Positive data from Omeros' OMS302 Phase 2b trial in patients undergoing cataract surgery

Mar 23 2011

Omeros Corporation (Nasdaq: OMER), a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation, bleeding and disorders of the central nervous system, today reported positive data from a Phase 2b clinical trial evaluating OMS302 in patients undergoing cataract surgery.  OMS302, added to standard irrigation solution used during ophthalmological procedures, is Omeros' proprietary PharmacoSurgery™ product in development to maintain intra-operative mydriasis (pupil dilation) and reduce postoperative pain and irritation resulting from cataract and other lens replacement surgery.

In this 221-patient Phase 2b clinical study, subjects treated with OMS302 demonstrated statistically significant (p<0.0001) and clinically meaningful maintenance of mydriasis throughout the cataract procedure. If mydriasis is not maintained throughout the procedure, the risk of injuring structures within the eye increases and the required operating time is often prolonged. Of equal clinical relevance, OMS302 also significantly decreased>

"These data are compelling and could represent a major advance for lens replacement procedures, including cataract surgery and refractive lens exchange.  OMS302 has the ability to facilitate the ease of the procedure while improving patient outcomes and safety," stated Alan S. Crandall, M.D., director of glaucoma and cataract, senior vice chairman of ophthalmology and visual sciences at the Moran Eye Center, University of Utah, and the immediate past president of the American Society of Cataract and Refractive Surgery.

"Maintenance of mydriasis is critical to performing lens exchange safely and proficiently.  In addition to the significant mydriatic benefit of OMS302 seen in this study, the reduction in pain reported by OMS302-treated patients is clinically important," stated Mark I. Rosenblatt, M.D., Ph.D., associate professor of ophthalmology, Weill Cornell Medical College. "Because OMS302 is administered through the irrigation solution currently used during lens exchange, the drug product fits readily into the workflow of the operating room and does not require a change in the surgeon's routine procedure."

"We are pleased that OMS302 demonstrated statistically significant and clinically relevant benefits in this full-factorial Phase 2b study," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "Each component of the drug product showed clear efficacy. Given the strength and consistency of these clinical data, we have begun preparations for a pivotal Phase 3 program."