MIAMI, July 13, 2015 /PRNewswire/ -- InnFocus, Inc. reports that the first 3 surgeries in the Netherlands to treat glaucoma using the InnFocus MicroShunt® glaucoma drainage implant have been conducted. The InnFocus MicroShunt® is in studies to prove it is a safe, effective, sustainable, and easy-to-perform alternative for the surgical treatment for early stage to late stage glaucoma patients, which affects over 75 million people worldwide.
"The surgeries went very well and the patients are showing good results," said Dr. Henny Beckers from the University Eye Clinic Maastricht. "The surgery has the promise to be a better, faster and safer alternative to trabeculectomy or tube surgery, which could encourage surgeons to perform this procedure, earlier thus allowing patients to get off some or all of their medications quicker. We believe this technology holds great promise in the battle against glaucoma."
Patients have now been treated with the InnFocus MicroShunt® in France, Japan, Spain, Switzerland, and the Dominican Republic. Over 200 glaucoma patients have now been treated worldwide. Enrollment in Phase 1 Food and Drug Administration (FDA) trials has concluded at 13 centers in the United States. The Company expects the final clinical trial phase to begin subsequent to FDA review of the Phase I data.
The Company recently reported results for up to three years on 82 glaucoma patients treated outside the U.S. They have experienced a mean reduction in Intraocular Pressure (IOP) to below 15 mmHg, which reduces a major risk factor for optic nerve damage and reduction of vision that can occur when IOP levels are too high.
"We want to enable doctors to 'think low' for early to late stage patients with what we believe is a revolutionary means for simultaneously reducing IOP and glaucoma medication use," said Russ Trenary, InnFocus President and CEO.
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. It 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 for the MicroShunt of subconjunctival/Tenons drainage has been the accepted gold standard.
CAUTION: INVESTIGATIONAL DEVICE. LIMITED TO INVESTIGATIONAL USE IN THE UNITED STATES.
SOURCE InnFocus, Inc.