Wednesday, 11 April 2012

Patient Enrolment has begun in Omeros Corportation


Omeros Corporation introduced that in fact patient enrollment has begun inside the Company's second Phase 3 clinical trial assessing OMS302 in intraocular lens replacement (ILR) surgery. OMS302, certainly one of Omeros' valuable PharmacoSurgery™ products, is included in typical irrigation solution utilized during ILR procedures to preserve intraoperative mydriasis (pupil dilation) and lower postoperative pain. In the initial Phase 3 clinical trial of OMS302, the medication product proved statistically major dominance over placebo in maintaining intraoperative mydriasis and reduces postoperative pain.

Just like the initial Phase 3 clinical trial, all of this second Phase 3 trial will enroll about 400 affected individuals going through cataract operations or refractive lens exchange. Randomized, double-blind, placebo-controlled and multicenter, this unique trial will consider exactly the same efficacy and safety measures because the earlier successful Part 2b and Phase 3 research studies. Data are required within the second half of 2012.

"Offered the strength and uniformity of a typical data coming from the earlier Phase 2b and Phase 3 clinical trials of OMS302, we examine forward to reporting outcome from our second Phase 3 trial later in 2012," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "Our prior OMS302 trials attending immediately and we count on a similar enrollment ratio within this trial. Now we have begun organizing our NDA and, assuming constructive data, are targeting an entry date to begin with part of 2013."

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