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Total Number of Pages: 3
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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report: October 29, 1999
Commission File Number: 0-26208
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KERAVISION, INC.
(Exact name of Registrant as specified in its Charter)
DELAWARE 77-0328942
(State of Incorporation) (I.R.S. Employer
Identification No.)
48630 MILMONT DRIVE
FREMONT, CA 94538
(Address of principal executive offices)
(510) 353-3000
(Registrant's telephone number)
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ITEM 5. OTHER EVENTS
On October 28, 1999, KeraVision, Inc. Reported Two-Year Clinical Results
for Intacs Correction of Myopia is Stable. Further details regarding this
announcement are contained in the Comapny's news release dated October 28, 1999
attached as exhibit hereto and incorporated reference herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(a) Exhibits:
99.33 KeraVision, Inc. News Release dated October 28, 1999
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the Registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
KERAVISION, INC.
/s/Mark Fischer-Colbrie
-----------------------
Mark Fischer-Colbrie
Vice President, Finance and
Administration and Chief Financial
Officer(Principal Financial and
Accounting Officer)
Date: October 29, 1999
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Exhibit 99.33
KeraVision Reports Two-Year Clinical Results for Intacs (trademark);
Correction of Myopia is Stable
Quality of vision is demonstrated by WaveFront Analysis
ORLANDO, FLA (October 28, 1999) - Intacs, which are the first FDA-
approved non-laser option for surgically correcting nearsightedness,
showed stable correction two years after treatment - with 76 percent
of treated eyes seeing at least 20/20, 55 percent seeing 20/16 or
better, and 21 percent seeing at least 20/12, it was announced here
yesterday at the annual meeting of the American Academy of
Ophthalmology. Intacs are made by KeraVision, Inc. (Nasdaq: KERA) of
Fremont, CA, which pioneered the category of non-laser vision
correction surgery.
"Clinical data from the FDA trials show that Intacs are effective in
correcting mild myopia and are safe, well-tolerated in the eye, and
stable over time," said David J. Schanzlin, professor of
ophthalmology at the University of California in San Diego and chief
medical investigator for the Intacs clinical trials. "The fact that
Intacs can be removed and that the wearer's prescription can be
exchanged much like contacts and glasses is a major advance for the
consumer."
In other AAO highlights:
- -- To illustrate how Intacs eyes are different from other surgically-
corrected eyes, Schanzlin reported the results of a WaveFront
Analysis, an emerging diagnostic tool that measures light rays as
they pass through the lens of an eye and onto the retina. Analysis
shows that wavefronts in Intacs eyes are consistent with quality
vision, Schanzlin said. He added, "We believe this occurs because
Intacs, unlike laser procedures, preserve the natural shape of the
cornea which appears to be a critical element of overall quality of
vision."
- -- More than four out of five Intacs removals (or 86 percent) were
for problems that potentially could be fixed by replacement with
another Intacs size, including visual symptoms, under- and over-
corrections, and astigmatism. Only one-10th of one percent (0.1) of
cases were safety-related out of a total removal rate to date of six
percent of Intacs treatments.
In Schanzlin's presentation, the two-year clinical results were based
on 358 Intacs treatments that were performed at 11 medical sites as
part of U.S. Phase II and Phase III studies. Intacs wearers were
treated for -1.0 to -3.0 diopters of myopia, or mild nearsightedness
- - a condition that affects an estimated 20 million adult Americans.
People who are mildly nearsighted generally require glasses or
contacts for routine tasks like driving, watching a movie or seeing
an alarm clock.
KeraVision, founded in 1986, is the developer of Intacs, the first
FDA-approved non-laser option for surgically treating mild myopia
(nearsightedness). Intacs are a safe and effective alternative to
eyeglasses, contact lenses and vision correction surgeries that
permanently alter the eye's central optical zone. The company's
patented technology platform is also being developed for the
possible treatment of other common vision problems including mild
hyperopia (farsightedness) and astigmatism.
Except for the historical information, the matters discussed in this
news release are forward-looking statements. Actual results may
differ materially due to a variety of factors, including market
acceptance of KeraVision Intacs, complications relating to the
product or the surgical procedure, competitive products and
technologies, and other risk factors described under the heading
"Risk Factors Affecting the Company, Its Business and Its Stock
Price" set forth in Form 10-Q for the quarter ended June 30, 1999,
and Form 10-K for the year ended December 31, 1998, as well as in
other SEC filings.
For further information:
Investors: Mark Fischer-Colbrie (510) 353-3000
Media: Mick Taylor (510) 353-3075
KeraVision, Inc.
48630 Milmont Drive
Fremont, CA 94538-7353
Fax: (510) 353-3030
www.keravision.com
"Fax on Demand"
(800) 448-8559
Intacs are a registered trademark or trademarks of KeraVision, Inc.
in the U.S. and in foreign countries.
