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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 14, 1999
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 13, 1999, KeraVision, Inc. announced FDA Panel approvals
with conditions for KeraVision Intacs, a non -laser treatment for myopia.
Further details regarding this announcement are contained in the Company's
new lease dated January 13, 1999 attached as exhibit hereto and
incorporated reference herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(a) Exhibits:
99.12 KeraVision, Inc. News Release dated January 13, 1999.
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 14, 1999
3
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Exhibit 99.12
FDA Panel Recommends
Approval With Conditions for KeraVision Intacs, a Non-Laser Treatment
for Myopia
Product Is Designed to Restore Vision Without Glasses, Contacts
Fremont, CA (January 13, 1999) -- KeraVision, Inc. (Nasdaq: KERA),
developer of a non-laser vision correction product for treating myopia,
announced that the Ophthalmic Devices Panel of the U.S. Food and Drug
Administration (FDA) has recommended approval with conditions for the
company to sell its initial product, IntacsT, to treat nearsightedness.
The panel, whose conditions had to do with labeling changes and a post-
market surveillance study, issued its recommendation yesterday in
Washington, DC.
Subject to final FDA approval, Intacs (known during clinical studies as
the KeraVision Ring, or Intrastromal Corneal Ring) would become the
first approved non-laser surgical treatment in the U.S. that is
designed especially for people with -1.0 to -3.5 diopters of myopia,
which effects an estimated 22 million adult Americans.
KeraVision Chairman and Chief Executive Officer Thomas M. Loarie said,
"Intacs are designed to offer the convenience of surgical vision
correction and the peace of mind of being reversible in most but not
all cases. This is the beginning, we believe, of a new category of
vision correction that gives people the possibility of permanent
correction without making a permanent choice."
Unlike laser procedures, Intacs are intended to reshape a cornea's
curvature and correct vision by adding material to the eye, not by
cutting or removing tissue. Intacs are designed to be surgically
inserted without harming the eye's central optical zone.
Loarie added, "In our view, Intacs represent a technological
breakthrough that can only heighten consumer interest in what already
is a rapidly growing vision correction surgery market. KeraVision has
created what we believe is a unique solution for a major segment of
nearsighted adults."
Results of U.S. Clinical Studies
In clinical studies, 98 percent of patients achieved 20/40 vision or
better with Intacs. A total of 78 percent of Intacs patients achieved
20/20 or better and 56 percent achieved 20/16 or better. Results at the
end of one year of clinical follow-up were based on 410 treatments for
- -1.0 to -3.5 diopters of myopia. The treatments were performed at 11
clinical sites as part of U.S. Phase II and Phase III studies.
Intacs to treat -1.0 to -5.0 diopters of myopia are presently sold in
Canada and in several European countries.
The company noted that the FDA panel recommendation is advisory only,
and that the FDA is not bound by the recommendation.
KeraVision, founded in 1986, is creating a new category of non-laser
vision correction products that are designed especially for mild to
moderate myopia (nearsightedness) and potentially for mild to moderate
hyperopia (farsightedness). These products are potential alternatives
to eyeglasses, contact lenses and vision correction surgeries that
permanently alter the eye's central optical zone. The initial product
is KeraVision Intacs for myopia, developed from a technology platform
that the company believes will potentially treat the most common forms
of vision problems.
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 significant
unforeseen delays in the regulatory approval process, changes in
regulatory review guidelines, procedures, regulations or administrative
interpretations, complications relating to KeraVision Intacs or the
surgical procedure, competitive products and technology, market
acceptance of KeraVision Intacs, and other risk factors described under
the heading "Factors Affecting the Company, Its Business and Its Stock
Price" set forth in the company's Annual Report on Form 10-K for the
year ended December 31, 1997 and on Form 10-Q for the quarter ended
September 30, 1998.
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, KeraVision Ring
and ICR are registered
trademarks or trademarks
of KeraVision, Inc. in
the U.S. and foreign
countries
