FDA approves Omeros eye drug, shares rise

[June 02, 2014]  (Reuters) - Omeros Corp said the U.S. Food and Drug Administration had approved its drug for use in cataract and lens replacement surgeries, making it the company's first drug to be approved by the regulator.

Omeros, whose shares were up 10 percent in premarket trading, said it plans to launch the drug, Omidria, later this year in the United States.

The drug works by maintaining pupil size and reducing post-operative pain in adult patients.

Omidria is the only FDA-approved product for this use in lens replacement surgeries — one of the most common surgeries in the United States, Omeros said on Monday.

The company said it received regulatory consent without any post-marketing commitments other than a previously agreed study of the drug's use in pediatric patients.

The European Medicines Agency is reviewing the company's marketing application for Omidria, Omeros said.

The Seattle, Washington-based company's stock closed at $11.69 on the Nasdaq on Friday.

(Reporting by Natalie Grover in Bangalore; Editing by Joyjeet Das)

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