InnFocus reported that the first two surgeries have been conducted in Japan in a clinical investigational study using the InnFocus MicroShunt glaucoma drainage implant.
The surgeries were performed at the Yotsuya Shirato Eye Clinic in Tokyo, Japan. InnFocus has developed a safe, effective, sustainable and easy-to-perform alternative for the surgical treatment of glaucoma, which affects over 60 million people worldwide.
"We are honored to be the first surgeons in Japan to implant the MicroShunt," said Makota Aihara, M.D., Ph.D., who is deputy chief at the Shirato Eye Clinic. "Glaucoma is a major health care issue in Japan and finding new, less invasive ways to treat the disease is a key goal for us."
The InnFocus MicroShunt, which is a glaucoma drainage implant consisting of a microtube about twice the size of an eyelash, is in Phase 1 Food and Drug Administration trials at 11 centers in the US. Patients have also been treated in France and the Dominican Republic in addition to Japan and the US. The company expects surgeries in additional European countries by the end of 2014.
The Company previously reported that a series of 43 glaucoma patients treated with the InnFocus MicroShunt have experienced a reduction in Intraocular Pressure (IOP) below 14mmHg for over two years which reduces a major risk factor for optic nerve damage and reduction of vision. The Company also reported that over 80 percent of these patients are totally off glaucoma medication.
"Introducing the InnFocus MicroShunt into Japan is an important step in the development of our company," said Russ Trenary, InnFocus CEO. "We are excited the world’s glaucoma community is learning more about what we believe is a revolutionary means for reducing IOP and treating 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.
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.