For those who are following progress of the development of surgery to
reduce presbyopia (when the eye no longer is able to change focus and
reading glasses or bifocals are necessary), here is a press release
from one of the companies.

~~~~~~~~~~
Refocus Group (Formerly Presby) Completes First Half Of Phase II
Clinical Trial Surgeries For Presbyopia And Announces Preliminary
Results

DALLAS, Dec. 20 -- Refocus Group, Inc. , a medical device company
engaged in the research and development of treatments for eye
disorders, today reported preliminary data on surgical patients at the
important three- and six-month follow-up exam milestones and announced
the completion of the first half of its U.S. Food and Drug
Administration Phase II clinical trial surgeries for the treatment of
presbyopia.

To date, 50 of a planned total of 100 Phase II study participants have
undergone the company's Scleral Spacing Procedure (SSP) for the
surgical treatment of presbyopia (the loss of near or reading vision
impacting virtually 100 percent of the population after age 40). In
addition, 26 of a planned 50 control participants have been enrolled
for comparative monitoring. Of the 50 SSP surgical participants, 45
have now completed three- or six-month follow-up exams. Preliminary
data on these surgical patients indicates:

-- 80 percent of these surgical patients experienced sufficient
improvement to result in 20/40 or better reading vision (roughly
equivalent to Jaeger 3 or better), which is the vision generally
needed to read a phone number in a typical telephone book without
reading glasses.

-- Surgical patients have experienced an improvement in their
Snellen near  vision acuity averaging nearly 3 lines of improvement.
Near vision  acuity is the common measure of a patient's ability to
distinguish letters or words at a normal reading distance.  Lines of
improvement refer to the progressively smaller lines of print on the
near vision acuity chart.

-- 15 (one-third) of these patients experienced an improvement of 4
lines or better, with some patients experiencing up to 6 to 7 lines of
improvement in near vision acuity.

-- About 90 percent of these surgical patients answering a survey
describe the change in their reading vision as "better" or
"significantly better."

-- Importantly, there has been virtually no change in any patient's
best-corrected distance vision as a result of SSP.

-- Finally, these preliminary Phase II results were also favorable
when compared to the non-surgical control group and when compared to
the company's FDA Phase I results, which used an earlier surgical
protocol without the new automated incisional handpiece.

The company stressed that while this data remains preliminary, it
continues to support the company's belief in its presbyopia treatment
and clinical approach. The company expects to submit the clinical data
to the FDA in a Phase II study report during 2005.

"Refocus Group's clinical results, while still preliminary, suggest
that for the first time, there appears to be a mainstay surgical
alternative for treating presbyopia that does not have the inherent
compromises of other more invasive or irreversible surgical
approaches," said Barrie Soloway, M.D., Refocus Group's medical
director and director of vision correction at New York Eye and Ear
Infirmary in Manhattan.

"In order to improve near vision, other existing surgical treatments
often result in an undesired compromise of distance vision such as
glare or halos, loss of depth perception or loss of contrast
sensitivity."

"We are very pleased by the continued progress in our clinical study,"
said Terry Walts, president and CEO of Refocus Group. "Achievement of
the halfway point in our Phase II FDA surgeries with these promising
preliminary results represents a significant milestone for the
company. Based on these results to date, we would expect to receive
FDA approval in 2005 to advance to the final, or third, phase of the
clinical trial."

The company also reported that it does not currently have sufficient
cash on hand to continue its operations for the full first quarter of
2005, unless additional funds are obtained. Refocus Group has retained
a placement agent to arrange the sale of the company's Series A
Preferred Stock in a private offering to accredited investors. The
company is also separately in discussions with potential strategic
partners and investors. No assurance can be given that the company
will be able to obtain financing on acceptable terms. See the
company's most recent Form 10-QSB filing for a full discussion of the
company's financial condition. The inability of the company to obtain
additional financing would have a material adverse effect on the
company.

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 the four quadrants. Presbyopia is a vision disorder that
affects virtually 100 percent of the population over age 40, and
continues to get worse as people age. Glaucoma affects millions and is
the third leading cause of blindness for people over age 40 worldwide.
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 thus 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 company's technology is
unique in that it does not remove tissue from the eye, does not affect
the cornea and is believed to be fully reversible, unlike LASIK or any
other treatment involving the permanent removal and replacement of the
crystalline lens with an intraocular lens. Finally, unlike various
approaches to "monovision" (where only one eye is corrected for
reading vision), clinical data to-date indicates that SSP improves the
reading vision of both eyes without compromising distance vision. The
company's implant device is limited by United States federal law to
investigational use, pending approval by the Food and Drug
Administration.

About Refocus Group

Refocus Group is a Dallas- based medical device company engaged in the
research and development of treatments for eye disorders. Refocus
holds about 95 domestic and international pending applications and
issued patents, the vast majority directed to methods, devices and
systems for the treatment of presbyopia, ocular hypertension and
primary open-angle glaucoma. The company to-date has aggressively
defended its intellectual property rights.

Web site: http://www.refocus-group.com/

Report this post to a moderator

[  Post Follow-up to this message ]