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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 12, 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)
<PAGE>
ITEM 5. OTHER EVENTS
On November 4, 1998, Keravision, Inc. appoints faculty to new medical
education council. Further details regarding this announcement are
contained on the Company's new release dated November 4, 1998, attached
as exhibit hereto and incorporated by reference herein.
On November 9, 1998, KeraVision, Inc. announced non-laser treatment for
farsighted people could be alternative to eyeglasses, contacts,
"irreversible" techniques. Further details regarding this announcement
are contained in the Company's new release dated November 9, 1998,
attached as exhibit hereto and incorporated by reference herein.
On November 12, 1998, KeraVision, Inc. announced clinical results used
in PMA. Further details regarding this announcement are contained in
the Company's new release dated November 12, 1998, attached as exhibit
hereto and incorporated by reference herein.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(a) Exhibits:
99.7 KeraVision, Inc. News Release dated November 4, 1998.
99.8 KeraVision, Inc. News Release dated November 9, 1998.
99.9 KeraVision, Inc. News Release dated November 12, 1998.
2
<PAGE>
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 12, 1998
3
<PAGE>
Exhibit 99.7
KeraVision Appoints Faculty
to New Medical Education Council,
Will Train U.S. Surgeons In Use of Pioneering Myopia Product
Fremont, CA (November 3, 1998) -- KeraVision, Inc. (Nasdaq: KERA), a
vision correction company, today announced the formation of the
KeraVision Council on Medical Education and Standards made up of some
of the world's leading authorities on vision correction surgery.
The council will help develop and oversee surgeon training programs for
the KeraVision (Registered Trademark) Ring, which is in final review by
the U.S. Food and Drug Administration as the first non-laser approach
for surgically treating low to moderate myopia.
The council faculty includes George O. Waring III, MD, FACS, FRC Ophth
of Atlanta, who directed the National Eye Institute's 15 year PERK
study of radial keratotomy and is credited with introducing the
systematic study of LASIK vision correction technology in the U.S.;
Richard L. Lindstrom, MD, of Minneapolis, a prominent clinical
investigator and holder of 25 patents in ophthalmology; Daniel S.
Durrie, MD, of Kansas City, who has performed or assisted in over
25,000 excimer laser procedures and was one of the first U.S. surgeons
to correct nearsightedness with that technology; and David S.
Schanzlin, MD, of San Diego, a well-known educator and author who has
served as chief clinical investigator for the KeraVision Ring since
1993.
In addition, J. Randy Alexander, former president of U.S. operations
for Chiron Vision, was appointed council and faculty director.
KeraVision Chairman and Chief Executive Officer Thomas M. Loarie said,
"As we prepare for possible commercialization in the U.S., KeraVision's
total focus is on patient satisfaction. Surgeon training is a large
part of our commitment to making the KeraVision Ring synonymous in
consumers' minds with quality vision.
"We have assembled a medical faculty that we believe puts KeraVision at
the forefront of surgeon training in the ophthalmic field," Loarie
added.
Faculty for the KeraVision Council on Medical Education and Standards
includes:
David S. Schanzlin, MD, is a professor of ophthalmology at the
University of California at San Diego and director of keratorefractive
surgery at the UC Shiley Eye Center. In addition to serving as chief
clinical investigator for the KeraVision Ring, Dr. Schanzlin was
involved in the development of several other technologies and
ophthalmic techniques. He is the president of the International
Society of Refractive Surgery and has authored more than 100
publications, abstracts and book chapters on the cornea and vision
correction.
Daniel S. Durrie, MD, is director of refractive services at
Hunkeler Eye Centers in Kansas City, a clinical associate professor of
ophthalmology at Kansas University Medical Center and a clinical
assistant professor of ophthalmology at the University of Missouri at
Kansas City. He has been the principal clinical investigator and
medical monitor for numerous new technologies and was among the first
surgeons in the U.S. to correct nearsightedness with the excimer laser.
He is a frequent lecturer at international medical meetings and serves
on the editorial boards of the Journal of Corneal and Refractive
Surgery and several other publications.
