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 reported that IBI-10090, the Company’s lead pipeline product, is in a pivotal Phase 3 study as a sustained-release therapy for inflammation associated with cataract surgery.
A cataract, or clouding of the eye lens, generally afflicts people over the age of 60 and, according to the National Eye Institute, more than 50% of all Americans will either have a cataract or have had cataract surgery by age 80. In the US alone, an estimated 3 million cataract surgeries are performed annually. Post-operative care typically involves the use of an ophthalmic anti-inflammatory medication applied topically several times a day.
IBI-10090 employs Icon’s Verisome drug delivery platform to dispense a long-acting, biodegradable formulation of the anti-inflammatory agent dexamethasone into the anterior chamber of the eye through a single injection administered immediately following surgery. IBI-10090 has been specifically designed to provide a controlled release of the active agent for approximately three weeks, thus addressing an important market need of offering post-operative cataract patients an alternative to the significantly more cumbersome, and potentially less compliant regimen of multiple daily eye drops applied over an extended period of time.
In a previous Phase 2/3 study involving over 170 patients and three dosing strengths, IBI-10090 was found to be safe and efficacious. The primary endpoint in that study was the proportion of patients achieving anterior chamber cell (ACC) clearing at day 8, i.e., ACC=0. The percent of patients with an ACC=0 grade at day 8 in this earlier study was found to be significant for all three dosing levels of IBI-10090. According to some industry observers, the Phase 2/3 study results for IBI-10090 showed favorable efficacy to commercially available topical treatments.
The current randomized, double blind, and placebo-controlled Phase 3 study is expected to enroll 390 patients across 28 centers in the US. This dose ranging study employs the two lower doses used in the prior Phase 2/3 study. The primary endpoint is, as before, the percent of patients with anterior chamber cell clearing at day 8. Patient enrollment in the Phase 3 study began in December 2013 with a goal of competing the study later this year. More than 50% of patients have already been enrolled.
Commenting on today’s announcement, Vernon Wong MD, Icon’s Chairman & founder, said, “The timing and outcome of any clinical study can never be guaranteed; however, we are highly encouraged by prior study results and the speed at which IBI-10090 advanced into Phase 3. Thus, we are optimistic about the prospects of filing for approval in 2015.” He further noted, “Icon is clearly moving forward though an exciting growth phase in which each step closer to commercializing our product pipeline is also a step further in enhancing the asset value of our Verisome drug-delivery technology.”
David S. Tierney MD, Icon’s President & CEO added, “The ongoing progression of IBI-10090 toward approval increasingly validates our strategy of pursuing a 505(b)(2) regulatory route to reduce product development risks by applying the Verisome technology to significantly expand the therapeutic value of an already approved drug entity such as dexamethasone.”
Dexamethasone, the active ingredient in IBI-10090, is a well-established prescription drug available in a variety of 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).
Tierney concluded, “The future appears bright for Icon Bioscience, both in terms of our own robust product pipeline plus opportunities to selectively partner with companies looking at the potential utility of our Verisome technology as applied to new chemical entities or as part of a life cycle management strategy for in-market products.”
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