Phase 3 Study Update of OMS302 for Intraocular Lens Replacement Surgery
Omeros reported positive data from the second of its two pivotal Phase 3 clinical trials evaluating OMS302 in patients undergoing intraocular lens replacement surgery.
This multicenter, double-blind, Phase 3 clinical trial enrolled 416 patients randomized 1:1 to receive either OMS302 or placebo. In this trial, OMS302 met its co-primary endpoints by demonstrating statistically significant (P<0.00001) maintenance of intraoperative mydriasis (pupil dilation) and statistically significant (P=0.0002) reduction of pain in the early postoperative period. Mydriasis is critical to the safety and surgical ease of lens replacement surgery as intraoperative pupil constriction increases the risk of injury to intraocular structures and can substantially prolong surgical time. OMS302 also achieved statistical significance in other clinically relevant measures. The results from this trial are consistent with those from Omeros' first OMS302 Phase 3 and earlier Phase 2b clinical trials.
OMS302 is a combination of ketorolac, an anti-inflammatory agent, and phenylephrine, a mydriatic agent. OMS302 is added to standard irrigation solution used during ophthalmological procedures.
For more information call (206) 676-5000 or visit www.omeros.com.