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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: November 17, 1998
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 November 17, 1998, KeraVision, Inc. announced FDA Advisory Panel
will review KeraVision "Ring" application. Futher details regarding
this announcement are contained in the Company's new release dated
November 17, 1998, attached as exhibit hereto and incorporated by
reference herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(a) Exhibits:
99.10 KeraVision, Inc. News Release dated November 17, 1998.
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: November 20, 1998
3
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Exhibit 99.10
FDA Advisory Panel Will Review KeraVision "Ring" Application
Meeting Date Set For January 12, 1999
Fremont, CA (November 17, 1998) -- KeraVision, Inc. (Nasdaq: KERA), a
vision correction company, said that its Premarket Approval (PMA)
application for the company's initial product, the KeraVision
(Registered Trademark) Ring for myopia, will be reviewed January 12,
1999, by the Ophthalmic Devices Advisory Panel of the U.S. Food and
Drug Administration. The company was officially notified yesterday of
the date for the panel meeting.
If approved, the KeraVision Ring would become the first non-laser
surgical approach in the U.S. for treating nearsightedness (myopia),
opening the way for a new category of vision correction surgery that is
designed especially for treating low to moderate myopia. Based on
industry estimates, more than 22 million adult Americans are within
this range of nearsightedness.
KeraVision Chairman and Chief Executive Officer Thomas M. Loarie said,
"We believe the clinical results will demonstrate that the KeraVision
Ring is at least as safe and effective as other surgical treatments for
nearsightedness, with the unique advantage that the effect can be
reversed. KeraVision's approach is intended to give patients vision
correction without having to make a permanent choice."
Traditionally, FDA advisory panel meetings mark the beginning of the
final phase of regulatory review for new medical devices in the U.S.
Final FDA approval is subject to the panel recommendation, on-site
inspections of company facilities and clinical sites, and other
considerations.
U.S. Clinical Trials
Fifty-three percent of nearsighted patients achieved at least 20/16
vision with the KeraVision Ring (in other words, better than 20/20),
according to clinical results that were reported as part of the PMA
application. Seventy-four percent achieved 20/20 vision or better,
while 97 percent saw 20/40 or better -- the vision standard for
receiving a driver's license in most states. Clinical results were
based on 410 treatments that were performed at 11 clinical sites as
part of U.S. Phase II and Phase III studies. Patients were monitored
for one year following treatment.
The KeraVision treatment takes about 15 minutes and involves placing 2
clear, micro-thin, polymer segments in the eye outside of the central
optical zone. Unlike other surgical techniques to correct myopia,
KeraVision's approach does not require cutting or removing tissue from
the central optical zone, which is the critical area for clear vision.
KeraVision, founded in 1986, is creating a new category of non-laser
vision correction products that are designed especially for low to
moderate myopia (nearsightedness) and low 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 the KeraVision Ring for myopia, part of 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 the KeraVision Ring or the
surgical procedure, competitive products and technology, market
acceptance of the KeraVision Ring, 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
KeraVision Ring and
ICR are registered
trademarks or trademarks
of KeraVision, Inc. in
the U.S. and foreign
countries."
