MBI moves forward with Optison

Contrast agent developer Molecular Biosystems has completed phase II studies for its myocardial perfusion agent, Optison, and has submitted its results to the Food and Drug Administration. The trials consisted of six studies with 376 participants experiencing known or suspected coronary artery disease, and showed that Optison Myocardial Contrast Echocardiography (MCE) tests were comparable to the standard clinical tests, either SPECT or coronary angiography, according to San Diego-based MBI. MBI now plans to proceed to phase III clinical trials for the agent.

Meanwhile, sales of Optison continue outside the U.S. Optison was cleared for sale in Europe in 1998 (SCAN 5/27/98), and is sold there by MBI’s marketing partner, St. Louis-based Mallinckrodt. Earlier this year, MBI signed a licensing agreement with Chugai Pharmaceuticals for marketing of the agent in Japan, South Korea, and Taiwan (SCAN 6/9/99).