Final phase for FDA study on InnFocus MicroShunt® glaucoma drainage system has begun
MIAMI, Dec. 22, 2015 /PRNewswire/ — InnFocus, Inc. reports it has closed its Series C financing, which raised additional monies to total $33.9 million. The Company is developing the InnFocus MicroShunt® (IMS) glaucoma drainage system to treat early, moderate, and late stage primary open angle glaucoma (POAG). The final phase of its FDA clinical trials will begin in January, 2016.
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The InnFocus MicroShunt® FDA clinical trial is the only company sponsored prospective randomized study that compares a device to the trabeculectomy procedure, which has been the "gold standard" for treating glaucoma for approximately 50 years. Patients with mild, moderate, and severe glaucoma are included in the study.
Completion of Phase I included over 100 cases performed in the US. Over 250 patients have now been treated with the InnFocus MicroShunt® device in Canada, France, Japan, the Netherlands, Spain, Switzerland, the Dominican Republic, and the US.
The Company has reported prospective results on mild, moderate, and severe glaucoma patients treated outside the U.S. with up to three years of follow up. Patients have experienced a mean reduction in Intraocular Pressure (IOP) from approximately 24 mm Hg on full medication to below 15 mm Hg, with over 70% of patients completely off glaucoma medication 3 years after their surgery. Pressures below 15 mm Hg reduce a major risk factor for optic nerve damage and subsequent vision loss, which can occur when IOP is too high.
The InnFocus MicroShunt® was developed in collaboration with the University of Miami's Miller School of Medicine, Bascom Palmer Eye Institute. It provides a quick minimally invasive procedure for shunting aqueous humor from the anterior chamber to the same "gold standard" drainage path used in trabeculectomy. The device is made from SIBS, an innovative highly biocompatible material that has been implanted in the body for over 15 years.
The InnFocus MicroShunt® was designed to shunt aqueous humor without the need to cut scleral tissue, control suture tension, or utilize patch grafts. It has been implanted alone or in combination with cataract surgery in prospective studies outside the US.
For more information on InnFocus, visit its website (www.innfocusinc.com)
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