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Omeros Announces Positive OMS302 Safety Data in Phase 3 Clinical Trial
Date:1/22/2013

d the probability of adverse side effects," stated Gregory A. Demopulos , M.D., chairman and chief executive officer of Omeros. "Together with the strong and consistent efficacy data observed throughout its clinical development program, we believe that OMS302 represents a significant advance in lens replacement surgery, and our NDA and MAA are progressing well. We also expect to read out data from our OMS824 multiple-dose pharmacokinetic clinical trial later this quarter and to begin our second OMS103HP meniscectomy Phase 3 trial next quarter."

About Omeros' OMS302 Program
OMS302 is Omeros' product being developed for use during intraocular lens replacement (ILR) surgery, including cataract surgery and refractive lens exchange. OMS302 is a proprietary combination of ketorolac, an anti-inflammatory agent, and phenylephrine, a mydriatic (pupil dilating) agent. FDA-approved drugs containing each of these agents have been used in ophthalmological clinical practice for more than 15 years, and both are contained in generic, FDA-approved drugs.

ILR surgery 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 surgery and delivered intracamerally to maintain intraoperative mydriasis (pupil dilation), to prevent 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 Ophthalmological Procedures (Cataract and Other Lens Replacement Surgery)
There are 3.6 million intraocular lens replacement proce
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SOURCE Omeros Corporation
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