) has progressed well with its ophthalmology candidate, OMS302.
Earlier in the month, the U.S. Food and Drug Administration (FDA)
agreed to the Pediatric Study Plan (PSP) on the candidate.
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The PSP was proposed by Omeros to evaluate OMS302 in pediatric
patients undergoing primary cataract extraction. The U.S.
regulatory body also notified that if the PSP is successfully
completed, OMS302 will be eligible for an additional six months
of marketing exclusivity in the U.S.
We remind investors that the European Medicines Agency has
already approved Omeros' Pediatric Investigation Plan to study
the candidate in pediatric patients, which may lead to an
additional marketing exclusivity in Europe as well.
The pediatric studies, both in the U.S. and the EU, are expected
to begin in 2014. Omeros expects results from these pediatric
studies during the post-marketing period.
Omeros had submitted regulatory applications both in the U.S. and
EU for OMS302 earlier in the year. The company is looking to get
OMS302 approved for the treatment of patients undergoing
intraocular lens replacement (ILR) surgery. The company expects
OMS302 to be available in both U.S. and Europe by next year.
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 are encouraged by Omeros' progress with OMS302. The
ophthalmology market is currently dominated by players like
Omeros, a biopharmaceutical company, at present carries a Zacks
Rank #4 (Sell). Biopharma stocks such as
), carrying a Zacks Rank #1 (Strong Buy), currently look more