EyeWorld Asia-Pacific September 2015 Issue

52 EWAP PHARMACEUTICALS September 2015 Eye-opening mydriatic agents by Maxine Lipner EyeWorld Senior Contributing Writer A large pupil such as this one can make cataract surgery less complex for the physician. Source: Eric Donnenfeld, MD The latest on these dilating drugs T hey’re an extremely helpful part of cataract surgery and are used in nearly all cases—mydriatic agents. “Mydriatic agents are the unsung hero in cataract surgery,” said Eric D. Donnenfeld, MD , clinical professor of ophthalmology, New York University Medical Center, New York. “Good pupillary dilation is what separates good surgeons from great surgeons, and having a good dilation makes the surgery more efficacious, safer, and less stressful.” What’s more, initial dilation isn’t enough, he continued. Pupils will constrict during cataract surgery and physicians have to maintain dilation during the procedure; otherwise it becomes more difficult throughout the case, he explained. For cataract surgery, practitioners routinely turn to short-acting dilating agents such as Mydriacyl (tropicamide, Alcon, Fort Worth, Texas) or Cyclogyl (cyclopentolate, Alcon), as well as sympathomimetics like epinephrine or phenylephrine, he said. These can all be used preoperatively. In the operating room, epinephrine or phenylephrine and now Omidria (phenylephrine and ketorolac injection, Omeros, Seattle) can be used intracamerally to keep pupils dilated during surgery, Dr. Donnenfeld said. Of these only preservative- and bisulfite- free Omidria and one brand of epinephrine, which contains bisulfites, are U.S. Food and Drug Administration (FDA)-approved for this use. An important tool Edward J. Holland, MD , professor of ophthalmology, University of Cincinnati, likewise stressed the importance of mydriatic agents. “When we have a widely dilated pupil we take that for granted—the operation is inherently less complicated,” he said, adding that when the pupil comes down to 4, 5, or 6 mm, everything gets harder. “Whatever we can do to maintain a large pupil [allows us to be] better surgeons, and our patients have better outcomes,” Dr. Holland said. “Even the seemingly straightforward cataract, a 1 to 2+ nuclear sclerotic cataract, an 8-mm pupil, and a cooperative patient becomes a challenge when the pupil constricts to 4 mm. That case now becomes a difficult one,” Dr. Holland said. “Every case benefits from a widely dilated pupil.” To keep the pupil from constricting, different dilating drops are given to the patient preoperatively, and in the OR other agents may be added. “Most surgeons add epinephrine to the bag or the bottle—that’s what we’ve been using,” Dr. Holland said. “Epinephrine helps maintain pupillary dilation.” While this has been a go-to agent for many, it hasn’t been without problems, Dr. Holland said, adding that there have been shortages of the drug, and the epinephrine isn’t always bisulfite- free, which can lead to complications. “Secondly, if we need additional dilation during the case, we have to add a compounded agent in the OR—typically a mixture of epinephrine and/or lidocaine,” Dr. Holland said. While these are helpful and effective, federal regulations are increasingly restricting their use. “Some hospital-based surgical centers are not allowing compounded substances to be used,” he said. “In the past we have depended on compounded epinephrine and lidocaine, but that may not be available in the future.” Newest mydriatic agent Dr. Holland thinks the newest agent on the market solves a lot of these issues—the FDA-approved Omidria. This is a combination of the NSAID ketorolac and phenylephrine, Dr. Holland explained. “This product is FDA-approved for maintaining pupil size by preventing miosis and for reducing postoperative pain in surgery,” he said. It is not compounded and is already FDA-approved to add to the bag or bottle, he said. It is preservative- and bisulfite-free and has been found to be more effective than agents practitioners are currently using. “In the clinical trials, Omidria was compared to phenylephrine alone and ketorolac alone. The Omidria combination product was significantly better than either agent alone,” he said. “It is important to note that phenylephrine is known to be better than epinephrine so we can assume that Omidria will be superior to intracameral epinephrine. “I’ve been able to use Omidria since it has been FDA-approved, and I think that it’s the best agent added intracamerally to prevent miosis and reduce postoperative pain,” Dr. Holland said. Dr. Donnenfeld pointed out that if the pupils are dilated before