SUNNYVALE, Calif., Apr 20, 2015 (BUSINESS WIRE) -- Icon Bioscience Inc., a specialty biopharmaceutical company focused on utilizing its patented and proprietary Verisome® extended-release drug delivery platform to develop unique intraocular eye-care therapeutics, today reported data from its pivotal Phase 3 clinical trial for IBI-10090. The results of the trial showed that IBI-10090 is highly effective in treating inflammation post cataract surgery.
An estimated 4 million cataract surgeries are performed in the U.S. annually. Inflammation is common following such surgery and can lead to serious complications, if left untreated. Post-operative care typically involves the use of an ophthalmic anti-inflammatory medication applied topically several times daily over an extended period of time. .
IBI-10090 employs Icon's Verisome® technology to dispense an extended-release, biodegradable formulation of the anti-inflammatory agent dexamethasone into the anterior chamber of the eye through a single administration immediately following cataract surgery. "This is a novel therapeutic designed to improve the management of post surgery inflammation," noted David S. Tierney, MD, Icon's President & CEO. "IBI-10090 has been developed to increase efficacy by placing the drug at the site of action and to help patients, in a largely elderly population, avoid noncompliance and dosing errors associated with the comparatively burdensome process of multiple, self-administered, daily eye drops."
A discussion of the Phase 3 results was presentedon April 19th at the 2015 Annual ASCRS-ASOA Symposium & Congress by Eric D. Donnenfeld, MD, Clinical Professor of Ophthalmology, New York University and Trustee, Dartmouth Medical School for the study investigators. Commenting on today's press release, Dr. Donnenfeld noted, "In this Phase 3 trial, IBI-10090 showed unprecedented efficacy in reducing inflammation associated with cataract surgery, with a safety profile similar to that of placebo. IBI-10090 could prove to be an important new therapy as an alternative to frequent corticosteroid drop instillationin post cataract surgical care."
Vernon Wong, MD, Icon's Chairman and founder, said "The success we have achieved to date with the development of IBI-10090 reflects the dedication and hard work of the entire team at Icon, and we are encouraged and excited about pursuing the next steps in bringing our first Verisome® based product out of the pipeline and into the marketplace."
IBI-10090 Phase 3 Clinical Trial Highlights
The Phase 3 study of IBI-10090 was a prospective, randomized, double-masked, placebo-controlled, multicenter clinical trial involving 394 patients consisting of both men and women aged 40 years and older, undergoing unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation. Three treatment arms included placebo and IBI-10090 at 342 µg or 517 µg placed into the anterior chamber of the eye at the conclusion of cataract surgery. Patients were followed for 90 days postoperatively. The primary endpoint in the clinical trial was the percentage of patients achieving anterior chamber cell (ACC) clearing at day 8, i.e., ACC=0. Secondary outcome measures included anterior chamber flare (ACF) and anterior chamber cell + flare (ACCF) clearing in the study eye. Ocular and non-ocular adverse events were assessed.
In both of the clinical trial's drug treatment arms, the percentage of patients with an ACC=0 grade at day 8 was statistically significant compared to placebo. Specifically, the percentage of patients with ACC clearing at day 8 was 63.1%, and 66.0% in the 342 µg and 517 µg treatment groups, respectively, (P< 0.001) compared to 25.0% in the placebo group.
With regard to secondary endpoints, the percentage of patients with ACF clearing at day 8 was 92.4%, and 89.1%, respectively, in the 342 µg and 517 µg treatment groups (P< 0.001) compared to 63.8% in the placebo group. The percentage of patients with ACCF clearing at day 8 was 63.1% and 67.3% in the 342 µg and 517 µg treatment groups, respectively, (P< 0.001) compared to 33.8% in the placebo group. Additionally, no ocular serious adverse events were reported up to day 90 and adverse events among the three groups were similar.
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® extended-releasedrug 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 diabetic macular edema, glaucoma, age-related macular degeneration and cataract surgery. For additional information visit the Icon website at www.iconbioscience.com.
SOURCE: Icon Bioscience Inc.
Icon Bioscience, Inc.
David S. Tierney, MD, President & CEO
Hector Casab, VP Finance
Wendy Yee Murahashi, MD, VP, Clinical Development