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InnFocus reaches 75-patient treatment milestone
Treatments for InnFocus Inc.’s FDA phase I clinical trial of the InnFocus MicroShunt glaucoma drainage implant have now reached the required 75 patients.
Treatments for InnFocus Inc.’s FDA phase I clinical trial of the InnFocus MicroShunt glaucoma drainage implant have now reached the required 75 patients.
Upon successful review of the data from these subjects at 3 months by the Data Safety Monitoring Board and the FDA, the company said it expects the final phase of its FDA clinical trials to begin later this year.
"Achieving this milestone is an important step in our goal to provide a safe, effective, sustainable, and easy to perform alternative for the surgical treatment of glaucoma," said Russ Trenary, InnFocus president and chief executive officer. "The rate of treatment volume in the study has increased substantially giving us great confidence we will complete the final phase quickly."
Outside the United States, the device is showing promising clinical results. Patients are achieving a mean postoperative IOP below 14 mm Hg. Also, more than 70% of the patients have eliminated their use of eye drop medication at 3 years after their procedure.
"We want to enable doctors to 'think low' for early-to-late-stage glaucoma with what we believe is a revolutionary means for reducing both IOP and glaucoma medication use," Trenary added.
The device has been implanted alone or in combination with cataract surgery in clinical trials outside the United States. It was developed in collaboration with the University of Miami's Bascom Palmer Eye Institute, and it provides a quick and simple method of shunting aqueous humor from the anterior chamber to a diffuse bleb without the need for a scleral flap.
In other news, InnFocus Director Randy Lindholm has been named Chairman of the Board. Lindholm was previously chairman of the board and chief executive officer (CEO) of Vidamed, until it was acquired by Medtronic.
The company also announced Tim Willis, previous president and CEO of TearScience, has joined the board of directors, and will head up the Committee for External Financing.
Founder Leonard Pinchuk remains chairman emeritus and will continue to lead the company in product development.
