Omeros Corporation (OMER - Free Report) 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.
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 Allergan Inc. (AGN - Free Report) and Novartis (NVS - Free Report) .
Omeros, a biopharmaceutical company, at present carries a Zacks Rank #4 (Sell). Biopharma stocks such as Actelion Ltd. , carrying a Zacks Rank #1 (Strong Buy), currently look more attractive.