) is looking to get its pipeline candidate, Omidria (OMS302),
approved in the U.S. and EU for the treatment of patients
undergoing intraocular lens replacement (ILR) surgery. Omidria is
Omeros' proprietary pharmacosurgery product.
Omeros recently reported analyses of phase III data on Omidria
at the Annual American Academy of Ophthalmology (AAO).
Data revealed that Omidria reduced the occurrence of
intraoperative pupil constriction (miosis). It was demonstrated
that pupil constriction of at least 3 millimeters was common in
control patients while constriction greater than 1 millimeter was
uncommon in Omidria treated patients.
We remind investors that Omidria was filed for approval in the
U.S. and EU in Jul and Sep 2013, respectively. In Oct 2013, the
new drug application for Omidria was accepted for review by the
Food and Drug Administration. The marketing authorization
application in the EU was validated by the European authorities
in the same month. Omeros expects to launch Omidria in the second
half of 2014, assuming approval.
Omeros expects to commence an expansion study by the end of
the year to include a subset of ILR patients who have a history
of using alpha adrenergic antagonists, such as, Flomax
(tamsulosin), indicated for intraoperative floppy iris syndrome
We are encouraged by Omeros' progress on Omidria. The
ophthalmology market is currently dominated by players like
Omeros, a biopharmaceutical company, at present carries a
Zacks Rank #3 (Hold). Biopharma stocks such as
), carrying a Zacks Rank #1 (Strong Buy), currently look more
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