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Omeros Announces Submission to European Medicines Agency of Paediatric Investigation Plan Letter of Intent for OMS302
Date:11/29/2011

xecutive 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, t
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