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<TYPE>424B1
<SEQUENCE>1
<DESCRIPTION>FINAL PROSPECTUS DATED 08/12/1999
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Expand our existing product portfolio
We intend to develop additional products to treat a broad range of vision
disorders based on our Intacs technology. For example, we are currently
conducting a U.S. Phase III trial for a product to treat myopia in both higher
ranges (-3.1 to -4.5 diopters) and lower ranges (-0.75 to -1.0 diopter). In
addition, we have recently initiated a second feasibility trial outside the
United States for our initial hyperopia product based on the results we
achieved in an earlier trial. We have also successfully treated a small number
of patients with pure astigmatism and are in the early stages of development
with a product designed to treat myopia concurrent with astigmatism greater
than +1.0 diopter. We have designed these products to retain the benefits of
our Intacs technology including maintaining the integrity of the central
optical zone and the option of removability.
In November 1996, KeraVision initiated an expanded
Phase II myopia trial involving 59 patient eyes to evaluate moderate myopia (-
3.5 to -5.0 diopters). In January 1998, KeraVision received FDA approval to
expand the Phase III trial to evaluate three additional thicknesses (0.21,
0.40, and 0.45 mm). This approval permitted KeraVision to implant Intacs
corneal ring segments into one eye of each of
26
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120 patients (40 patient eyes for each thickness), but required KeraVision to
obtain additional approval from the FDA before implanting the second eye in
those patients or enrolling any additional patients. In 82 of the enrolled 118
patients, KeraVision inadvertently implanted Intacs corneal ring segments into
the patients' second eye prior to obtaining the required approval. On July 8,
1999, KeraVision reported these unauthorized implantations in the patients'
second eye to the FDA in a filing that requested permission to enroll an
additional 240 patients and approval to implant the second eyes of the 118
patients already enrolled.
TYPE: EX-99.30
SEQUENCE: 2
DESCRIPTION: NEWS RELEASE DATED 8/27/1999
Exhibit 99.30
KeraVision Receives FDA Approval to Complete Phase III-B Patient Enrollment
Intacs (trademark) technology is studied for a wider range of myopia
Fremont, CA (August 27, 1999) -- KeraVision, Inc. (Nasdaq: KERA), the
vision correction company, said the Food and Drug Administration (FDA)
has approved an application allowing the company to finish enrolling
patients in the Intacs clinical trials for a wider range of myopia
treatment.
Intacs corneal ring segments, the first FDA-approved non-laser option
for surgically correcting nearsightedness, are now sold in the U.S. for
mild myopia (-1.0 to -3.0 diopters), a condition that affects an
estimated 20 million adult Americans. Intacs for very mild myopia
(-0.75 to -1.0 diopter) and moderate myopia (-3.0 to -4.5 diopters) are
now being evaluated in U.S. Phase III-B clinical trials.
KeraVision said it expects the last of the planned 360 patients will be
enrolled in the Phase III-B clinical trial by early 2000. After
completion of the patient enrollment, the company expects to apply
within one year for FDA pre-market approval (PMA) to sell Intacs for
these wider ranges of myopia.
If approved by the FDA for very mild and for moderate myopia, Intacs
could be a treatment option for about 90 percent of Americans who wear
eyeglasses and contacts for nearsightedness, according to industry
estimates.
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