Omeros Announces Initiation of Planned Pharmacokinetic Substudy in OMS302 Phase 3 Clinical Program
BY PR Newswire — 7:00 AM ET 05/31/2012
SEATTLE, May 31, 2012 /PRNewswire/ -- Omeros Corporation (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 (OMER) 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 (OMER)' OMS302 marketing applications in the United States and the European Union.
OMS302, one of Omeros (OMER )' 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 (OMER) 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 (OMER). "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."
About Omeros (OMER )' OMS302 Program
OMS302 is Omeros (OMER)' product being developed for use during intraocular lens replacement (ILR) surgery, including cataract surgery and refractive lens exchange. OMS302 is a proprietary combination of ketorolac, an anti-inflammatory agent, and phenylephrine, a mydriatic (pupil dilating) agent. FDA-approved drugs containing each of these agents have been used in ophthalmological clinical practice for more than 15 years, and both are contained in generic, FDA-approved drugs.
ILR surgery involves replacement of the original lens of the eye with an artificial intraocular lens. These procedures are typically performed to replace a lens opacified by a cataract or to correct a refractive error of the lens (i.e., refractive lens exchange). OMS302 is added to standard irrigation solution used in ILR surgery and delivered intracamerally to maintain intraoperative mydriasis (pupil dilation), to prevent surgically induced miosis (pupil constriction), and to reduce postoperative pain and irritation. Maintenance of mydriasis is critical to the safety and surgical ease of the procedure. Intraoperative pupil constriction increases the risk of injury to intraocular structures and can substantially prolong surgical time.