Omeros

Omeros Corporation is a biopharmaceutical company that discovers, develops, and commercializes small-molecule and protein therapeutics. The company, founded in 1994 by Gregory A. Demopulos, M.D., is headquartered in Seattle, Washington, and went public in 2009. Dr. Demopulos, who has served as President, CEO, and Chairman since its inception, has a background in orthopedic surgery from Stanford University and a fellowship in microvascular surgery from Duke University. His medical and scientific expertise has been central to the company's focus on creating therapies for unmet medical needs.

Omeros' business model is vertically integrated, managing the entire drug development process from discovery to commercialization. Its revenue streams have included product sales, royalties, and R&D collaborations. A significant milestone was the 2014 FDA approval of OMIDRIA, used during cataract surgery. In 2021, Omeros sold OMIDRIA to Rayner Surgical in a transaction valued at over $1 billion, shifting its revenue source from direct sales to royalties on OMIDRIA's net sales.

The company's pipeline is focused on immunologic disorders, including complement-mediated diseases, central nervous system (CNS) disorders, and immuno-oncology. A key area is its complement franchise, which targets components of the immune system. Its lead product candidate is narsoplimab (OMS721), a monoclonal antibody that inhibits MASP-2, the key effector enzyme of the lectin pathway of the complement system. This targeted inhibition is designed to prevent inflammation and endothelial damage associated with lectin pathway overactivation, without interfering with the critical infection-fighting classical complement pathway. Narsoplimab is under review by the FDA for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), a severe and often fatal complication with no approved treatment. The FDA has assigned a target action date of December 26, 2025. The pipeline also includes OMS906 (zaltenibart), an inhibitor of MASP-3 for alternative pathway disorders like paroxysmal nocturnal hemoglobinuria (PNH), and OMS1029, a long-acting MASP-2 inhibitor.

Keywords: biopharmaceutical, complement system, narsoplimab, MASP-2 inhibitor, lectin pathway, thrombotic microangiopathy, TA-TMA, orphan drugs, immunological disorders, central nervous system disorders, OMS906, MASP-3 inhibitor, inflammation, protein therapeutics, immuno-oncology, paroxysmal nocturnal hemoglobinuria, Gregory A. Demopulos, drug development, clinical trials, FDA