Richard L. Lindstrom, MD, is a professor of ophthalmology at the
University of Minnesota and a corneal and refractive surgeon at the
Phillips Eye Institute in Minneapolis. The author of over 300 journal
articles and numerous books and book chapters, he also serves on the
editorial boards of five of the leading ophthalmic journals and
publications. He is the first person to receive the Lifetime
Achievement in Refractive Surgery Award from the International Society
of Refractive Surgery.
George O. Waring III, MD, FACS, FRC Ophth, is a professor of
ophthalmology at Emory University and co-founder and director of
refractive surgery at the Emory Vision Correction Center in Atlanta.
He also is co-developer of the Emory LASIK System which is the first
LASIK technology to receive a positive recommendation for approval from
the FDA Ophthalmic Devices Advisory Panel. Dr. Waring is the author of
three corneal text books, more than 60 book chapters, some 230 peer-
reviewed journal articles and over 250 other publications. He serves
on the editorial board of 15 journals and is the editor-in-chief of The
Journal of Refractive Surgery.
J. Randy Alexander, director of the KeraVision Council on Medical
Education and Standards, was responsible for helping direct the launch
of Chiron's excimer laser and for developing the LASIK technology into
the fastest growing area of vision correction surgery. During his 10
years at Chiron he served as vice president of sales and marketing and
senior vice president of business and technology development in
addition to serving as president of US operations.
KeraVision, founded in 1986, is creating a new category of vision
correction with its KeraVision Ring, a non-laser treatment that is
designed to correct vision especially for people with low to moderate
myopia (nearsightedness). Presently under FDA review, this approach is
a potential alternative to eyeglasses, contact lenses and vision
correction surgeries that permanently alter the eye's central optical
zone. In addition to treating myopia, KeraVision's patented core
technology is being developed to possibly 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, 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
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 Ring and
ICR are registered
trademarks or trademarks
of KeraVision, Inc. in
the U.S. and foreign
countries
<PAGE>
Exhibit 99.8
Non-Laser Treatment for Farsighted People
Could Be Alternative to Eyeglasses, Contacts, "Irreversible" Techniques
KeraVision Plans To Expand Clinical Study to U.S., Canada, Europe
New Orleans (November 9, 1998) -- Eighty-five percent of farsighted
(hyperopic) patients were able to see with 20/20 vision or better and
all 100 percent had vision of 20/40 or better after being treated with
an experimental non-laser approach to vision correction surgery,
according to clinical results from a hyperopia study that were reported
at an American Academy of Ophthalmology (AAO) meeting in New Orleans.
20/40 is the vision standard for receiving a driver's license in most
states.
The experimental product, which is under development outside the U.S. by
KeraVision, Inc. (Nasdaq: KERA) of Fremont, CA, could offer the first
reversible, non-laser surgical treatment for the estimated 20 million
adult Americans who live with low to moderate farsightedness.
KeraVision intends next year to launch additional hyperopia studies at
clinical sites in the U.S., Canada and Europe.
"While these results are preliminary, KeraVision could some day offer
the possibility for permanent correction without the patients having to
make a permanent choice," said Arturo S. Chayet, MD, of San Diego, a
clinical investigator and ophthalmologist who performed the initial
study in Mexico. "So far, my patients are pleased with their correction,
their rapid recovery and the added potential benefit of reversibility.
I think this technology eventually could be a valuable new tool for
surgeons in an emerging field of vision correction."
The advantage of a reversible, non-laser approach to vision correction
would be patients' freedom to have their correction changed as their
eyesight changes with age, or even to take advantage of future
advancements in vision correction. KeraVision has developed a similar
non-laser treatment for nearsightedness (myopia), called the KeraVision
(registered trademark) Ring. That product is currently sold in Canada
and in several European countries and is under final review by the FDA
for possible commercial use in the U.S.
Chayet's report, which was delivered at an AAO meeting on Saturday,
November 7, was based on clinical results for 13 patients who were
monitored for one month following surgery. These results were achieved
with an improved KeraVision design that demonstrated better results that
those achieved for Chayet's first group of patients.
Possible commercial approval could be several years away.
