Phase 3 Trial Update of OMS302 for Intraocular Lens Replacement Surgery
Omeros reported positive data from its Phase 3 clinical trial evaluating OMS302 in patients undergoing intraocular lens replacement surgery. OMS302 met its primary endpoint by demonstrating statistically significant (P<0.00001) maintenance of intraoperative mydriasis (pupil dilation). OMS302 also demonstrated statistical superiority (P<0.00001) over placebo in reduction of pain in the early postoperative period.
This multicenter, double-blind, clinical trial enrolled 405 patients randomized 1:1 to receive either OMS302 or placebo. The primary endpoint was maintenance of intraoperative mydriasis (pupil dilation), which is critical to the safety and surgical ease of lens replacement surgery. Pupil constriction during surgery increases the risk of injury to intraocular structures and can substantially prolong surgical time. In addition to statistical superiority over placebo in maintenance of mydriasis and the secondary endpoint of reduced postoperative pain, OMS302 achieved P values of <0.05 in a series of other clinically relevant measures.
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.