Omeros will be 20 years old as a company next year, and it hopes to celebrate that milestone by getting the go-ahead to start selling its first new drug.
Seattle-based Omeros (NASDAQ: OMER) said today it has filed an application to the FDA for clearance to start selling OMS302, an experimental drug to help people undergoing eye surgery to correct cataracts or getting a procedure called refractive lens exchange. The company said it plans to turn in another application to European regulators before the end of September.
The Omeros drug is a combination of ketorolac, an anti-inflammatory drug, and phenylephrine, a mydriatic (pupil dilating) agent. Quite a few patients could be candidates for the new combo treatment, as about 3.6 million cataract and refractive lens exchanges (also called intraocular lens replacement procedures) are done each year in the U.S., Omeros has said. Omeros has gathered data from a pair of placebo-controlled studies of more than 400 patients, which showed the combination therapy maintained pupil dilation during surgery and reduced pain following surgery.
“OMS302 fills a need recognized by all ophthalmic surgeons and does so without requiring them to change their routine operating procedures,” said Eric Donnenfeld, a clinical professor of ophthalmology at New York University and president of the American Society of Cataract and Refractive Surgery, in a company statement.
Simos Simeonidis, an analyst with Cowen & Company, said in a note to clients that he expects the drug to win FDA approval and be on the U.S. market in 2014. He didn’t offer a specific sales forecast for the product. “Omeros is moving towards commercialization and risk reduction, and to transitioning from a purely R&D company to a mix of R&D and revenue generation,” he wrote.
Omeros shares climbed 3.5 percent to $5.55 at 3 pm Eastern time following the news.