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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: January 20, 2000
Commission File Number: 0-26208
================================================================================
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 January 18, 2000, KeraVision, Inc. Announced To Develope Intacs for
Possible Treatment of Keratoconus Corneal Thinning Disease. Further details
regarding this announcement are contained in the Company's news release dated
January 18, 2000 attached as exhibit hereto and incorporated reference herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(a) Exhibits:
99.35 KeraVision, Inc. News Release dated January 18, 2000
2
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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: January 20, 2000
3
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Exhibit 99.35
KeraVision to Develop Intacs for Possible Treatment of Keratoconus Corneal
Thinning Disease
Clinical trials scheduled for five European medical sites
FREMONT, CA (January 18, 2000) -- KeraVision, Inc. (Nasdaq: KERA),
developer of Intacs corneal segments for the treatment of
nearsightedness, has begun clinical trials in Europe using the company's
patented Intacs technology as a possible treatment for keratoconus, a
progressive thinning-of-the-cornea disorder. Keratoconus affects an
estimated 272,000 Americans and approximately 370,000 people in the
European Union, or about one person in 1,000, according to some experts'
estimates.
Intacs for keratoconus are based on the same patented technology used in
KeraVision's initial product, Intacs for mild nearsightedness, or
myopia, which the Food and Drug Administration approved in 1999 for sale
in the U.S.
KeraVision Chairman and Chief Executive Officer Thomas M. Loarie said,
"KeraVision has been encouraged by the initial clinical results of
European surgeons, led by Dr. Joseph Colin in France, who have been
using Intacs in their own independent keratoconus studies. It appears
that Intacs may be useful in treating not only keratoconus but other
vision disorders caused by thinning of the cornea."
Keratoconus results in thinning and bulging of the cornea that can lead
to blindness. Current treatments include contact lenses, nutritional
therapies and corneal transplants.
"Keratoconus is a disorder that so far has eluded an effective
treatment," said Joseph Colin, MD, professor and chairman of
ophthalmology at Brest University, Brest, France. Dr. Colin, who in 1997
performed the world's first Intacs treatment on a keratoconus patient
and has reported his clinical data at numerous medical conferences since
then, added, "By building up the cornea and restoring a more natural
curvature, Intacs may help prolong the ability of these patients to see
with glasses and contacts and possibly delay or eliminate their need for
corneal transplants. Results with Intacs are very preliminary but appear
promising."
Arthur B. Epstein, OD, FAAO, who is a leading authority on keratoconus
and director of contact lens services at North Shore University Hospital
- - New York University School of Medicine, said, "With the increasing
interest in vision correction procedures and advances in diagnostic
technologies, we are finding that the incidence of corneal thinning
disorders including keratoconus may be more than double what was
previously thought. This is why KeraVision's leading-edge work is so
important."
Intacs consist of clear, ultra-thin, precision-engineered polymers that
are placed in the periphery of the cornea (the dome-shaped "window" at
the front of the eye) during a brief outpatient procedure. By adding
material to the eye, Intacs are designed to remove irregularities in
the cornea's curvature and change the way light rays reach the retina,
thereby correcting vision.
The keratoconus trials are expected to involve a total of 40 patients at
five medical sites in Brest, France; Manchester, England; Munich,
Germany; and two sites in Milan, Italy. Subject to clinical results,
KeraVision could apply as early as this year for European approval to
sell Intacs for the treatment of keratononus throughout the European
Union. Plans for possible U.S. clinical trials have not been determined.
Other clinical trials involving Intacs include hyperopia
(farsightedness) studies in Europe and Phase III myopia
(nearsightedness) studies in the U.S. for a potentially wider range of
correction than originally approved by the FDA. KeraVision already
received FDA approval to sell Intacs for mild myopia, which affects an
estimated 22 million Americans.
KeraVision, founded in 1986, is the developer of Intacs for the
treatment of myopia, which was named one of "The Year's Top 10 Medical
Advances" by CNN and Health magazine. Intacs, the first FDA-approved
non-laser option for surgically treating mild myopia, or
nearsightedness, 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 contained in Form 10-Q for the quarter ended Sept. 30,
1999, and under the heading "Risk Factors" in the registration
statement on Form S-3 dated Aug. 12, 1999, as well as in other SEC
filings.
# # #
Note to Editors: Intacs are a registered trademark or trademark of
KeraVision, Inc. in the U.S. and foreign countries
Contact:
KeraVision, Inc., Fremont
Mark Fischer-Colbrie, 510/353-3000 (Investors)
Mick Taylor, 510/353-3075 (Media)
www.keravision.com
Fax on Demand, 800/448-8559
