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Omeros product meets co-primary endpoints in phase 3 trial
OMS302 met the co-primary endpoints of maintenance of intraoperative mydriasis and reduction of pain in patients undergoing IOL replacement surgery in a second phase 3 clinical trial, according to a news release from Omeros.
The multicenter, double-masked trial analyzed 416 subjects randomized to receive either OMS302, a proprietary combination of ketorolac and phenylephrine, or placebo.
OMS302 demonstrated statistically significant maintenance of pupil dilation (P < .00001) and statistically significant reduction in pain in the early postoperative period (P = .0002), according to the release.
The product has been well tolerated throughout several trials, and no safety concerns have been noted, the release said. A final review of safety data will occur after the last safety assessment in January. In 2013, a new drug application will be submitted to the U.S. Food and Drug Administration and a marketing authorization application will be submitted to the European Medicines Agency.
Company officials anticipate a market launch for OMS302 in 2014.