InnFocus MicroShunt Glaucoma Drainage Implant Showing Promising Results in Other Studies
MIAMI, April 13, 2015 /PRNewswire/ — InnFocus Inc. reports that treatments for its U.S. Food and Drug Administration (FDA) Phase One clinical trial of the InnFocus MicroShunt® glaucoma drainage implant have now reached the required 75 patients. Upon successful review of the data from these subjects at 3 months by the Data Safety Monitoring Board and the FDA, the Company said it expects the final phase of its FDA clinical trials to begin later this year.
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"Achieving this milestone is an important step in our goal to provide a safe, effective, sustainable, and easy to perform alternative for the surgical treatment of glaucoma," said Russ Trenary, InnFocus President & CEO. "The rate of treatment volume in the study has increased substantially giving us great confidence we will complete the final phase quickly."
Outside the United States, the InnFocus MicroShunt is showing promising clinical results. Patients are achieving a mean post-operative Intraocular Pressure (IOP) below 14mmHg, which reduces a major risk factor for optic nerve damage and reduction of vision that can occur when IOP levels are too high. Also, over 70% of the patients have eliminated their use of eye drop medication at 3 years after their procedure.
"We want to enable doctors to 'think low' for early to late stage glaucoma with what we believe is a revolutionary means for reducing both IOP and glaucoma medication use," Trenary added.
Glaucoma affects over 78 million people worldwide. The disease is a serious health care problem that is not always easy to diagnose and, often is difficult to treat successfully. The InnFocus MicroShunt® addresses the largest patient segment in glaucoma.
The InnFocus MicroShunt® has been implanted alone or in combination with cataract surgery in clinical trials outside the United States. It was developed in collaboration with the University of Miami's Bascom Palmer Eye Institute, and it provides a quick and simple method of shunting aqueous humor from the anterior chamber to a diffuse bleb without the need for a scleral flap.
It uses a patented micro-shunt made from the innovative SIBS material to control flow. The mechanism of action for the MicroShunt of subconjunctival/Tenons drainage has been the accepted gold standard. The Company's revolutionary SIBS material is ultra-stable, has not degraded and possesses a 13-year proven history in drug eluting coronary stents.
CAUTION; INVESTIGATIONAL DEVICE. LIMITED TO INVESTIGATIONAL USE IN THE UNITED STATES.
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