Icon Bioscience Reports Successful Outcomes Of Phase 3 Study Of Ibi-10090, A Novel Sustained Release Drug Being Developed To Treat Inflammation Associated With Cataract Surgery
Detailed Results to be Presented at 2015 ASCRS-ASOA Symposium & Congress
Sunnyvale, CA (April 6, 2015) – Icon Bioscience Inc., a specialty biopharmaceutical company focused on utilizing its Verisome® drug delivery platform to develop unique intraocular eye-care therapeutics, today announced that Phase 3 data showed significantly positive outcomes for IBI-10090 compared to placebo in treating inflammation associated with cataract surgery.
The Phase 3 study of IBI-10090, completed in the fourth quarter of 2014, was a prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial involving 394 patients. The ensuing analysis of data shows IBI-10090 – with regard to both primary and secondary study endpoints – to be safe as well as highly effective.
A detailed discussion of the study results will be given April 19th at the 2015 Annual Symposium & Congress of the American Society of Cataract and Refractive Surgery (ASCRS) & American Society of Ophthalmic Administrators (ASOA). The presentation entitled Safety and Efficacy of a Novel Intracameral Dexamethasone Drug Delivery Suspension for Treating Inflammation Associated With Cataract Surgery is co-authored by Eric D. Donnenfeld, MD (Ophthalmic Consultants of Long Island), Edward J. Holland, MD (Cincinnati Eye Institute), and Wendy Murahashi, MD (Icon Bioscience). An abstract of the presentation is currently available online at here
IBI-10090 utilizes the Verisome technology 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 over 3 million cataract surgeries in the US annually and with the standard of care for associated inflammation being a comparably burdensome, protracted process of multiple daily eye drops, “IBI-10090 addresses a clear medical need in a large ophthalmic pharmaceutical space,” said David S. Tierney, MD, Icon’s President & CEO.
Dr. Tierney noted that “Icon is pursuing a 505(b)(2) regulatory approval route for IBI-10090, reflecting a strategy of reducing product development risks by applying the Company’s unique Verisome technology to significantly expand the therapeutic value of an already approved drug entity.” Dexamethasone, the active ingredient in IBI-10090, is a well-established prescription drug found in generic and branded medications. In the category of ophthalmic pharmaceuticals, Dexamethasone can be found in product offerings from Allergan (NYSE:AGN) as well as the Alcon eye-care division of Novartis AG (NYSE:NVS) and the Bausch & Lomb operations of Valeant Pharmaceuticals (NYSE:VRX).
“As IBI-10090 moves out of the pipeline toward marketing approval, Icon will realize significant growth milestones,” said Tierney. “The potential regulatory approval of IBI-10090 in the foreseeable future will strongly validate and enhance the value of our Verisome drug delivery platform while positioning the Company for growth as a commercial operation.” He concluded saying, “This is truly an exciting time for Icon.”
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.