Omeros Corp said the U.S. Food and Drug Administration had approved its drug for use in cataract and lens replacement surgeries, the first drug developed by the company to get marketing clearance from the regulator.
Omeros, whose shares shot up 11 percent to $13 in premarket trading, said it plans to launch the drug, Omidria, later this year in the United States.
Wedbush analyst Liana Moussatos said she expects the drug to be launched by Sept. 30 and raised her price target on the company's stock to $44 from $37.
Omeros will likely generate revenue of about $7.2 million this year, Moussatos wrote in a note on Monday.
The analyst estimated gross peak annual sales of about $500 million for Omidria in 2019.
The drug could cost $200-$250 per bottle, Needham & Co analyst Serge Belanger told Reuters.
Omidria — a formulation of the pupil-dilating agent, phenylephrine, and anti-inflamatory ketorolac — works by maintaining pupil size and reducing post-operative pain in adult patients.
The drug 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.
About 3.8 million intraocular lens replacement procedures were performed in the United States, and about 22 million worldwide, this year according to the company's website.
The company said it received the 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.
(Reporting by Natalie Grover in Bangalore; Editing by Joyjeet Das)