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Omeros' Omidria Gets FDA Nod

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Omeros Corporation’s (OMER) Omidria 1%/0.3% has been approved by the U.S. Food and Drug Administration (:FDA) for reducing postoperative pain during cataract surgery or intraocular lens replacement (:ILR) and maintaining pupil size by preventing intraoperative miosis (pupil constriction).

Importantly, the company need not fulfill any post-marketing commitments. The company intends to launch Omidria in the U.S. later this summer or in early fall. Omidria is under regulatory review in the EU for the same indication. Omeros plans to launch the drug in the EU (if approved) later this year or in the first half of 2015.

With FDA approval, Omidria becomes Omeros’ first approved drug and also the only approved product for intraocular use for the prevention of intraoperative miosis and reduction of postoperative pain related to ophthalmic surgeries.

Meanwhile, Omeros is planning to conduct pediatric studies on Omidria. Pediatric approval would provide Omeros with an additional six months of exclusivity.

Additionally, the company is studying Omidria for the management of intraoperative floppy iris syndrome (:IFIS).

The approval of Omidria is a major positive for Omeros. Meanwhile, we are encouraged by the pipeline progress at Omeros. While OMS103 is under phase III studies for the reduction of inflammatory pain following arthroscopic partial meniscectomy, OMS824 (schizophrenia and Huntington’s disease) and OMS721 (thrombotic microangiopathies (TMAs)) are in phase II studies.

OMS824 has orphan drug status in the U.S. for Huntington’s disease and Fast Track status for the treatment of cognitive impairment in patients suffering from the disease. Additionally, the company is looking to get Fast Track status for OMS824 for the treatment of schizophrenia. OMS721 also has orphan drug status in the U.S. for the inhibition of complement-mediated TMAs.

Omeros carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Cardica Inc. (CRDC), Eagle Pharmaceuticals Inc. (EGRX) and ICU Medical, Inc. (ICUI). All these stocks carry a Zacks Rank #2 (Buy).

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