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Omeros' OMS302 Filed in the EU

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Omeros Corporation (OMER - Free Report) recently submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for OMS302 to treat patients undergoing intraocular lens replacement (ILR) surgery.

We note that OMS302 is added to standard irrigation solution used during ILR. The candidate has proved to be clinically meaningful and statistically significant in the maintenance of intraoperative mydriasis (pupil dilation), prevention of intraoperative miosis (pupil constriction) and reduction of postoperative ocular pain.

We remind investors that earlier the EMA has granted eligibility for centralized review for OMS302. In Jul 2013, the EMA approved the positive opinion rendered by the European Paediatrics Committee (PDCO) related to the company’s paediatric investigation plan (PIP) for OMS302. The approval was one of the preconditions for the submission of the MAA for OMS302.

Furthermore, last month Omeros announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of OMS302 to treat patients undergoing ILR surgery.  

Omeros believes that OMS302 will be available both in the U.S. and the EU in the second half of next year (assuming approval in both U.S. and the EU).

We are encouraged by Omeros’ progress with its ophthalmology candidate, OMS302. However, the ophthalmology market is currently dominated by players like Allergan Inc. (AGN - Free Report) and Novartis (NVS - Free Report) .

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


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