Good news recently flowed in at Omeros Corporation (OMER - Free Report) 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.
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 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 Jazz Pharmaceuticals (JAZZ - Free Report) , carrying Zacks Rank #1 (Strong Buy), currently look attractive.