Omeros Passes 2nd Trial for Eye Drug, Preps for FDA Push

11/5/12Follow @xconomy

Seattle-based Omeros (NASDAQ: OMER) has spent 18 years as an R&D company, and now it can say that some of that biomedical research and development is being translated into what looks like a marketable product.

The company said today it passed the second of two pivotal clinical trials with its experimental drug for use in eye surgeries. Omeros said the new drug met the two main goals of maintaining pupil dilation and reducing pain in the early period after surgery. The findings, from a placebo-controlled study of 416 patients, confirmed results from a separate study of 405 patients released in March. Omeros said it will package data from the two trials together in an application to the FDA to start marketing OMS302 in the first half of 2013, and to European Union regulators in mid-2013.

Omeros said the drug’s benefit over placebo was highly statistically significant—meaning it was unlikely due to chance. But Omeros didn’t say in today’s statement how much longer its drug kept eyes dilated, how much it reduced pain, or how much its product reduced long-term complications from surgery. The drug did appear well-tolerated, but researchers will need to keep following patients until January to do the final analysis on safety. Detailed results are expected to be released at an upcoming medical meeting, and in a peer-reviewed journal, Omeros said.

If the product passes regulatory scrutiny on schedule in 2014, then Omeros would be in position to start marketing its first product on its 20th anniversary as a company. The company has been staffing up to prepare for that milestone, recently hiring new vice presidents of regulatory affairs and clinical development.

The Omeros drug is a combination of ketorolac, an anti-inflammatory drug, and phenylephrine, a mydriatic (pupil dilating) agent that have been part of FDA-approved compounds used by ophthalmologists for more than a decade. The Omeros combo is designed to be used for intraocular lens replacement surgery, which can be done to correct cataracts, or what’s known as a refractive lens exchange—an alternative to Lasik corrective vision surgery. About 3.6 million intraocular lens replacement procedures are expected in the U.S. this year, Omeros said.

Alan Crandall, the senior vice chairman of ophthalmology and visual sciences at the Moran Eye Center at the University of Utah, said in an Omeros statement that, “I expect that OMS302 will represent a significant and widely used advance in the practice of ophthalmologic surgeons who perform intraocular lens replacement, improving both surgical ease and patient outcomes.”

“It’s an understatement to say we’re excited by the results of this second Phase 3 trial,” CEO Greg Demopulos said on a conference call with investors this morning. He added: “We’re becoming a commercial company.”

Omeros stock climbed 8 cents to $9.45 a share at 12:43 pm Eastern time, following the news.

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