July 21, 2004.
Source: Refocus Group, Inc.
First Group of Patients Experienced an Average of Three Lines of Improvement in Near Vision.
Refocus Group, Inc. (OTC Bulletin Board: RFCG - News; http://www.refocus-group.com ), a medical device company engaged in the research and development of treatments for eye disorders, today announced promising preliminary data from the company's ongoing U.S. Food and Drug Administration Phase II clinical trials for the treatment of presbyopia.
"My first group of seven patients to reach the three-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, M.D., head of the Zdenek Eye Institute in Reseda, Calif., and one of Refocus Group's Phase II clinical investigators.
Refocus Group noted that the data also indicates that all patients in this initial group now have reading vision sufficient to read newspaper-size print without glasses. Further, in a survey completed by an early small group of the clinical trial patients, all responders indicated that they would recommend the Scleral Spacing Procedure to a friend. This preliminary data on a small group of the earliest patients has not yet been provided to the FDA, but will be included in the Phase II study report to be submitted later to the FDA for review and confirmation.
"I am very pleased with the outcomes my patients have experienced with the Scleral Spacing Procedure," added Dr. Zdenek. "Not only are all of my patients experiencing an improvement in near vision after the procedure, there were no complications and I am very pleased by the standardization of the procedure that is provided by Refocus Group's automated scleral incision system. I look forward to continued success as we proceed to the later stages of the FDA clinical trial process."
"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 CEO 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.
About Refocus Group's Scleral Spacing Procedure
Refocus Group's Scleral Spacing Procedure for surgically treating presbyopia, primary open-angle glaucoma and ocular hypertension utilizes four scleral implants, each about the size of a small grain of rice, which are surgically implanted just under the surface of the sclera (white of eye) in four quadrants. Presbyopia is a vision disorder that affects virtually 100 percent of the population over age 40, while glaucoma affects millions worldwide and is a leading cause of blindness. The surgical procedure is the same for presbyopia, glaucoma and/or ocular hypertension. For these latter two conditions, the company believes that the procedure helps restore the natural base-line tension in the ciliary body, allowing for improvement in the natural drainage of the eye and the lowering of intraocular pressure. In the case of presbyopia, the company believes that the procedure helps reduce the crowding of the underlying tissues surrounding the crystalline lens, allowing the muscles to once again naturally reshape the lens and accommodate (focus) the eye. The uniqueness of the company's technology is that it does not remove tissue from the eye, does not affect the cornea and is believed to be fully reversible--unlike LASIK or treatments involving the permanent removal and replacement of the crystalline lens with an intraocular lens. The procedure can be performed on an outpatient basis under topical or local anesthesia.
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