Omeros has some news out this morning on one of the lesser-known members of its drug development pipeline.
The Seattle-based biotech company (NASDAQ: OMER) said today that its experimental treatment for patients undergoing eye surgery to correct cataracts was safe, able to maintain pupil dilation during the procedure, and reduce postoperative pain and irritation. The results—which Omeros said will be published and presented later in a scientific forum—were from a study of 221 patients that randomly assigned people to a control group, the Omeros combination product, or its two individual components. Based on the results, the company said it now plans to take the drug, OMS302, into the third and final stage of clinical trials normally required for FDA approval.
The findings are important for Omeros, giving something to potentially stir interest among investors. The company, which went public at $10 a share in October 2009, has been stuck in the doldrums, closing at $6.05 yesterday. Omeros pitched investors on the promise of an anti-inflammatory solution for knee surgeries that has been in pivotal testing for several years, although it still hasn’t presented final results. At a much earlier stage, Omeros has talked up the promise of its initiative to discover new drug targets, known as GPCRs, which it hopes will entice Big Pharma companies to form partnerships. That program is supported by $25 million from Paul Allen and Washington state’s Life Sciences Discovery Fund.
Omeros’ cataract program, by comparison, has gotten little attention. The market for a new drug could potentially be quite big, as there are about 3 million surgeries in the U.S. each year to correct vision impairments from cataracts, and the number is expected to climb as Baby Boomers get older.
Here’s what the study was about, based on Omeros’ statement this morning. Omeros developed a proprietary combination of two generic drugs that have been used by ophthalmologists for more than 15 years in irrigation solutions. One component minimizes inflammation, and one causes pupil dilation. The pupil dilation part is important because if it isn’t maintained throughout the procedure, then risks of injury during surgery go up.
The study showed that pupil dilation was maintained through cataract surgery, and that fewer people complained afterwards about moderate to severe pain, Omeros said. Both findings were statistically significant. Omeros didn’t say how much better the combo was than its individual components—a key point it will have to delineate if it is going to convince doctors to use a brand-name combination drug instead of a cheap generic one.
One prominent eye specialist quoted by Omeros today in its statement sound bullish. “These data are compelling and could represent a major advance for lens replacement procedures, including cataract surgery and refractive lens exchange. OMS302 has the ability to facilitate the ease of the procedure while improving patient outcomes and safety,” said Alan Crandall, director of glaucoma and cataract, senior vice chairman of ophthalmology and visual sciences at the Moran Eye Center at the University of Utah.
Taking this latest program into pivotal trials certainly won’t be cheap, and Omeros doesn’t have unlimited resources. The company said it ended 2010 with $42 million in cash in the bank, down from $60.3 million a year earlier. With a depressed stock price, it’s no easy thing to raise more money, so it will be interesting to see if investors find this eye surgery solution compelling enough to help finance it all the way to FDA approval.