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by Maxine Lipner EyeWorld Senior Contributing Writer   IN EYEWORLD JAN 2014
      New agent may be added to balanced salt solution for use during cataract surgery Balanced salt solution is a vital part of the cataract procedure, helping to irrigate away the nucleus during phacoemulsification. A drug pending FDA approval called Omidria (OMS302, Omeros, Seattle) may bring a new dimension to this part of the procedure, according to Steve Whitaker, MD, vice president of clinical development and chief medical officer of Omeros. Omidria, which contains both phenylephrine, known to be a mydriatic, and the NSAID ketorolac, is added to the balanced salt solution at the start of cataract procedure, he explained. Unlike drops given preoperatively, this medication is irrigated through the eye throughout the surgery, which is important, he said. "If the iris is irritated during the procedure, it releases prostaglandins, and prostaglandins can cause miosis," Dr. Whitaker explained, adding, "The ketorolac inhibits the cyclooxygenase enzymes that produce prostaglandins, so ketorolac can block that irritation-induced miosis." Dr. Lindstrom views complex cases as particularly well suited for Omidria since pupils tend to constrict when surgery takes longer. "Or if you have a novice surgeon, where the case does take a longer time, you can expect more pupillary miosis," Dr. Lindstrom said. "The longer the case, the more uncomfortable patients tend to get as well." In addition, those with blue irises he finds are more prone to discomfort, as are high myopes. Side effects with Omidria appear comparable to, and without greater incidence than, those typically reported by patients undergoing cataract surgery, Dr. Whitaker said. "In the clinical trials, incidence of adverse events was similar between OMS302 and the control groups," he said. "The most commonly reported adverse events postoperatively that were observed were eye pain and inflammation, increase in intraocular pressure, and headache, and they are typical of the surgery." Currently, Omidria remains under review. "We filed the NDA in the U.S. last summer and the MAA in Europe in September, and the regulatory agencies are reviewing both applications," Dr. Whitaker said.





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