A device developed by a medical team that includes Dominican ophthalmologist Juan Francisco Batlle Pichardo has reached the US Food and drug Administration (FDA) Phase One clinical trial. The device is the InnFocus MicroShunt glaucoma drainage implant. As reported, the company expects the final phase of its FDA clinical trials to begin later this year.
Batlle Pichardo worked with the University of Miami’s Bascom Palmer Eye Institute to develop the medical device.
“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 CEO. “The rate of treatment volume in the study has increased substantially giving us great confidence we will complete the final phase quickly.”
The device has already been approved for use in the European Union, as reported in El Dia.
A company press release reports that outside of the United States, the InnFocus MicroShunt is showing promising clinical results. Patients are achieving a mean post-operative Intraocular Pressure (IOP) below 14mmHg, which reduces a major risk factor for optic nerve damage and reduction of vision that can occur when IOP levels are too high. Also, over 70% of the patients have eliminated their use of eye drop medication three years after their procedure.
Glaucoma affects over 78 million people worldwide.