Longer Term Visual Stability Reported for First Group
When treated with the earlier KeraVision product design, 14 farsighted
patients continued to experience visual stability six months after their
treatment; 71 percent of them saw 20/20 or better and 100 percent saw
20/40 or better, which is the vision standard for receiving a driver's
license in most U.S. states. Chayet also reported one-year clinical
data for the original four KeraVision hyperopia patients: 50 percent saw
20/20 vision or better and 100 percent saw 20/40 or better.
Chayet added, "KeraVision's hyperopia technology will require further
study, but at this stage it appears to offer some of the same advantages
as their myopia product: good correction and fast visual recovery
without any harm to the central optical zone."
KeraVision's hyperopia product consists of several micro-thin inlays
that are placed in the cornea but outside of the central optical zone.
Unlike excimer laser procedures, the KeraVision treatment does not
permanently alter the central optical zone, which is the critical area
for clear vision. The inlays are placed or removed during a brief,
outpatient procedure using anesthetic eyedrops.
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 experimental product or the surgical
procedure, competitive products and technology, market acceptance of the
experimental product, 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."
* * * * * *
Renee Keller
Shareholder Relations
KeraVision, Inc.
(510) 353-3000
<PAGE>
Exhibit 99.9
Clinical Results Used In PMA Filing Are Reported By KeraVision
Over half of patients improved to at least 20/16 vision -- or better
than 20/20
New Orleans (November 12, 1998) -- A unique non-laser surgical approach
being developed by KeraVision, Inc. (Nasdaq: KERA) to treat low to
moderate myopia resulted in 20/20 vision or better for 74 percent of
patients and at least 20/40 vision for 97 percent of those in a U.S.
clinical trial, it was reported yesterday at the American Academy of
Ophthalmology (AAO) annual meeting in New Orleans.
Clinical results for the KeraVision (Registered Trademark) Ring, the
most extensive so far, are based on data submitted earlier this year to
the Food and Drug Administration as part of KeraVision's Premarket
Approval (PMA) application for the product. The results were from 410
KeraVision Ring treatments that were included in the U.S. Phase II and
Phase III studies that were performed at 11 clinical sites. Patients
were monitored for at least one year to assess the safety and efficacy
of the treatment.
Fifty-three percent of the study group improved to at least 20/16 -- in
other words, better than 20/20 vision.
"The KeraVision Ring appears to safely and effectively correct myopia,
with the added benefit that we can reverse the effect," reported George
O. Waring III, MD, FACS, FRC Ophth, who is an internationally noted
clinical investigator, author and professor of ophthalmology at Emory
University. He was also instrumental in the clinical evaluation and
commercial acceptance of the LASIK method of vision correction.
"Reversibility means that people can have permanent correction without
making a permanent choice. The KeraVision Ring creates a new category
of non-laser vision correction."
Waring added that this is the first surgical procedure that is designed
especially for low to moderate myopia (in clinical terms, -1.0 to -3.5
diopters). According to industry estimates, more than 22 million adult
Americans are within this range of nearsightedness and are potential
candidates for the KeraVision Ring.
Final FDA Review Is Pending
In August, the FDA accepted for "filing" the company's Premarket
Approval (PMA) application for the KeraVision Ring. That action
triggered the final phase of regulatory review for possible commercial
approval in the U.S. The KeraVision Ring for myopia is currently sold
in Canada and in several European countries.
What makes the KeraVision procedure unique is that it is designed to
reshape the cornea -- thereby correcting how light rays reach the retina
- -- without cutting or removing tissue from the central optical zone.
The advantage is that the treatment may be reversed, giving people
freedom to have their correction changed if their eyesight changes
because of age, or to take advantage of future advancements in vision
correction. Excimer laser procedures to correct vision are
irreversible, according to the medical literature.
KeraVision is developing a similar non-laser treatment that is intended
to correct farsightedness (hyperopia). Preliminary clinical results for
that international study were reported at an AAO-sponsored meeting on
November 6, showing that 85 percent of KeraVision's patients achieved
20/20 vision or better and 100 percent achieved 20/40 or better. These
preliminary results are based on 13 patients who were treated for low to
moderate hyperopia and monitored for one month.
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."
