Omeros Corporation is a clinical-stage biopharmaceutical company. It is engaged in discovering, developing and commercializing products focused on inflammation and disorders of the central nervous system.
Omeros shares spike on successful phase 3 trial for lens replacement surgery drug
The phase three, placebo-controlled trial investigated the drug for the treatment of patients undergoing intraocular lens replacement surgery.
On the Nasdaq Exchange, shares of the company rose 22.12 percent to $9.33, as of 9:45 am EDT.
The OMS302 drug met its primary endpoint, by demonstrating a statistically significant maintenance of intraoperative mydriasis, or pupil dilation. OMS302 also demonstrated "superior pain reduction", the study's secondary endpoint, compared to placebo.
"This is an important day for Omeros," said CEO, Dr. Gregory A. Demopulos.
"This achievement marks our transition to a company preparing, rather than hoping, to commercialize our first product. Following our recent successful meetings with U.S. and European regulators, we plan to begin enrolling patients in our second Phase 3 trial early next month and to submit marketing applications in both the U.S. and Europe in the first part of 2013."
The OMS302 drug consists of a combination of an anti-inflammatory active pharmaceutical ingredient (API) and an API that causes pupil dilation. Each API involved has well-known safety and pharmacologic properties, Omeros said.
During the multi-centre, double-blind, phase three trial, 405 patients were randomized to receive either the OMS302 drug or a placebo. The drug, or placebo, was added to the standard irrigation solution during the surgery, in order to maintain mydriasis and reduce post-operative pain.
Director of glaucoma and cataract at the Moran Eye Center of the University of Utah, Dr. Alan S. Crandall, said: "The data from this study are compelling and demonstrate that OMS302 addresses a universal need in lens replacement surgery.
"Ophthalmologic surgeons are committed to successful outcomes for their patients, and maintenance of mydriasis and pain management are central to that success. Given the drug's demonstrated effects on these two challenges facing all lens replacement surgeons, I expect that OMS302 could become widely used."
Based in Seattle, Washington, the clinical-stage biopharmaceutical company focuses on products aimed at inflammation, bleeding and disorders of the central nervous system.
Omeros uses its PharmacoSurgery platform, which is designed to deliver low-dose drugs directly to the surgical site, pre-emptively reducing inflammation and other problems caused by surgery.