IOP Levels Stable and Below 14mmHG after one year in another series
MIAMI, Sept. 22, 2014 /PRNewswire/ — InnFocus, Inc. reported today that it shared one year results from 34 patients treated, utilizing the current surgical technique for the InnFocus MicroShunt ™ glaucoma drainage implant, at the European Society of Cataract and Refractive Surgery (ESCRS) meeting in London.
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Professor Dr. Isabelle Riss of Bordeaux, France made the presentation at the ESCRS, which included patients treated in the Dominican Republic by Dr. Juan Batlle and her patients treated in France. Professor Riss first implanted the InnFocus MicroShunt™ utilizing the current surgical techniques in 2011. In the two groups represented here Professor Riss modified the concentration of MMC utilized during the procedure from 0.4mg / ml to 0.2 mg.
"A significant and stable drop in intraocular pressure (IOP) was noted," said Professor Riss. "IOP for the two groups averaged between 11 and 13 mmHg at one year, which represented a 45 to 53% reduction."
The Company reported these results are similar to another series of patients who have been followed for up to three years, which it says demonstrates multiple doctors at multiple sites can achieve the same excellent results.
"The InnFocus MicroShunt™ is a new and less invasive way to treat glaucoma," added Professor Riss. "The fact that 73% in the first group and 87% in the second group of patients we followed for a year are totally off glaucoma medication is a key advantage."
Her presentation also reported no long-term sight threatening adverse events using the InnFocus MicroShunt™.
"The InnFocus MicroShunt has potential to reach a very large number of glaucoma patients. We don't need to rely upon combining our device implantation with cataract removal to achieve these impressive levels of IOP reduction," said Russ Trenary, InnFocus President & Chief Executive Officer.
InnFocus is working to develop a safe, effective, sustainable and easy-to-perform alternative for the surgical treatment of glaucoma, which affects over 75 million people worldwide.
The InnFocus MicroShunt™ is a glaucoma drainage implant consisting of a microtube about twice the size of an eyelash. It is currently in Phase 1 Food and Drug Administration trials at 11 centers in the United States. Patients have also been treated in several locations in France, the Dominican Republic, and Japan in addition to the U.S. The Company says surgeries in additional European countries are expected to be performed by the end of 2014. The Company has now treated over 46 patients with its current generation and expects to have treated approximately 150 by the end of 2014.
The InnFocus MicroShunt™ has been implanted alone, or in combination with cataract surgery, in clinical trials outside of the United States in patients ranging from early to late stage glaucoma.
The InnFocus MicroShunt™, which was developed in collaboration with the University of Miami's Bascom Palmer Eye Institute, 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 subconjunctival/Tenons drainage for the MicroShunt has been the accepted gold standard for decades.
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