Omeros' Ophthalmology Product OMS302 Achieves Co-Primary Endpoints in Phase 2b Clinical Study
SEATTLE, March 23, 2011 /PRNewswire via COMTEX/ --
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(TM) 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 (p=0.0418) pain in the early postoperative period and reduced the frequency of complaints of moderate and severe pain (2.5 times more complaints in the vehicle-treated patients). The drug product was safe and well tolerated in this study.
"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."
About the Phase 2b Study of OMS302
This multicenter, randomized, double-blind, vehicle-controlled Phase 2b clinical trial included 221 patients. To achieve the trial's full-factorial design, patients were randomized into one of four parallel treatment groups. The first arm (n=55) received OMS302, the second arm (n=55) received only the mydriatic agent in OMS302 (OMS302-mydriatic), the third arm (n=54) received only the anti-inflammatory agent in OMS302 (OMS302-anti-inflammatory) and the fourth arm (n=57) received standard irrigation solution without drug. The co-primary endpoints of the study included maintenance of mydriasis (pupil dilation) and reduction of postoperative ocular pain. Patients in the OMS302 group demonstrated statistically significant maintenance of mydriasis over both the OMS302-anti-inflammatory (p<0.0001) and vehicle-treated (p<0.0001) groups. Similarly, the OMS302-treated group demonstrated a statistically significant reduction in pain compared with both the OMS302-mydriatic (p=0.0089) and vehicle-treated (p=0.0418) groups, demonstrating that each component of OMS302 contributed to the efficacy of the product. OMS302 was safe and well tolerated in this study. The complete Phase 2b data set will be presented and published at a later date.
OMS302 is Omeros' proprietary PharmacoSurgery(TM) 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 pupil dilation (mydriasis), 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 15years, and both APIs are contained in generic, FDA-approved drugs.
About Ophthalmological Procedures (Cataract and Other Lens Replacement Surgery)
Approximately threemillion cataract operations are performed in the United States each year, and that number is expected to increase as the U.S. population ages. Cataract and other lens replacement procedures involve replacement of the original lens of the eye with an artificial intraocular lens. These operations are typically performed to replace a lens opacified by a cataract or to correct a refractive error of the lens. Pupil dilation is an essential prerequisite for these procedures and, if not maintained throughout the surgical procedure or if miosis occurs, the risk of injuring structures within the eye increases and the required operating time is often prolonged.
About Omeros Corporation
Omeros is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation, bleeding and disorders of the central nervous system. The Company's most clinically advanced product candidates are derived from its proprietary PharmacoSurgery(TM) platform designed to improve clinical outcomes of patients undergoing a wide range of surgical and medical procedures. Omeros has six ongoing clinical development programs, including four from its PharmacoSurgery(TM) platform, the most advanced of which is in a Phase 3 clinical program, and two from its addiction franchise. 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, bleeding 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 potential benefits of OMS302; the expected increase in the number of cataract operations performed in the United States; and that Omeros may have 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 15, 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