Omeros commences planned PK substudy in Phase 3 clinical program of OMS302

Jun 1 2012

Omeros Corporation (NASDAQ: OMER) today announced the initiation of the planned pharmacokinetic (PK) substudy in its Phase 3 clinical program evaluating OMS302 in patients undergoing intraocular lens replacement (ILR) surgery. Omeros is conducting the PK substudy to confirm the low levels of systemic exposure previously observed in preclinical studies of the drug product. 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.

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. In the first Phase 3 clinical trial of OMS302, the drug product demonstrated statistically significant superiority over placebo in maintenance of intraoperative mydriasis (p<0.00001) and reduction of postoperative pain (p<0.00001). Omeros is now conducting the second Phase 3 clinical trial, which is expected to enroll approximately 400 patients. This trial will evaluate the same efficacy and safety measures as the earlier successful Phase 2b and Phase 3 clinical trials. 

"Our recent discussions with U.S. and E.U. regulators confirmed our expectations that this 24-patient substudy should provide sufficient PK data for our OMS302 marketing applications," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros.  "Planned enrollment for this study was based in part on our preclinical studies, which demonstrated nominal levels of systemic uptake of OMS302.  We remain on track to announce data from our 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."