(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)
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
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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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.
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.