Oct. 3, 2012
/PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that the last patient has been enrolled in the Company's second Phase 3 clinical trial evaluating OMS302 for use during intraocular lens replacement (ILR) surgery. 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. Maintenance of mydriasis is critical to the safety and surgical ease of the procedure, while intraoperative pupil constriction increases the risk of injury to intraocular structures and can substantially prolong surgical time.
In its first Phase 3 clinical trial, OMS302 demonstrated statistically significant superiority over placebo in maintenance of intraoperative mydriasis (p<0.00001) and reduction of postoperative pain (p<0.00001). The second Phase 3 clinical trial, which was the same size (approximately 400 patients) as the first Phase 3 trial, is evaluating the same efficacy and safety measures as the earlier successful Phase 2b and Phase 3 clinical trials.
"We have already begun assembling the NDA and MAA for OMS302 and, assuming positive results from the second trial, expect to file these marketing applications with U.S. and European regulators in the first half of 2013," said
Gregory A. Demopulos
, M.D., chairman and chief executive officer of Omeros. "We look forward to unlocking and releasing top-line data from our second Phase 3 OMS302 clinical trial later this quarter followed, prior to year end, by Phase 3 data from our OMS103HP program and Phase 1 data from our PDE10 program."
About Omeros' OMS302 Program
OMS302 is Omeros' 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.