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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: February 18, 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 February 16, 1999, KeraVision, Inc. announced Intacs (Trademark),
KeraVision's Non-Laser Product for Nearsightedness Clears Another FDA
Milestone. Further details regarding this announcement are contained
in the Company's new release dated February 16, 1999 attached as exhibit
hereto and incorporated reference herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(a) Exhibits:
99.15 KeraVision, Inc. News Release dated February 16, 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: February 18, 1999
3
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Exhibit 99.15
Intacs (Trademark), KeraVision's Non-Laser Product for Nearsightedness,
Clears Another FDA Milestone
Pre-Market Approval (PMA) Application Deemed "Approvable" by FDA
Fremont, CA (February 16, 1999) -- KeraVision, Inc. (Nasdaq: KERA), the
vision correction company, said that its Pre-Market Approval (PMA)
application to sell Intacs (Trademark), a non-laser alternative for
treating myopia, has been deemed "approvable" by the U.S. Food and Drug
Administration (FDA).
By elevating KeraVision's application to "approvable" status, Intacs
can be considered a step closer to receiving possible final FDA
approval. The FDA action comes a month after the FDA's Ophthalmic
Devices Panel unanimously recommended approval, with conditions, of
Intacs for myopia.
KeraVision Chairman and Chief Executive Officer Thomas M. Loarie said,
"KeraVision is gratified by the FDA's prompt action. We very much
look forward to competing in the U.S. market with what is potentially
the first approved non-laser approach for treating mild to moderate
myopia."
Intacs (known during clinical studies as the KeraVision Ring, or
Intrastromal Corneal Ring Segments) consist of clear, ultra-thin
polymers that reshape the cornea when placed in the eye and outside of
the central optical zone. The Intacs treatment does not require
cutting or removing tissue from the optical zone like other surgical
procedures.
In a clinical study, nearly four out of five Intacs patients achieved
at least 20/20 vision, and more than half saw better than 20/20 based
on clinical results submitted in KeraVision's PMA application.
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, on Form 10-Q for the quarter ended
September 30, 1998 and 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 trademark
of KeraVision, Inc. in
