Eyeworld

EW RETINA 76 September 2018 Pharmaceutical focus New non-bioerodible intravitreal implant by Maxine Lipner EyeWorld Senior Contributing Writer better the patient can get with a safer side effect profile than with steroids," he said. "However, if there is no response or a worsening, I will consider a relatively early change." That said, however, based on the DRCR.net Protocol T recommen- dations, 1 which compared three an- ti-VEGF agents for diabetic macular edema, he will choose the anti-VEGF to use, keeping patients' acuity in mind. "I will start with Avastin in the majority of my patients who have good vision and diabetic macu- lar edema," Dr. Luo said. "However, if they have less than 20/50 vision, I will start with intravitreal Eylea." If they do not improve, he moves quickly to a steroid. The one caveat is for those with better vision who he starts on Avastin. Even if the patient does not have much of a re- sponse, he will switch to a full three- course treatment of Eylea, which in some patients may have higher efficacy than Avastin. However, if this is not effective, he considers intravitreal steroid use. Steroid challenge requirement Practitioners cannot move directly to Iluvien use without trying anoth- er steroid first, Dr. Luo pointed out. "Because of the way the FDA worded the label, there's no requirement for Elucidating Iluvien use F or patients with diabetic macular edema, one new treatment method gaining notice is Iluvien (fluocino- lone acetonide intravitreal implant, Alimera Sciences, Alpharet- ta, Georgia). This non-bioerodible implant continuously elutes the steroid fluocinolone acetonide at a low dose for up to 3 years, according to Caesar Luo, MD, Bay Area Retina Associates, Walnut Creek, California. This implant is capped at one end and has a polyvinyl alcohol ma- trix that dissolves over time, releas- ing a slow and steady therapeutic dose of fluocinolone acetonide for treating diabetic macular edema, Dr. Luo explained. Integrating Iluvien The Iluvien implant is one of two FDA-approved steroid devices used in the eye as a second-line therapy, Dr. Luo noted. "The standard of care for most retinal physicians is to start with an antivascular endothelial growth factor [anti-VEGF] medica- tion," he said, adding that unless the macular edema is well outside the center of vision, primary therapy is usually the anti-VEGF approach. "Then most of us are treating once a month to determine the respon- siveness of the macular edema to anti-VEGF therapy," Dr. Luo said. "If we think the patient is a suboptimal responder or failing anti-VEGF ther- apy, we consider use of steroid inside the eye." Glenn Stoller, MD, Ophthalmic Consultants of Long Island, Rock- ville Centre, New York, pointed out that the issue with first-line diabetic retinopathy treatment compounds such as Eylea (aflibercept, Regen- eron, Tarrytown, New York), Lucen- tis (ranibizumab, Genentech, South San Francisco), or Avastin (bevaci- zumab, Genentech) is that they only block VEGF. "Exudative age-related macular degeneration is primarily a VEGF driven disease. However, the pathogenesis of diabetic macular edema can be much more compli- cated," Dr. Stoller said. "There are different factors that cause swelling of the retina; it's not only VEGF." Some of these other factors are ad- dressed by intravitreal steroids. The second-line approach in- volves use of intravitreal steroids in the form of either Ozurdex (Aller- gan, Dublin, Ireland), which elutes dexamethasone, or the Iluvien im- plant. Aside from the different ste- roids, there are similarities between the two, such as that both implants come preloaded in a dispenser with a sharp needle. "You insert the needle into the eye and press an ac- tuator that causes the implant to be delivered into the vitreous cavity," Dr. Stoller said. One key difference between the two is that one implant is bioerodible while the other is not. Initially, Dr. Stoller usually gives three to four injections of anti-VEGF to see how a diabetic macular edema patient is responding before considering moving on to an intravitreal steroid approach. Still, consideration of intravitreal steroid use may come down to patient selection and weighing risk factors. "There are a number of variables to consider, such as the patient's lens status, history of glaucoma, history of a steroid response, the degree of residual swelling, the amount of associated vision loss, and what the vision in the patient's fellow eye is," Dr. Stoller said. Dr. Luo also starts with anti- VEGF therapy. Determining how long to stick with this strategy can be a balancing act. Dr. Luo pointed out that in some instances even when it appears the medication isn't working, it is just a question of time. "There is a subset of patients who will improve with a longer course of monthly injections," Dr. Luo said. "They may not see a response for 6 months or even 1 year." The problem is that there is also a subset of patients who don't recover even with monthly injections of anti- VEGF therapy. "There's the risk that you have left some of these patients undertreated for an extended period of time," he said. He relies on patient signs to determine the best course. If the macular edema is getting worse, Dr. Luo will quickly consider using an intravitreal steroid. He also exam- ines the appearance of the fluid. "There are some patients who have diffuse and cystic fluid with a lot of outer retinal atrophy and loss," he said. "I will start considering steroid use at a very early stage for those patients, especially if after initiation of anti-VEGF therapy, they have not shown a response." In cases where there is even a mild response either in terms of visual acuity or central foveal thick- ness or macular volume, Dr. Luo will continue patients on anti-VEGF therapy. "I want to see how much Eye of a diabetic macular edema patient upon first receiving the Iluvien implant in October 2016, with baseline vision of 20/50

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