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Omeros Corporation ( OMER - Snapshot Report ) recently announced that it successfully completed the 90-day safety database lock for the second of its two phase III studies on OMS302. OMS302 is being developed for use in patients undergoing intraocular lens replacement surgery.
The candidate was well tolerated, though both OMS302 and placebo had a similar incidence of adverse events.
OMS302 is intended to maintain intraoperative mydriasis (pupil dilation) and lessen postoperative pain and irritation due to cataract and other lens replacement surgery.
In Nov 2012, Omeros had reported positive data from the study on OMS302. Results from the study showed that OMS302 achieved statistically significant maintenance of intraoperative mydriasis as well as reduction of pain in the early postoperative period.
Omeros plans to submit a New Drug Application (NDA) for the candidate in the US soon. The company also has plans to submit a Marketing Authorization Application for OMS302 to the European Medicines Agency in mid-2013. the company expects to launch the product in the first half of 2014.
Meanwhile, we remind investors that Omeros reported mixed results last month on its other pipeline candidate, OMS103HP, from its first pivotal phase III study that was being conducted in patients undergoing arthroscopic partial meniscectomy surgery.
OMS103HP failed to meet its primary endpoint (Symptoms Subscale of the Knee Injury and Osteoarthritis Outcome Score [KOOS]) in the study. However, Omeros said that OMS103HP achieved statistical significance in the secondary endpoint - pain measured in the early postoperative period.
An improvement was observed in other pain-related assessments like postoperative narcotic usage, the occurrence of inflammatory adverse events, use of tourniquets and crutches and time to discontinuation of crutches and return to work.
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