The FDA approval to expand to the final phase of the clinical trial was based on Refocus Group’s submission of preliminary data from phase II surgeries through mid-July 2005.
“We are now advancing toward the final stages of the clinical trial process of our surgical treatment for presbyopia,” said Terry Walts, president and CEO of Refocus Group. “We remain pleased with our clinical results to date, which continue to support our belief in the Scleral Spacing Procedure as a no-compromise mainstay surgical solution for the reduction or elimination of the need for reading glasses for close-up vision for many people after age 40.”