JAN 2014

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

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January 2014 demonstrating the importance of the combination of both phenylephrine and ketorolac. In addition, those treated with Omidria had significantly less intraoperative pupil constriction during cataract surgery than did controls or ketorolactreated patients. Likewise, in the phase 3 studies, significantly fewer had pupil size of less than or equal to 6 mm when Omidria was used. Omidria is compatible with any type of balanced salt solution, Dr. Whitaker said. Omidria is packaged in a single-dose vial that could be drawn up by a nurse or a pharmacist and injected into the balanced salt solution just before they hang it on the machine. If it receives FDA approval, Dr. Whitaker thinks it could be used in all phacoemulsification cases. "The clinical trials had broad inclusion criteria and we saw these effects across the population," he said. In addition, ophthalmologists have indicated that for certain patients this could be particularly well suited. "Surgeons talk about IFIS patients a lot, so we're initiating a trial for floppy iris," Dr. Whitaker said. "If that clinical trial is positive, that would help the patients." 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 reg- ulatory agencies are reviewing both applications," Dr. Whitaker said. EW Editors' note: Dr. Lindstrom has financial interests with Alcon (Fort Worth, Texas), Allergan (Irvine, Calif.), Bausch + Lomb (Rochester, N.Y.), and Omeros. Dr. Whitaker has financial interests with Omeros. EW NEWS & OPINION Contact information Lindstrom: 952-567-6051, rllindstrom@mneye.com Whitaker: swhitaker@omeros.com 17

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