SAN FRANCISCO, Feb. 9, 2015 /PRNewswire/ — InnFocus Inc. Chief Executive Officer Russ Trenary reports on a series of 82 patients that have been implanted with the InnFocus MicroShunt® outside the United States. The patients experienced a mean reduction in Intraocular Pressure (IOP) from a pre-operative value of 23 mmHg, while still on eye drop medications, to a post-operative value of below 14 mmHg, which reduces a major risk factor for optic nerve damage and reduction of vision.
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The latest results were shared at the fourth annual New Horizons Forum, which highlights new therapies and diagnostics for glaucoma patients. The Glaucoma Research Foundation holds the event in San Francisco prior to its annual Glaucoma 360 meeting.
"We are increasingly excited about the results being shown internationally with the InnFocus MicroShunt®," said Trenary. "In addition to lowering IOP, we're seeing an 84% reduction in glaucoma medication, with over 70% of the patients entirely off eye drops after three years."
Patients in France, Japan, Spain and the Dominican Republic are included in the data Trenary presented. In addition, the device is in Phase 1 FDA trials at 12 centers in the United States. The company says it expects to begin the final FDA trial phase later in 2015.
"Since the data show a significant and stable drop in Intraocular Pressure (IOP), I believe that many surgeons will decide to intervene and use the MicroShunt earlier in their treatment of glaucoma," said Professor Dr. Isabelle Riss of Bordeaux, France, who has treated the largest number of patients in the series.
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. The device 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.
It uses a patented micro-shunt made from the innovative SIBS material to control flow. The mechanism of action of subconjunctival/Tenons drainage has been the accepted gold standard.
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