FDA Approves InnFocus Glaucoma Study Expansion
MIAMI, Nov. 10, 2015 /PRNewswire/ -- InnFocus Inc. announces it has received approval from the U.S. Food and Drug Administration (FDA) to expand to the pivotal final phase of its randomized clinical study comparing its InnFocus Microshunt® Glaucoma Drainage System to trabeculectomy. The Company is developing the InnFocus MicroShunt® system to treat early, moderate and late stage primary open angle glaucoma (POAG).
"As Enrollment for the final phase begins at sites in the U.S. and Europe, and with our recent Series C funding of $32.8 million, the Company is poised to become the clear leader in treating all stages of primary open angle glaucoma," said Russ Trenary, InnFocus CEO.
InnFocus had previously met the treatment totals required for Phase I and the review of safety data by its Data Safety Monitoring Board and FDA supported the move to the final phase. Completion of the Phase 1 FDA study included over 100 cases performed in the United States. An additional 412 patients are expected to be treated in the final phase of the clinical study.
Over 250 patients have now been treated with the InnFocus MicroShunt® device in the U.S., Canada, France, Japan, the Netherlands, Spain, Switzerland and the Dominican Republic. Patients outside the U.S. have experienced a mean reduction in Intraocular Pressure (IOP) from approximately 24 mm Hg on full medication to below 15 mm Hg; the majority of those patients remain off glaucoma medication.
These results outside the United States include patients treated on a stand-alone basis as well as in conjunction with a cataract procedure. IOP levels below 15 mm Hg are well known to reduce a major risk factor for optic nerve damage and vision loss which can occur when IOP is too high. Glaucoma affects over 78 million people worldwide.
"Our experience in Europe indicates that the InnFocus MicroShunt® System has the potential of being a revolutionary product for early intervention in the treatment of glaucoma," said Professor Isabelle Riss of Bordeaux, France. "We have noted a significant and stable drop in IOP and a large reduction in the need for glaucoma medications."
Professor Riss has treated more glaucoma patients with the InnFocus MicroShunt® device than any surgeon in the world.
The InnFocus MicroShunt® device is made from SIBS, an innovative, highly biocompatible material that has been implanted in the body for over 15 years. The InnFocus MicroShunt® system 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 that has been used in trabeculectomy for approximately 50 years.
CAUTION; INVESTIGATIONAL DEVICE. LIMITED TO INVESTIGATIONAL USE IN THE UNITED STATES.
For more information about InnFocus visit: www.innfocusinc.com