EyeWorld India March 2014 Issue
51 EWAP PHARMACEUTICALS March 2014 who received phenylephrine, he reported, 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 ketorolac-treated 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. CALENDAR OF MEETINGS 2014 DATE MEETing VEnUE April 2-6 XXXIV International Congress of Ophthalmology (WOC) 29th Asia-Pacific Academy of Ophthalmology (APAO) 118th Annual Meeting of the Japanese Ophthalmological Society (JOS) www.woc2014.org Tokyo Japan April 11-13 65th Annual Conference of Delhi Ophthalmological Society (DOS) www.dosonline.org/ Delhi India April 25-29 ASCRS-ASOA Symposium & Congress www.ascrs.org Boston USA July 5-6 2014 Indian Intraocular Implant & Refractive Surgery meeting www.iirsi.com Chennai India July 11-13 29th Annual Meeting of Japanese Society of Cataract & Refractive Surgery (JSCRS) www.jscrs.org Fukuoka Japan September 13-17 XXXII Congress of the European Society of Cataract & Refractive Surgery (ESCRS) www.escrs.org London UK September 17-21 19th Congress of Chinese Ophthalmological Society (COS) www.cmao.org.cn/eindex.asp China Xi’an October 18-21 Annual Meeting of American Academy of Ophthalmology (AAO) www.aao.org Chicago USA November 13-16 27th Asia-Pacific Association of Cataract & Refractive Surgeons (APACRS) Annual Meeting www.apacrs.org Jaipur India December 11-12 4th Biennial Scientific Meeting of the Asia Cornea Society www.acs2014.tw Taipei Taiwan 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 regulatory agencies are reviewing both applications,” Dr. Whitaker said. EWAP Editors’ note: Dr. Lindstrom has financial interests with Alcon (Fort Worth, Texas, U.S.), Allergan (Irvine, Calif., U.S.), Bausch + Lomb (Rochester, NY, U.S.), and Omeros. Dr. Whitaker is vice president of clinical development and chief medical officer of Omeros. Contact information Lindstrom: 952-567-6051, rllindstrom@mneye.com Whitaker: swhitaker@omeros.com
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