Sign up USA
Proactive Investors - Run By Investors For Investors

Omeros shares spike on successful phase 3 trial for lens replacement surgery drug

Omeros shares spike on successful phase 3 trial for lens replacement surgery drug

Omeros (NASDAQ:OMER) saw its stock rise more than 22 percent Tuesday morning, following news that its OMS302 drug achieved both primary and secondary goals in a phase three study.

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.



Register here to be notified of future OMER Company articles
View full OMER profile

Omeros Timeline

Related Articles

shutterstock_152199281_56fd078fe84f7.jpg
March 31 2016
Amryt Pharmaceuticals is coming to the market following a reverse takeover deal with the investment firm Fastnet Equities. Here boss Joseph Wiley tells us a little bit more about the AIM newcomer.
sareum-test-tubes.png
March 10 2016
November saw the Finland-based life sciences firm list on the London Exchange, raising €14.2mln.
Heart-cells.jpg
April 13 2016
Jim Phillips, Midatech’s chief executive, said Zuplenz offers relief from some of the most debilitating side-effects of common cancer treatments. Generically called ondansetron, the oral soluble film eases the problem of gritty residue, having to wear a patch and sedative side effects of dissolving tablets and injections.
Copyright © Proactiveinvestors.com, 2016. All Rights Reserved - Proactive Investors North America Inc., Proactive Investors LLC