June 30, 2014 08:47 AM Eastern Daylight Time
SUNNYVALE, Calif.--(BUSINESS WIRE)--Icon Bioscience, Inc., a specialty biopharmaceutical company focused on utilizing its Verisome® drug-delivery platform to develop unique intraocular eye-care therapeutics, today announced the completion of patient enrollment in its pivotal phase 3 study of IBI-10090, approximately four months ahead of projected timelines.
IBI-10090, which employs the Verisome technology, is Icon's lead pipeline product. It has been designed to provide a controlled, sustained-release formulation of the anti-inflammatory agent dexamethasone into the anterior chamber of the eye through a single injection administered immediately following cataract surgery.
With some three million cataract surgeries performed annually in the US alone, IBI-10090 addresses a potentially large market. Moreover, the current standard of care for inflammation associated with cataract surgery involves a comparatively burdensome process of patient administered eye drops applied topically several times daily over an extended time period.
Commenting on today's announcement, Wendy Yee Murahashi, MD, Icon's VP, Clinical Development, said, "Enrollment in the randomized, double blind, and placebo-controlled Phase 3 study of IBI-10090 began in December 2013 with a goal of enrolling 390 patients. The study achieved that enrollment goal well ahead of time due to the dedication and hard work of everyone at Icon as well as an outstanding team of investigators and study coordinators."
David S. Tierney, MD, Icon's President & CEO added, "IBI-10090 has, in a previous phase 2 study, demonstrated a highly favorable efficacy and safety profile. Now, with the phase 3 study gaining substantial forward momentum, we are greatly encouraged about the nearer term prospects of transforming this promising pipeline product into a viable and valuable new ophthalmic drug. I join Wendy in applauding all the remarkably talented people engaged in the phase 3 study of IBI-10090."
About Icon Bioscience and Verisome®
Icon Bioscience, Inc. is a privately held specialty biopharmaceutical company focused on the development and commercialization of unique ophthalmic pharmaceuticals based on its patented and proprietary Verisome® drug delivery technology. The technology encompasses a broad number of related, but distinct drug delivery systems capable of incorporating an extensive range of active agents, including small molecules, proteins and monoclonal antibodies. Moreover, this drug delivery platform is a highly advanced, yet elegantly formulated system for controlling the release of medication within the eye for up to a year through the administration of a single injection. The technology's exceptional versatility can support products individually formulated to meet the particular clinical requirements of a given active agent targeting a specific ophthalmic disease. Icon is actively developing a broad portfolio of specialty pharmaceuticals targeting several ophthalmic indications, including macular edema, glaucoma, age-related macular degeneration and cataract surgery. For additional information visit the Icon website at www.iconbioscience.com.
Icon Bioscience, Inc.
David S. Tierney, MD, President & CEO
Hector Casab, VP Finance
Wendy Yee Murahashi, MD, VP, Clinical Development