory reactions on the ocular surface, in conjunction with topical corticosteroids. • Topical cyclosporine replaces topical corticosteroids in patients with post-keratoplasty glaucoma. • When treating neovascularization, anti-VEGFs resolve the symptoms, but don't address the actual problem. • Physicians choose steroids based on the potency of their side effects. by Stefanie Petrou Binder, MD, EyeWorld Contributing Writer and his colleagues reported on the resolution of the symptoms of chronic dry eye following a mini- mum 6- to 72-month b.i.d. course of topical 0.05% cyclosporine. All eight patients experienced a complete resolution of dry eye. The study con- cluded that topical cyclosporine was a cure for the signs and symptoms of chronic dry eye, presumably as- sociated with the elimination of the underlying inflammatory process. 3 Cyclosporine works locally in the eye as a partial immune system modulator, increasing the eye's natural ability to produce tears. Tear production is thought to decrease when lymphocytes die and accumu- late in the lacrimal glands. Restasis (cyclosporine 0.05% ophthalmic emulsion, Allergan, Dublin, Ireland) effectively stops this process. "We have been using mainly Restasis to treat dry eye disease with relatively good success in the range of 80%. More recently, lifitegrast solution has come on the market, which has also been shown to be efficacious," Dr. Perry said. The main difference between Restasis and lifitegrast is their onset of action. Lifitegrast is effective with- in 2 weeks versus Restasis, which is effective in 3 to 6 months. Lifitegrast ocular hypertension. I performed a corneal transplant on a patient for keratoconus, and in order to maintain his graft, I kept him on corticosteroids. Unfortunately, his IOP kept increasing, in spite of max- imal medical therapy. This led us to choose topical cyclosporine as an alternative to corticosteroids, using a 0.5% solution diluted from the 5% IV solution. We used cyclosporine as a substitute for corticosteroids, and by eliminating the corticosteroids, the patient's IOP became normal and the cyclosporine was effective enough in terms of its anti-inflam- matory action to maintain the clar- ity of the graft and prevent precipi- tates from returning." The case Dr. Perry described was part of a study conducted in 25 patients with post-keratoplasty glau- coma. The study revealed that 84% of the patients (n=21) had a reduced IOP, and all maintained graft clarity in the follow-up period of 3 to 12 months. Following the trial period, three patients discontinued one or more glaucoma medications. 2 Dry eye Dr. Perry has successfully used cyc- losporine for a number of different indications. In a retrospective case series that he conducted in eight patients with chronic dry eye, he steroid for severe inflammation like uveitis or corneal transplant rejec- tion. If, however, you are treating a milder condition and you need a good steroid effect, but you're treat- ing long term and worry about side effects, you would choose a different steroid, such as loteprednol," Dr. Holland explained. Loteprednol is an ester steroid that is approved for treating in- flammation after surgery, allergic inflammation, uveitis, and some chronic forms of keratitis. It is the only approved ester steroid and is efficacious without the IOP-rais- ing effects of ketone steroids. "The benefit of difluprednate is that it is the most effective steroid, but the disadvantage is that it will cause a rise in IOP in approximately 10% of patients as the other ketone ste- roids," Dr. Holland said. "We tend to choose the safest steroid for chronic use, unless we really need to treat severe inflammation." Graft rejection Difluprednate has drastically changed ophthalmologists' ability to manage graft rejection. "In the past, the gold standard steroids were pred- nisolone or dexamethasone, the two most potent steroids," Dr. Holland said. "But we still had a significant number of patients who would break through, and we would either use intracameral preservative-free dexamethasone in chronic rejection patients or use oral immunosuppres- sive agents. But difluprednate used aggressively, either as a prophylaxis or as a treatment in acute endothe- lial rejection, has reduced our need to go to oral systemic immunosup- pression because it is such a potent corticosteroid. It has been a tremen- dous adjunct for the corneal surgeon in preventing or reducing inflamma- tion in patients." According to Henry Perry, MD, Long Island Surgicenter, Long Island, New York, the best drugs for treating acute graft rejection are corticosteroids, specifically prednis- olone acetate 1% solution. How- ever, drug choices in graft patients need to take IOP-raising effects into account. "In the mid 1990s I had several patients who had graft rejec- tions and developed steroid-induced Physicians say off-label drug use is a matter of good clinical practice in patients requiring long-term steroid therapy O ff-label drug use, i.e., used for indications other than those approved by the FDA, is often a necessary standard of care. The phy- sician's code of ethics is guided by patients' best interests, with off-la- bel options often representing the best feasible treatment alternative. EyeWorld spoke with three special- ists about off-label drug use and the best available choices and delivery methods in their patients undergo- ing long-term steroid therapy. Drug choice based on side effects Roughly 50% of medications used routinely in ophthalmic practice are off-label. 1 Edward Holland, MD, Cincinnati Eye Institute, Cincinnati, thinks that when using the drugs at their disposal, ophthalmologists need to make discerning treatment decisions based on the condition of the individual patient. "We have a variety of steroid options, and we make the decision of which one to use based on the potency of the side effects. For instance, if you're most interested in managing severe inflammation, difluprednate is the most effective and potent topical Off-label but not off-limits Dry eye disease Source: Edward Holland, MD continued on page 50

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