ANSWERS
09/19/1995

<TITLE> FDA EXPECTED TO APPROVE EYE LASER FOR NEARSIGHTEDNESS
</TITLE>
<PRE>

T95-49                                             Sharon Snider
Sept. 19, 1995                                     (301) 443-3285

      FDA EXPECTED TO APPROVE EYE LASER FOR NEARSIGHTEDNESS

     The Food and Drug Administration today indicated its readiness
to approve the first ophthalmic laser to correct mild to moderate
nearsightedness in a procedure called photorefractive keratectomy
(PRK).  The laser is designed to correct nearsightedness in some
people who normally use glasses or contact lenses to improve
distance vision.  
     The following can be used to answer questions.  
     FDA expects to approve the product--the SVS Apex Excimer Laser
System made by Summit Technology, Waltham, Mass.--pending certain
design changes in the laser and completion by the firm and review
by FDA of a patient brochure and a training program and guidelines
for physicians.  The company has also agreed to conduct post-
marketing studies on the long-term safety of the device.
     FDA's decision to move forward toward approval was based on a
review of clinical, engineering and software data submitted by the
manufacturer and on the recommendation of the Ophthalmic Devices
Panel of FDA's Medical Devices Advisory Committee which met Oct.
20, 1994, to review the marketing application.
                             -More-
                                   Page 2, T95-49, Eye Laser
     The manufacturer studied about 1,400 healthy eyes on which
laser surgery was performed.  Most of the patients studied could be
corrected to 20/20 vision or better with glasses or contact lenses. 
Surgery was performed with a 5 mm ablation zone on more than l,000
eyes, and with a 6 mm ablation zone on 398 eyes.  FDA believes the
6 mm ablation zone shows the most promise for reducing potential
side effects.
      In the studies, surgeons used an excimer laser programmed to
deliver bursts of ultraviolet light to vaporize precisely targeted
corneal cells and re-sculpt the corneal curvature.  In order to
perform the procedure, the corneal surface was removed.  The effect
was to flatten the cornea.  The PRK procedure took less than three
minutes and was done under local anesthesia.  Initial time for the
corneal surface to heal after surgery was three days; vision
stabilization took approximately three months. FDA plans to require
additional studies after marketing to confirm that vision remains
stable over a long period of time. 
     Approximately 90 percent of the 398 eyes were corrected to
within one diopter (a unit of measure of spectacle or contact lens
power) of the target refraction.  In 95 percent of eyes, vision
without glasses or contact lenses was corrected to 20/40 or better. 
In 65 percent of eyes it was corrected to 20/20 or better.  Results
were best in younger patients with mild to moderate
nearsightedness.
                             -More-                                          Page 3, T95-49, Eye Laser
     Some 63 percent of patients treated experienced mild corneal
haze following surgery, and 10 percent experienced glare and halos
around lights.  These conditions diminished or disappeared in most
patients in six months.  Best corrected vision was slightly worse
after surgery in about 5 percent of patients, significantly worse
in less than 1 percent.  About 5 percent of patients continued to
need glasses all the time for distance, and up to 15 percent needed
glasses occasionally, such as when driving.
     PRK  should not be performed on people with uncontrolled
vascular disease, auto-immune disease or certain eye diseases, or
on pregnant women.  People who previously have had radial
keratotomy (RK) to correct nearsightedness should approach PRK with
caution.  In the studies, patients who previously had RK
experienced a greater loss of visual acuity from PRK than those who
did not.
     The laser has not been shown to be safe and effective for
severe nearsightedness, farsightedness or astigmatism.  People who
currently require glasses to read will continue to need them after
PRK.  As people age, they may need glasses to read even though they
have had PRK.  Also, long term risks of PRK to the cornea beyond
four years have not been studied. 
     An individual's choice of laser surgery to correct
nearsightedness should be made only after careful consideration of
alternative means of correction and the potential risks of this 
                             -More-                                        Page 4, T95-49, Eye Laser
surgery.  The individual's focusing power must be stable for at
least one year before surgery.  This surgery is performed on
healthy eyes and cannot be reversed.  The alternative choices to
correct nearsightedness include glasses, contact lenses and RK.  
     Excimer lasers by law are restricted devices.  As such, their
sale requires a prescription and their use is restricted to
physicians trained in laser refractive surgery and in the
calibration and operation of the laser.
                              #### 
   
</PRE>