Omeros, a Seattle-based biopharmaceutical company, has commenced enrollment in a second phase III clinical trial evaluating OMS302 in 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. In the first phase IIIl 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).
Like the initial phase III trial, the second phase III trial will enroll approximately 400 patients undergoing cataract surgery or refractive lens exchange. Randomized, double-blind, placebo-controlled and multi-center, this trial will evaluate the same efficacy and safety measures as the earlier successful phase IIb and phase III clinical trials. Data are expected in the second half of 2012.
“Our previous OMS302 trials enrolled rapidly, and we expect a similar enrollment rate in this trial. We have begun preparing our NDA and, assuming positive data, are targeting a submission date in the first part of 2013,” said Gregory A. Demopulos, M.D., chairman and CEO of Omeros.
Data from the second phase III trial are expected in the second half of 2012.