Omeros Corporation (OMER) 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 (:IFIS).
Omeros, a biopharmaceutical company, at present carries a Zacks Rank #3 (Hold). Biopharma stocks such as Actelion Ltd. (ALIOF), carrying a Zacks Rank #1 (Strong Buy), currently look more attractive.