Omeros has reported positive data from its phase III 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. The data for both endpoints are clinically meaningful. OMS302, added to standard irrigation solution used during ophthalmological procedures, 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 multicenter, double-blind, phase III clinical trial enrolled 405 patients randomized 1:1 to receive either OMS302 or the placebo. The primary endpoint was maintenance of intraoperative mydriasis (pupil dilation), 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 the 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.
"Maintenance of mydriasis throughout the procedure is essential for the safety of lens replacement surgery," stated Mark I. Rosenblatt, M.D., Ph.D., associate professor of ophthalmology, Weill Cornell Medical College. "A constricted pupil decreases the surgeon's operative field, which can make the procedure more difficult to perform and potentially increases the rates of complications, including rents in the lens capsule or the retention of cortical lens material with more frequent posterior capsular opacification or lens dislocation."
"This achievement marks our transition to a company preparing, rather than hoping, to commercialize our first product," said Gregory A. Demopulos, M.D., chairman and CEO, Omeros. "Following our recent successful meetings with U.S. and European regulators, we plan to begin enrolling patients in our second phase III trial early next month and to submit marketing applications in both the U.S. and Europe in the first part of 2013."
Complete data from the phase III trial is expected to be presented at an upcoming major ophthalmology meeting, as well as in a leading peer-reviewed ophthalmology journal.