News
11/07/1994

<TITLE>FDA APPROVES SILICONE OIL FOR RETINAL REATTACHMENT</TITLE>
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P94-20                             Food and Drug Administration
FOR IMMEDIATE RELEASE              Sharon Snider (301) 443-3285

       
     The FDA today announced approval of silicone oil, a new
product for reattaching the retina in certain complicated cases of
retinal detachment.  The retina can become detached from within the
eye through injury or disease, including AIDS.  If untreated, this
can result in blindness.
     In clinical studies of patients with complicated retinal
detachment, the silicone oil product, Adatomed Silicone Oil, was
successful in reattaching the retina in 60 to 75 percent of
patients into whose eyes it was injected.
     "Each year, a small number of people with retinal detachment,
including many people with AIDS, go blind because standard surgical
procedures don't work," said FDA Commissioner David A. Kessler,
M.D.  "Silicone oil offers a new alternative that could save their
sight."
     The oil was approved to treat complicated retinal detachments
that cannot be corrected with standard surgery.  It is the most
effective treatment for retinal detachment related to
cytomegalovirus (CMV) retinitis, which affects many people with
AIDS.
                             -MORE-
ATTENTION:  PLEASE USE OPEN CAPTIONING FOR THE HEARING IMPAIRED.
                                       Page 2, P94-20, Silicone Oil
      The oil is designed to be used in conjunction with, or
following, other standard surgical procedures.  It is a sterile,
clear, colorless liquid that is injected into the eye and
mechanically holds the retina in place until it reattaches to the
inner surface of the eye.  It is made by Adatomed of Germany, a
division of Chiron Vision Corporation, Irvine, Calif.
     The oil is not intended to remain in the eye permanently.  The
product labelling recommends that in most cases it be removed
within a year after surgery, depending on the risk of redetachment. 
With AIDS patients, to minimize the number of surgeries these
patients often undergo, it need not be removed.
     FDA approved the product based on a review of laboratory and
clinical studies of safety and effectiveness conducted by the
manufacturer, on studies reported in the scientific literature, and
on the unanimous recommendation of its Ophthalmic Devices Panel of
the Medical Devices Advisory Committee.
     Chiron Vision studied 155  patients at 11 medical centers in
the United States.  In addition, 299 patients were studied in
Europe as part of a Silicone Oil Study Group.  The retina was
successfully reattached in 60 to 75 percent of patients treated
with the oil.  In about 80 percent of these patients,  visual
acuity either improved or stayed the same after the surgery. 
Normally, vision deteriorates in people with complicated retinal
detachment.
                             -MORE-

                                     Page 3, P94-20, Silicone Oil
     Reattachment rates in people with AIDS-related CMV retinitis 
were as high as 96 percent.  Visual acuity either improved or
stayed the same in 57 percent.
     Complications included development of cataracts, corneal
diseases and glaucoma.  All of these conditions can be treated with
medical devices, drugs or surgery. 
     Adatomed Silicone Oil is a highly purified oil, not a silicone
gel.  Unlike silicone gel which can leak from a breast implant, the
silicone oil is contained inside the eye.
     In addition, unlike implants, which are meant to be permanent,
the oil is intended to be removed from the eye once reattachment
occurs and the eye is stable, further reducing exposure.  The oil
was tested extensively, and no adverse immunologic effects were
reported.
     Approximately 18,000 to 30,000 people in the United States
have retinal detachment annually.  An estimated 10 percent of those
could be expected to benefit from silicone oil.  Several hundred
AIDS patients could also be expected to benefit from the oil each
year.
     FDA is one of the eight Public Health Service agencies in HHS.
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