June 17, 2004.
Source: Refocus Group.
Refocus Group, Inc. (OTC Bulletin Board: RFCG; http://www.refocus-group.com), a medical device company engaged in the research and development of treatments for eye disorders, today announced that it has completed the enrollment and surgeries of about one-third of the subjects in the U.S. Food and Drug Administration Phase II clinical trials of the Scleral Spacing Procedure for the treatment of presbyopia.
While the results remain very preliminary, the company believes that the data continues to support its confidence in the clinical procedure. Presbyopia, which impacts virtually 100 percent of the population over age 40, is the inability of the eye to focus on near tasks such as reading a newspaper or telephone book.
The Phase II trials, which began in Feb. 2004 as previously announced, are the first opportunity for U.S. clinicians to utilize the newly developed automated scleral incision handpiece and system designed to simplify and enhance the placement of the company's scleral implants, thereby providing greater reproducibility of the procedure.
The company's scleral incision system, used to perform the Scleral Spacing Procedure, has received high marks to date from clinical investigators during the Phase II trials.
"Refocus Group's new automated scleral incision system has resulted in more accurate and precise placement of the implants," said Gene Zdenek, M.D., head of the Zdenek Eye Institute in Reseda, Calif., and a Phase II clinical investigator. "I believe that this will translate into even better outcomes than experienced in Phase I of the study."
"The scleral incision system gives us the ability to place the scleral implants at the perfect incision depth virtually every time," said Barrie Soloway, M.D., a Phase II clinical investigator who is Refocus Group's medical director as well as director of vision correction at New York Eye and Ear Infirmary in Manhattan. "The improvements that have been made in the system have resulted in greater consistency and standardization of the procedure."
The Phase II trials are being conducted as a multi-center, randomized study at five U.S. sites, with 100 subjects to receive the scleral implants and another 50 subjects designated as control. After the FDA's later review of a portion of the Phase II preliminary results, the company would expect to receive approval to expand the trial by enrolling a significant number of additional patients at up to five additional clinical sites.
About Refocus Group's Scleral Spacing Procedure.
Presbyopia is a vision disorder that affects virtually 100 percent of the population over age 40.
Glaucoma affects millions worldwide and is a leading cause of blindness.
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. 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.
End of article.
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