Good news recently flowed in at
) from Europe when the European Medicines Agency (EMA) approved
the positive opinion rendered by the European Pediatrics
Committee (PDCO) related to the company's pediatric investigation
plan (PIP) for its ophthalmology candidate, OMS302.
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The approval is one of the preconditions for the submission of
the Marketing Authorization Application (MAA) for OMS302. The
company plans to submit the MAA to the EMA in mid-2013. The
company is looking to get the candidate approved for maintaining
intraoperative mydriasis (pupil dilation), prevent surgically
induced miosis (pupil constriction) and reducing postoperative
pain and irritation due to intraocular lens replacement (ILR)
surgery, including cataract surgery and refractive lens exchange.
According to the pediatric investigation plan, Omeros will
conduct a study to evaluate the safety and efficacy of OMS302 in
patients aged between 13 and 17 years. Omeros will be eligible
for an additional six months of patent exclusivity for OMS302 in
Europe following the completion of the study (under the PIP). In
Europe, currently issued patents related to OMS302 are set to
expire in 2023.
Omeros also intends to get OMS302 approved for the above
mentioned indication in the US. The company plans to submit the
New Drug Application (NDA) to the US Food and Drug Administration
(FDA) shortly. Omeros expects to seek US approval for the
candidate before the MAA submission. Omeros is planning to seek
pediatric exclusivity in the US as well.
Currently, the ophthalmology market is dominated by players like
Omeros, a biopharmaceutical company, at present carries a Zacks
Rank #4 (Sell). Biopharma stocks such as
), carrying Zacks Rank #1 (Strong Buy), currently look