Omeros Corp Announces Initiation of Planned Pharmacokinetic Substudy in OMS302 Phase 3 Clinical Program

Omeros Corp 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' 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 superior over placebo in maintenance of intraoperative mydriasis (p<0.00001) and reduction of postoperative pain (p<0.00001). Omeros is 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.