FDA Agrees with Omeros' Pediatric Study Plan for OMS302 -- Completion of Pediatric Study Can Lead to Additional Marketing Exclusivity -
SEATTLE, Oct. 15, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that the U.S. Food and Drug Administration (FDA) confirmed its agreement with the Pediatric Study Plan (PSP) proposed by Omeros to study the use of OMS302 in pediatric patients undergoing primary cataract extraction. The FDA also issued a Written Request consistent with the PSP, which means that successful completion of the PSP would make OMS302 eligible for an additional six months of marketing exclusivity in the U.S. Added to standard irrigation solution used during ophthalmological procedures, OMS302 is Omeros' proprietary PharmacoSurgery® product designed to maintain intraoperative mydriasis (pupil dilation), prevent surgically induced miosis (pupil constriction), and reduce postoperative pain resulting from cataract and other lens replacement surgery.
As announced in July, the European Medicines Agency approved Omeros' Pediatric Investigation Plan to study the use of OMS302 in pediatric patients, which is expected to lead to additional marketing exclusivity in Europe. Omeros has OMS302 marketing applications under review in the U.S. and Europe with anticipated market launch in 2014. Results of the pediatric studies are expected to be available during the post marketing period.
"The OMS302 studies in pediatric populations that have now been approved in both the U.S. and Europe are planned to begin in 2014 and, given the strength of our data in the adult population, we expect that OMS302 will show similar benefits in pediatric patients," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "With FDA's Written Request and agreement on our Pediatric Study Plan, we now have clear paths forward to obtain additional marketing exclusivity for our drug in both the U.S. and Europe. We look forward to making OMS302 available to ophthalmic surgeons and their patients in these major markets next year."
About Omeros' OMS302 Program
OMS302 is Omeros' product being developed for use during intraocular lens replacement (ILR), including cataract surgery and refractive lens exchange. OMS302 is a proprietary combination of the mydriatic (pupil dilating) agent phenylephrine and the anti-inflammatory agent ketorolac. Omeros' NDA for OMS302 has been accepted for filing by the FDA and its MAA for OMS302 has been validated by the EMA.
ILR involves replacement of the original lens of the eye with an artificial intraocular lens. These procedures are typically performed to replace a lens opacified by a cataract or to correct a refractive error of the lens (i.e., refractive lens exchange). OMS302 is added to standard irrigation solution used in ILR and delivered within the eye to maintain intraoperative mydriasis (pupil dilation), to reduce surgically induced miosis (pupil constriction), and to reduce postoperative pain and irritation. Maintenance of mydriasis is critical to the safety and surgical ease of the procedure. Intraoperative pupil constriction increases the risk of injury to intraocular structures and can substantially prolong surgical time.
About Omeros Corporation
Omeros is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics targeting inflammation, coagulopathies and disorders of the central nervous system. Derived from its proprietary PharmacoSurgery® platform, the Company's lead drug product, OMS302 for lens replacement surgery, is currently under review for marketing approval by both the US Food and Drug Administration and the European Medicines Agency with commercial launch planned for 2014. Omeros' five other clinical programs are focused on schizophrenia, Huntington's disease and cognitive impairment; addictive and compulsive disorders; complement-related diseases; and preventing problems associated with surgical procedures. Omeros also has a proprietary GPCR platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the "safe harbor" created by those sections for such statements. These statements include, but are not limited to, Omeros' expectations regarding potential additional market exclusivity for OMS302; the timing for commencement of pediatric studies in the U.S. and Europe; potential OMS302 marketing approval; potential submissions to the FDA; the availability of results of the pediatric studies; OMS302's demonstration of benefits in pediatric patients; and the date of the planned market launch of OMS302. 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 August 9, 2013. 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