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SOURCE InnFocus, Inc.
Three Year Data Showing Sustained Mean IOP Reduction of 50% with 85% of Patients Completely off Eye Drop Medications
NICE, France, June 11, 2014 /PRNewswire/ -- InnFocus, Inc., reported on a series of 43 glaucoma patients (n=34, 22 and 17 at 1, 2 and 3 years) treated with the Company's MicroShunt™ implant. The average IOP reduction from medicated baseline (23.6 mmHg) was 50%, averaging 10-12 mmHg over the 3-year time-frame. This reduction in IOP to below 14 mmHg reduces a major risk factor for optic nerve damage.
The Company, which shared its updated results at the 11th European Glaucoma Society Congress in Nice, France this week, also presented data showing 85% of patients are totally off glaucoma medication with a reduction in medication from 2.8 to 0.4 meds/patient at three years. The patients showed no long-term adverse events. None of them needed to be converted to trabeculectomy or large plate valves.
"We believe these significant results indicate the InnFocus MicroShunt™ has tremendous potential to provide a safe, effective, sustainable, easy to perform alternative for the surgical treatment of glaucoma," said Russ Trenary, InnFocus President & Chief Executive Officer.
The Company has initiated Phase I Food and Drug Administration trials at 10 centers in the U.S.
The InnFocus MicroShunt provides a quick and simple method of shunting aqueous humor from the anterior chamber to a diffuse bleb without the use of a scleral flap, using a micro-tube to control flow made from the innovative and patent-protected SIBS material. The mechanism of action for subconjunctival/Tenons drainage for the MicroShunt™ has been the accepted gold standard for several decades.
About InnFocus MicroShunt™
The InnFocus MicroShunt™ (formerly known as the "MIDI Arrow") is a glaucoma drainage implant consisting of a micro-tube about twice the size of an eyelash. It is made from a soft proprietary biomaterial that demonstrates insignificant inflammation or encapsulation in the eye. It is implanted with the inflow end in the anterior chamber at the angle, and the outflow end under the conjunctiva and Tenon's capsule. The product has been implanted alone or in combination with cataract surgery in clinical trials outside of the U.S. in patients ranging from early to late stage glaucoma.
Caution: Investigational device. Limited by Federal Law to Investigational Use.
About InnFocus, Inc.
InnFocus, Inc. is a privately-held company headquartered in Miami, Florida. The Company's scientists and engineers are global leaders in the development of highly biocompatible biomaterials and medical devices. The InnFocus MicroShunt™ was developed in collaboration with the University of Miami, Miller School of Medicine, Bascom Palmer Eye Institute, which has been ranked the number one eye hospital in the U.S. for the 10th year in a row by U.S. News & World Report.
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