Eyeworld

EW FEATURE 116 New technology in cataract surgery • April 2016 by Maxine Lipner EyeWorld Senior Contributing Writer AT A GLANCE • Omidria helps to maintain a larger pupil during surgery and forestall pain. • With the dropless approach physicians are minimizing the need for postop medications by injecting agents at the end of surgery. • A dexamethasone-emitting punctal plug may also stave off the need for steroid drops after cataract surgery. Omidria formulation doesn't address an unmet need in his practice. Intravitreal experience Jeffrey Liegner, MD, Eye Care Northwest, Sparta, New Jersey, who was one of the creators of the Tri- Moxi and Tri-Moxi-Vanc intravitreal approach, explained that the need for this sprang from a confluence of events around 2010. At that time, Medicare had given instructions that all medications be single-use only. "We had to find something in a unit dose, and in the case of vancomycin, the smallest one came in a 500-mg vial. We would use 25 mg and throw out the rest of it—that didn't make any sense." The other contributing factor was soaring prices for the topical eye drops. "They were ridiculously expensive, and the prices were going up rapidly, particularly the antibiot- ics," Dr. Liegner said. Also, insurance formularies became much more restrictive. "Sometimes without telling us they were forcing us into generics, less functional or lower performing drugs, and that was unacceptable," he said. Although it is off label, David F. Chang, MD, clinical professor of ophthalmology, University of California, San Francisco, and in private practice, Los Altos, Califor- nia, continues to routinely place epinephrine in the irrigation bottle to maintain pupil dilation, which he has found to be highly effective. "In 2014 we published our findings 2 that if there is no epinephrine in the bot- tle, there is a 4–5% rate of severe IFIS and a 12–14% rate of moderate to severe IFIS in patients who've never take alpha blockers," he said. "I do think it is important to add an alpha agonist to the irrigation bottle." Dr. Chang pointed out that there is a huge cost discrepancy. "Epinephrine costs about $4 per vial, and lacking any evidence that Omidria is superior to epinephrine at maintaining mydriasis, I person- ally can't justify using a product that is more than 100 times more expensive," he said. Although he is glad the Centers for Medicare & Medicaid Services (CMS) has a pro- gram to subsidize patient access to newly developed drugs, in this case with a $4 alternative that he has suc- cessfully used for decades, the new "It helps maintain pupillary dilation during surgery and reduces discom- fort during surgery and in the imme- diate postoperative period." Number 2, he said, there is pass-through reimbursement. "This means that it costs my patients nothing and it costs me nothing," Dr. Lindstrom said. As Thomas Gustafson, PhD, explained in the September 2015 issue of ASC Focus, 1 with transitional pass-through, in addition to paying for the facility fee, for a limited time (usually 3 years), Medicare offers additional reimbursement for inno- vative drugs, devices, and biologics. The idea is to allow access to these unique products, such as Omidria, initially without having to fit anoth- er expenditure into the usual facility fee payment. In Dr. Lindstrom's view, another factor in the case for using Omidria is that it's a chance to invest in innovation for practi- tioners like himself who advocate for new technologies. Part of Omidria's appeal is that it helps maintain a larger pupil during surgery, Dr. Lindstrom explained. "It's intended to retain pupillary dilation during surgery and reduce pain and discomfort during surgery and in the immediate postoperative period," he said. "But we know that there is data in the literature to support a lower com- plication rate in patients who have larger pupils." Also, if the patient is more comfortable, it makes for easier surgery. Because of what Omidria has to offer, a significant number of prac- titioners use this for their high-risk patients, Dr. Lindstrom noted. Such patients would include those with intraoperative floppy iris syndrome (IFIS) because these individuals are hard to dilate and have pupils that tend to come down during surgery. Still, in many cases it can be hard to tell ahead of time who will benefit. "The reality is that it's sometimes hard to predict which patient is going to be difficult," he said. However, not everyone is con- vinced that Omidria is the answer. Physicians discuss innovative medications for inside the eye during phacoemulsification W hen it comes to cataract surgery, one new approach gaining momentum is to add the medicine to the irrigating solution during the procedure or inside the eye after the lens has been replaced. The new drug Omidria (Omeros, Seattle) as well as dropless cataract surgery are making inroads. With the drop- less approach, practitioners inject combination agents such as Tri-Moxi (triamcinolone and moxifloxacin, Imprimis, San Diego) and Tri-Moxi- Vanc (triamcinolone, moxifloxacin, and vancomycin, Imprimis) at the end of the procedure to forestall or minimize the need for postop- erative medications. In addition, there is movement toward using a sustained-release dexamethasone punctal plug (Ocular Therapeutix, Bedford, Massachusetts) to treat inflammation related to cataract surgery. EyeWorld took a closer look at these. Focus on Omidria Richard Lindstrom, MD, adjunct professor emeritus, University of Minnesota, Minneapolis, routinely uses Omidria for his cataract pa- tients. His rationale here is multifac- eted. "Number 1, it works," he said. Inside look: New drugs for cataract surgery The dexamethasone punctal plug has a fluorescent component that makes it possible to see in the eye. Source: Shamik Bafna, MD

• Cover