InnFocus MicroShunt® 3-Year Results of a Long Term Clinical Trial Show Long Lasting IOP Reduction
MIAMI, Jan. 27, 2016 /PRNewswire/ -- Glaucoma patients treated in a prospective clinical trial with the InnFocus MicroShunt® Drainage System and followed for over three years experienced significant reduction in both Intraocular Pressure (IOP) and use of glaucoma medication. The results of the study were recently published in the peer reviewed Journal of Glaucoma*
The patients studied had an average pre-surgical fully medicated intraocular pressure of 23.8 mm Hg. Three years after being treated with the InnFocus MicroShunt® System the average IOP was reduced 55% to 10.7 mm Hg. Over 80% of the 22 patients achieved an IOP under 14 mm Hg. Sixty-four percent of patients did not require any glaucoma medication at the third year of the study.
"These results show not only the potential effectiveness but the possibility for sustainability of low IOP with the InnFocus procedure," said Juan F. Batlle, MD the principal surgeon and lead author of the article.
The company will be seeking FDA approval for the InnFocus MicroShunt System, as the first minimally invasive stand-alone procedure for mild, moderate, and severe stage open angle glaucoma, which lowers and sustains IOP under 15 mm Hg, with the potential to eliminate eye drop medications in most patients. Unlike many MIGS (micro-invasive glaucoma surgery) technologies, the InnFocus MicroShunt does not require simultaneous removal of the cataract.
The prospective study of the InnFocus MicroShunt System, used intraoperatively with mitomycin C, implanted both alone or in combination with phacoemulsification, was conducted by Dr. Batlle's team at Centro Laser in Santo Domingo, Dominican Republic. The study results indicate that the InnFocus procedure achieved IOP control up to 3 years of follow-up with only mild transient adverse events (e.g, 2 cases of IOP < 6 mm Hg after day 1 and 2 cases of choroidal effusion), all resolving without surgical intervention within 3 months of surgery. Importantly, there were no leaks, infections, migrations, erosions, persistent corneal edema, chronic hypotony or serious long-term adverse events.
Over 250 patients have now been treated in clinical trials with the InnFocus MicroShunt in Canada, France, Japan, the Netherlands, Spain, Switzerland, the Dominican Republic and the US.
The final phase of the FDA randomized clinical study comparing the InnFocus MicroShunt System to trabeculectomy is underway.
The InnFocus MicroShunt® drainage device is made from SIBS, an innovative, highly biocompatible biomaterial 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.
For more information visit www.innfocusinc.com
*Batlle, Juan F. MD; Fantes, Francisco MD; Riss, Isabelle MD, et al. Three-Year Follow-up of a Novel Aqueous Humor MicroShunt. Journal of Glaucoma: Published on line January 13, 2016, doi: 10.1097/IJG.0000000000000368
CAUTION: INVESTIGATIONAL DEVICE. LIMITED TO INVESTIGATIONAL USE IN THE UNITED STATES.