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Stock Market & Financial Investment News

News Breaks
June 2, 2014
07:04 EDTOMEROmeros receives FDA approval for Omidria
Omeros announced that the FDA has approved Omidria 1%/0.3% for use during cataract surgery or intraocular lens replacement to maintain pupil size by preventing intraoperative miosis and to reduce postoperative pain. The approval comes with no post-marketing commitments other than the previously agreed study of Omidria for use in pediatric patients, which, if successfully completed, makes the drug eligible for an additional six months of marketing exclusivity in the U.S. With FDA approval of Omidria, Omeros is completing preparations for a late summer/early fall 2014 U.S. product launch.
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May 22, 2015
07:10 EDTOMEROmeros receives positive opinion from EMA's committee for Omidria
Omeros announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for Omidria 1%/0.3%. Omidria is used during cataract surgery and other intraocular lens replacement procedures to maintain mydriasis, prevent miosis, and reduce postoperative eye pain. Cataract surgery and IOL replacement are among the most common surgical procedures worldwide, with approximately 3.9 million of them expected to be performed in Western Europe alone in 2015. Omidria was approved by the FDA in 2014 and last month was made broadly available nationwide for commercial use.
May 11, 2015
16:40 EDTOMEROmeros reports Q1 EPS (51c), consensus (63c)
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