FDA approves Omeros eye
drug, shares rise
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[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
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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