Second Phase 3 Study of OMS302 for Intraocular Lens Replacement Surgery
Omeros announced that patient enrollment has begun for its second Phase 3 trial for OMS302 in intraocular lens replacement (ILR) surgery.
In the first Phase 3 trial, OMS302 demonstrated statistically significant superiority over placebo in maintenance of intraoperative mydriasis (p<0.00001) and reduction of postoperative pain (p<0.00001). This second Phase 3 trial will be a randomized, double-blind, placebo-controlled, multicenter trial enrolling approximately 400 patients undergoing cataract surgery or refractive lens exchange. This trial will evaluate the same efficacy and safety measures as the earlier successful Phase 2b and Phase 3 clinical trials. Data are expected in the second half of 2012.
OMS302 is a combination of ketorolac, an anti-inflammatory agent, and phenylephrine, a mydriatic (pupil dilating) agent. OMS302, added to standard irrigation solution used during ophthalmological procedures, is designed to maintain intraoperative mydriasis and reduce postoperative pain and irritation resulting from cataract and other lens replacement surgery.
For more information call (206) 676-5000 or visit www.omeros.com.