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 https://ascrs.confex.com/ascrs/15am/webprogram/Paper18879.html
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. For additional information visit the
Icon website at www.iconbioscience.com
Copyright Business Wire 2015