Refocus Group reports promising initial results

Dallas-Refocus Group Inc., a medical device company engaged in the research and development of treatments for eye disorders, announced promising preliminary data from the company's ongoing phase II clinical trials for the treatment of presbyopia.

"My first group of seven patients to reach the 3-month exam milestone experienced an average of three lines of improvement in near vision, after undergoing Refocus Group's scleral spacing procedure," said Gene Zdenek, MD, head of the Zdenek Eye Institute in Reseda, CA, and one of Refocus Group's phase II clinical investigators.

Refocus Group noted that the data also indicate that all patients in this initial group now have vision sufficient for reading newspaper-size print without glasses.

"These results, while preliminary, continue to support our belief that our scleral implant and scleral spacing procedure is effective as a surgical treatment option for presbyopia, without the inherent compromises or irreversibility of alternative approaches," said Terry Walts, president and chief executive officer of Refocus Group.

Refocus Group remains on track to complete the enrollment of its remaining phase II patients by the end of the year, subject to adequate financing.

Subject to FDA review and approval, the company would expect to receive FDA approval to advance to the final, third phase of FDA clinical trials in early 2005.