SEATTLE, Nov. 29, 2011 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that it has submitted to the European Medicines Agency (EMA) a letter of intent to file its Paediatric Investigation Plan (PIP) for OMS302, the Company's product candidate for use during intra-ocular lens replacement surgery. A PIP is part of the EMA approval process and must be agreed prior to submission of a Marketing Authorization Application (MAA) for the drug in the European Union, unless the requirement is waived. A PIP describes how a company intends to evaluate the use of a given drug in children. Completion of studies outlined in the PIP prior to EU approval is not a requirement for MAA submission.
OMS302 is being evaluated in a Phase 3 clinical program enrolling both cataract surgery and refractive lens exchange patients. The drug is added to standard irrigation solution used during cataract and other lens replacement surgery to maintain intraoperative mydriasis (pupil dilation) and reduce postoperative pain. Two randomized, double-blind, placebo-controlled, multicenter trials are planned. The first trial is underway in North America, and data are expected in the first quarter of 2012. Omeros plans to initiate the second trial following discussions with regulators to ensure that data collected meet European expectations for marketing approval. The co-primary endpoints for these trials – maintenance of intraoperative pupil dilation (mydriasis) and reduction of postoperative pain – are the same as those achieved in the recently completed 221-patient Phase 2b trial. In that study, OMS302 was significantly superior to vehicle both in reducing postoperative pain and maintaining mydriasis.
"We remain on track to announce data from the initial Phase 3 trial of OMS302 in the first quarter of 2012," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "While that trial advances, we are in discussions with regulators in the United States and Europe so that we will be poised to file marketing applications as soon as possible following receipt of data, should they be positive."
Omeros' OMS302 Program
OMS302 is Omeros' PharmacoSurgery™ product candidate being developed for use during ophthalmological procedures including cataract and other lens replacement surgery. OMS302 is a proprietary combination of an anti-inflammatory active pharmaceutical ingredient (API) and an API that causes mydriasis (pupil dilation), each with well-known safety and pharmacologic profiles. FDA-approved drugs containing each of these APIs have been used in ophthalmological clinical practice for more than 15 years, and both APIs are contained in generic, FDA-approved drugs.
In a 221-subject Phase 2b clinical trial that evaluated OMS302 in patients undergoing cataract surgery, OMS302 demonstrated clinically meaningful and statistically significant benefits in both prespecified co-primary endpoints – maintenance of intraoperative mydriasis and reduction of pain in the early postoperative period. Also, fewer OMS302-treated subjects reported moderate and severe postoperative pain. In that study, OMS302 was safe and well tolerated without evidence of drug-related adverse events.
About Omeros Corporation
Omeros is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products targeting inflammation, coagulopathies and disorders of the central nervous system. The Company's most clinically advanced product candidates are derived from its proprietary PharmacoSurgery™ platform designed to improve clinical outcomes of patients undergoing a wide range of surgical and medical procedures. Omeros has four ongoing clinical development programs. Omeros may also have the near-term capability, through its GPCR program, to add a large number of new drug targets and their corresponding compounds to the market. Behind its clinical candidates and GPCR platform, Omeros is building a diverse pipeline of protein and small-molecule preclinical programs targeting inflammation, coagulopathies and central nervous system disorders.
This press release contains forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995, which are subject to the "safe harbor" created by those sections. These statements include, but are not limited to, statements regarding the Company's expectations that data from the first Phase 3 trial of OMS302 will be available during the first quarter of 2012, that Omeros will initiate a second Phase 3 trial of OMS302 following discussions with regulators, that Omeros will be poised to file marketing applications as soon as possible following receipt of OMS302 Phase 3 clinical data , and that Omeros may have the near-term capability, through its GPCR program, to add a large number of new drug targets and their corresponding compounds to the market. Forward-looking statements are based on management's beliefs and assumptions and on information available to management only as of the date of this press release. Omeros' actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, the risks, uncertainties and other factors described under the heading "Risk Factors" in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 8, 2011. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements publicly, even if new information becomes available in the future.
SOURCE Omeros Corporation
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