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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: September 3, 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 August 27, 1999, KeraVision, Inc. Receives FDA Approval to Complete
Phase III-B Patient Enrollment. Further details regarding this announcement are
contained in the Comapny's news release dated August 27, 1999 attached as
exhibit hereto and incorporated reference herein.
On September 2, 1999, KeraVision, Inc. Completes Stock Transaction. Further
details regarding this announcement are contained in the Comapny's news release
dated September 2, 1999 attached as exhibit hereto and incorporated reference
herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(a) Exhibits:
99.30 KeraVision, Inc. News Release dated August 27, 1999
99.31 KeraVision, Inc. News Release dated September 2, 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: September 3, 1999
3
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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.
In another clinical study for potential new Intacs products,
a fifth clinical site has been added to KeraVision's European hyperopia
feasibility trials. Josep Guell, MD, of the Institute of Ocular
Microsurgery in Barcelona, Spain, will use Intacs to treat up to 20
patients for mild and moderate farsightedness (+1.0 to +5.0 diopters of
hyperopia). Other Intacs hyperopia study sites are in Austria and
Germany. As previously announced, KeraVision plans next year to apply
for "CE" mark approval to sell Intacs for hyperopia in the European
Union countries.
KeraVision, founded in 1986, is the developer of Intacs, the first FDA-
approved non-laser option for surgically treating mild myopia
(nearsightedness). Intacs are an 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 and moderate 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 KeraVision's ability
to obtain regulatory approvals, market acceptance of KeraVision Intacs,
complications relating to the product or the surgical procedure,
competitive products and technologies, and other risk factors listed
from time to time in KeraVision's filings with the Securities and
Exchange Commission.
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
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Exhibit 99.31
KeraVision, Inc. Completes Stock Transaction
FREMONT, CA (September 2, 1999) - KeraVision, Inc. (Nasdaq: KERA), the
vision correction company, said today that it has sold 600,000 shares of
its common stock at a price of $13.00 per share, pursuant to the
exercise by the underwriters of their over-allotment option in
connection with the underwritten offering of KeraVision's common stock.
KeraVision previously sold 4,000,000 shares of its common stock in the
initial closing of the offering on August 17, 1999. The offering was
underwritten by Donaldson, Lufkin & Jenrette; Dain Rauscher Wessels, a
division of Dain Rauscher Inc.; Prudential Vector Healthcare Group, a
unit of Prudential Securities; and SG Cowen.
All of the shares were issued and sold by KeraVision. The net proceeds
of approximately $7,332,000 from the sale of 600,000 shares will be used
by KeraVision for sales and marketing efforts related to the U.S. launch
of Intacs (trademark) corneal ring segments, the continued development
and clinical testing of products based on the Intacs technology,
prepayment of short-term debt and for working capital and other general
corporate purposes.
KeraVision is developing a new category of non-laser vision correction
products for the treatment of common vision disorders, including myopia
(nearsightedness), hyperopia (farsightedness) and astigmatism, to offer
an alternative to eyeglasses, contact lenses and other vision correction
surgical procedures. KeraVision's initial product, Intacs, has been
approved by the FDA for correcting mild myopia.
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.
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
