TThe final phase of the FDA randomized clinical study comparing the InnFocus MicroShunt® Glaucoma Drainage System to trabeculectomy is underway in 29 centers in the United States and Europe. It is the world's only randomized trial against trabculectomy, the gold standard for lowering IOP.
In clinical trials outside the United States, at 3 years, patients who have the InnFocus MicroShunt® implanted have achieved a mean post-operative Intraocular Pressure (IOP) below 15mm Hg, which ophthalmologists believe helps halt the progression of vision loss in glaucoma patients. This represents a reduction of 50% in IOP after 3 years of follow-up. Also, over 60% of the patients have eliminated their use of eye drop medication at 3 years after their procedure. Therefore, the effect appears to be uniquely durable.
For the latest presentation about InnFocus, Inc., a wholly owned subsidiary of Santen, Inc., here is a presentation CEO Russ Trenary made at the Glaucoma 360 New Horizons Forum in San Francisco on February 3, 2017.