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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 1, 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 August 26, 1998, KeraVision, Inc. announced Premarket Approval (PMA)
application is accepted for filing. Further details regarding this
announcement are contained in the Company's new release dated
August 27, 1998, attached as exhibit hereto and incorporated by
reference herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(a) Exhibits:
99.4 KeraVision, Inc. News Release dated August 26, 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: September 1, 1998
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Exhibit 99.4
KeraVision, Inc. Press Release dated August 26, 1998.
Pioneering "Ring" Technology for Nearsighted People
To Receive Full PMA Review By FDA
KeraVision's Premarket Approval (PMA) application is accepted for
filing
Fremont, CA (August 26, 1998) -- After seven years of clinical study
and more than 1,500 treatments of nearsighted patients, KeraVision,
Inc. (Nasdaq: KERA) said that its pioneering "ring" for correcting
myopia has cleared a major regulatory hurdle in the U.S. The Food and
Drug Administration (FDA) this week filed the company's Premarket
Approval (PMA) application for the product, triggering the final phase
of regulatory review for possible commercial approval in the U.S.
The KeraVision(registered trademark) Ring is a pair of clear, thin,
feather-light polymer inlays that are placed in the eye during a 15-
minute procedure. The treatment is designed to correct
nearsightedness, or myopia, by altering the corneal curvature.
If approved for use in the U.S., the precision-engineered KeraVision
Ring will become the first surgical treatment that is designed to treat
myopia without permanently altering the optical zone. Instead of
cutting or removing tissue from the central cornea like other surgical
treatments, the KeraVision system reshapes the cornea by adding
material outside the optical zone -- and thereby leaving this critical
area for clear vision undisturbed.
KeraVision Chairman and Chief Executive Officer Thomas M. Loarie said,
"We believe KeraVision is creating a new category of vision correction
that combines the benefits of glasses, contacts and standard methods of
vision surgery. People want the possibility for permanent,
maintenance-free vision correction, but they also want the option for
removal and change if desired. The KeraVision Ring allows the
potential for both."
Loarie added, "With this FDA decision, we believe the company is a
major step closer to selling in the U.S. market. Subject to final
approval, KeraVision can begin building a vision care business based on
a unique technology that will serve the largest segment of the myopia
market. To appeal to the broadest range of contact lens and eyeglass
wearers, we are also working to leverage our research investment by
developing potential new treatments for astigmatism, hyperopia and a
wider range of myopia."
FDA acceptance of the company's PMA submission does not guarantee that
the product will be approved for sale in the U.S. One of the next
steps in the review process will include meeting with an FDA Ophthalmic
Devices Advisory Panel in Washington, D.C., where clinical data from
KeraVision's myopia study will be formally presented. Premarket
approval to sell the product in the U.S. is subject to the advisory
panel's recommendation and a number of regulatory steps, including FDA
inspections of the company's manufacturing facility and clinical study
sites.
Clinical Results for the KeraVision Ring Continue To Be Excellent
Fifty-one percent of nearsighted patients obtained 20/16 vision or
better, 70 percent obtained 20/20 or better, and 95 percent obtained
20/40 or better (the vision standard for receiving a driver's license
in most states), according to recent clinical data. These results,
which were announced in July at the International Society of Refractive
Surgery, are from a U.S. Phase III study of 350 people who were treated
for -1.0 to -3.5 diopters of myopia.
Highlights of clinical results to date include:
Excellent visual outcomes
Rapid visual recovery
Potential for adjustment and/or removal because the optical zone is
untouched
15-minute treatment that is performed with topical eye drop
anesthesia
At some point in the future the company plans to submit a PMA
supplement for approval of additional sizes of the KeraVision Ring
which are now in a U.S. Phase III clinical study. These additional
sizes would expand the total treatment range to cover -0.5 to -5.0
diopters of myopia -- a range that includes people who wear glasses or
contacts to drive or watch a movie, as well as those who can't see
clearly past arm's length without glasses or contacts.
Since 1991, more than 1,500 KeraVision Ring myopia treatments have been
performed as part of U.S. and international clinical studies. The
myopia ring is the first product to arise from KeraVision's "additive"
vision correction system, in contrast to the "ablative" approach to
corneal reshaping used in standard laser surgeries.
KeraVision is pioneering a new approach to treating common vision
problems, one that seeks to reshape the cornea by surgically adding
materials rather than cutting or removing tissue as other surgical
methods do. The company believes its approach will be an alternative
to eyeglasses, contacts and vision correction surgeries that
permanently alter the eye. In addition to treating myopia,
KeraVision's patented core technology is also being developed to
potentially treat 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 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, 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 factors described
in the quarterly report on Form 10-Q for the period ended June 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 and ICR are registered
trademarks or trademarks of
KeraVision, Inc. in the U.S.
and foreign countries
