Refocus Group Inc announced European CE Mark approval for the PresVIEW Scleral Incision System, which includes the Scleral Incision Hand Piece, Blade and Control Box. These components are key elements of Refocus Group's re-engineered PresVIEW Scleral Spacing Procedure for the surgical treatment of presbyopia, primary open angle glaucoma and ocular hypertension. The updated procedure incorporates these automated components to simplify and enhance the placement of the company's PresVIEW Scleral Implants, resulting in greater reproducibility of the procedure by clinicians. The CE Mark approval permits the commercial sale of these products in the European Union.

"Though we have achieved dramatic results in many of the various clinical and commercial procedures conducted in recent years, we believe our new automated incision system enables greater consistency of treatment results across a wider surgeon skill set," said Terry Walts, president and CEO of Refocus Group. "We expect these improvements to open up interest and adoption of the PresVIEW Scleral Spacing Procedure across a much larger universe of surgeons and patients as we prepare for commercial launch in Europe and the initiation of U.S. FDA Phase II clinical trials."

Improvements made to the Scleral Spacing Procedure since 2000 include:

* The addition of ultrasound mapping, which allows the surgeon to more accurately determine the optimum location for each implant in relation to the eye's crystalline lens in preparation for surgery.

* An automated hand piece with a snap-on disposable mechanical blade, developed to potentially create safer, more uniform and repeatable scleral "tunnels" for each implant-replacing the now obsolete hand scalpel.

* A Control Unit, which gives the clinician computerized control and monitoring during the surgical procedure for greater precision and reproducibility.

* The latest PresVIEW Scleral Implant design incorporates beveled edges and grooves for ease in placement and to permit more secure scleral anchoring.

As previously announced, Refocus Group's strategic partner, CIBA Vision, plans a commercial launch of the PresVIEW Scleral Spacing Procedure in selected European markets by the end of 2003. Refocus Group also intends to begin U.S. FDA Phase II clinical trials of the Scleral Spacing Procedure for the treatment of presbyopia in the latter part of 2003, subject to FDA approval.

Glaucoma affects millions worldwide and is a leading cause of blindness. Presbyopia impacts virtually 100 percent of the population at or after age 40. Refocus Group's PresVIEW Scleral Spacing Procedure for surgically treating presbyopia, primary open angle glaucoma and ocular hypertension utilizes four PresVIEW Scleral Implants, each about the size of a grain of rice, which are surgically placed in the four quadrants of the sclera (white of the eye). In the case of glaucoma, this restores the base-line tension in the ciliary body, allowing for improvement in the natural drainage of the eye and lowering intraocular pressure. In the case of presbyopia, it reduces the crowding of the underlying tissues surrounding the crystalline lens, allowing the muscles to once again reshape the lens and focus the eye. The uniqueness of the PresVIEW 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 treatments for presbyopia. In addition, the procedure can be performed on an outpatient basis under topical or local anesthesia.