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Omeros (OMER) Starts Planned Pharmacokinetic Substudy In OMS302 Phase 3 Program

 May 31, 2012 09:37 AM

(By Balaseshan) Omeros Corp. (NASDAQ:OMER), a clinical-stage biopharmaceutical company, said it has started the planned pharmacokinetic substudy in its Phase 3 clinical program evaluating OMS302 in patients undergoing intraocular lens replacement (ILR) surgery.

The company is conducting the pharmacokinetic (PK) substudy to confirm the low levels of systemic exposure previously observed in preclinical studies of the drug product. OMS302 is being developed for use during intraocular lens replacement (ILR) surgery, including cataract surgery and refractive lens exchange.

Blood samples will be collected prior to and during the first 24 hours after surgery from each of twelve OMS302- and placebo-treated patients in the ongoing second OMS302 Phase 3 clinical trial. These data will be included in Omeros' OMS302 marketing applications in the United States and the European Union.

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In the first Phase 3 clinical trial of OMS302, the drug product demonstrated statistically significant superiority over placebo in maintenance of intraoperative mydriasis and reduction of postoperative pain.

Omeros is now conducting the second Phase 3 clinical trial, which is expected to enroll about 400 patients. This trial will evaluate the same efficacy and safety measures as the earlier successful Phase 2b and Phase 3 clinical trials.

The company remains on track to announce data from its second Phase 3 OMS302 clinical trial in the second half of 2012 and, assuming positive results, to file both an NDA and MAA in the first part of 2013.

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OMS302, one of Omeros' proprietary PharmacoSurgery products, is added to standard irrigation solution used during ILR procedures to maintain intraoperative mydriasis (pupil dilation) and reduce postoperative pain.

The company's recent discussions with U.S. and E.U. regulators confirmed its expectations that this 24-patient substudy should provide sufficient PK data for its OMS302 marketing applications.

OMER closed Wednesday's regular session up 0.10% at $10. The stock has been trading between $3.16 and $10.88 for the past 52 weeks.

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