) 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
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
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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