Drug news
Posiive Phase III results for OMS302 (Omeros Corp) in Cataract Surgery
A Phase III clinical trial evaluated OMS302, from Omeros Corporation, in patients undergoing intraocular lens replacement surgery has met its primary endpoint by demonstrating statistically significant 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. the trial enrolled 405 patients randomized 1:1 to receive either oms302 or placebo. added to standard irrigation solution used during ophthalmological procedures oms302 is omeros proprietary pharmacosurgery product designed to maintain intraoperative mydriasis and reduce postoperative pain and irritation resulting from cataract and other lens replacement surgery.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 less than 0.05 in a series of other clinically relevant measures. in this study oms302 was well-tolerated.>