Credit: Shutterstock photoOmeros CorporationOMER announced that the presiding European regulatory authority has approved the company's lead human monoclonal antibody OMS721 for compassionate use in the treatment of thrombotic microangiopathies (TMAs) including atypical hemolytic uremic syndrome (aHUS).
Omeros is investigating OMS721 in a phase II dose-escalation study for the treatment of patients suffering from aHUS. Based on positive observations in the first cohort of the study, the investigator requested extended access to OMS721 for compassionate use in his two aHUS patients treated in this cohort.
Omeros said that following approval from the European regulatory authority, it has released shipment of OMS721 to continue treatment of the two aHUS patients as part of the compassionate use study.
Meanwhile, Omeros completed treatment of patients in the second cohort of the study, which administered a higher dose than the first cohort. The company said that based on safety results from a pre-planned review of data from the second cohort by internal and external physicians, the study may be advanced to a third cohort at a higher dose. Patient dosing in the third cohort is expected to begin before the end of this month. OMS721 enjoys orphan drug status for the prevention of complement-mediated TMAs.
We note that Omeros' primary focus lies on the commercial launch of its only approved product Omidria in the U.S. The product is approved by the FDA for use during cataract surgery or intraocular lens replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. While a controlled launch of Omidria was already started in Feb 2015, a broader U.S. launch of the product is expected shortly. Omidria is currently under review in Europe for this indication.
Omeros carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector are SurModics, Inc. SRDX , Cytokinetics, Incorporated CYTK and GW Pharmaceuticals plc GWPH . While SurModics holds a Zacks Rank #1 (Strong Buy), Cytokinetics and GW Pharma carry a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
