Omeros was battered a year ago when its lead drug candidate failed in the final stage of clinical trials, but today it is bouncing back as its second product in line passed a key test.
The Seattle-based biotech company (NASDAQ: OMER) said today that its experimental drug for use in eye surgeries met its goals of maintaining pupil dilation and relieving post-operative pain, when compared with a placebo in a pivotal trial of 405 patients. The company didn’t reveal the extent of its drug’s advantage over placebo, or the new product’s safety profile, other than to say OMS302’s edge was both statistically significant and “clinically meaningful.” Detailed results are expected to be presented at a medical meeting, and described in a peer-reviewed ophthalmology journal, Omeros said.
The Omeros drug a combination of ketorolac, an anti-inflammatory compound, and phenylephrine, a mydriatic (pupil dilating) agent that have been part of FDA-approved drugs 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. Based on the new results, Omeros plans to start enrolling patients in another Phase III trial to confirm this result, and package the data together in an application to U.S. and European regulators in the first half of 2013, in hopes of gaining clearance to start selling its first product.
The positive result for Omeros comes about a year after it stumbled with its lead drug candidate, another combination medicine that was designed to reduce inflammation and post-operative pain following knee surgery. That drug failed to meet its goals in Phase III clinical trials.
Shares of the company shot up more than 24 percent on the news, to $9.52 at 10 am Eastern today.
“The data from this study are compelling and demonstrate that OMS302 addresses a universal need in lens replacement surgery,” said Alan Crandall, the senior vice chairman of ophthalmology and visual sciences at the University of Utah’s Moran Eye Center, in an Omeros statement. Given that maintenance of pupil dilation and management of post-operative pain are challenges for the field, Crandall said, “I expect that OMS302 could become widely used.”
“This is an important day for Omeros. This achievement marks our transition to a company preparing, rather than hoping, to commercialize our first product,” said Greg Demopulos, Omeros’s CEO, in a statement.
Omeros held a conference call to discuss the news with investors this morning, and a replay is available on its website.
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