Just about a year after watching a late-stage study for its post-surgery knee therapy go down in flames, Seattle-based Omeros turned in positive Phase III data for its ophthalmology treatment. The biotech announced this morning that OMS302 met its primary endpoint by demonstrating statistically significant pupil dilation and a reduction of pain for patients who had undergone lens replacement surgery.
The data puts Omeros on track to launching a second Phase III study as it lays the groundwork for new drug applications in the U.S. and Europe in 2013. And that news encouraged investors to bid up Omeros' shares ($OMER) as much as 30% this morning.
Pupil dilation is a significant factor during lens replacement surgery. The risk of injury increases without proper dilation and that can also significantly add to the amount of time patients spend in surgery. Omeros held back specific data from the study, noting that it will be offered up in a future scientific conference.
"This is an important day for Omeros. This achievement marks our transition to a company preparing, rather than hoping, to commercialize our first product," stated Omeros CEO Gregory Demopulos. "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."
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