BUSINESS WIRE
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