Current Report — Form 8-K
Filing Table of Contents
Document/Exhibit Description Pages Size
1: 8-K Current Report 3 13K
2: EX-99.16 News Release Dated 4/12/99 3± 14K
3: EX-99.17 News Release Dated 4/12/99 3± 13K
4: EX-99.18 News Release Dated 4/12/99 3± 13K
5: EX-99.19 News Release Dated 4/14/99 2± 12K
6: EX-99.20 News Release Dated 4/15/99 3± 13K
7: EX-99.21 News Release Dated 4/15/99 2± 12K
EX-99.19 — News Release Dated 4/14/99
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Exhibit 99.19
KeraVision Presents One-Year Clinical Data On Intacs (trademark) for Hyperopia
Potential product is based on same technology as Intacs (trademark) for
myopia, approved April 9 by FDA
Seattle (April 14, 1999) -- A possible new non-laser option for
surgically treating farsightedness (hyperopia) resulted in 20/25 vision
or better for 91 percent of patients in a small clinical study, it was
announced Tuesday at the annual meeting of the American Society of
Cataract and Refractive Surgery (ASCRS) in Seattle.
KeraVision (registered trademark) Intacs for hyperopia -- an
investigational product under development outside the U.S. by
KeraVision, Inc. (Nasdaq: KERA) of Fremont, CA -- are designed as a
possible option to eyeglasses, contacts and laser refractive surgery.
They are based on the same patented technology as Intacs for myopia,
which on April 9 became the first FDA-approved non-laser surgical
option for treating mild nearsightedness.
"The advantage of non-laser treatment is that a patient's central
optical zone does not have to be compromised," said Arturo S. Chayet,
MD, of San Diego, a clinical investigator and ophthalmologist who
performed this initial study in Mexico. "By adding material to the
cornea, Intacs appear to reshape the cornea's curvature without the need
to cut or remove tissue from the central optical zone. If successful,
Intacs will create an entire new category for treating mild hyperopia."
In the Mexico study, 55 percent of patients achieved 20/20 vision or
better, 91 percent saw 20/25 or better, and 100 percent saw 20/40 or
better (the vision standard in most U.S. states for receiving a driver's
license). Clinical data are from 11 patients who were treated for mild
farsightedness (+1.0 to +3.5 diopters of correction) and monitored for
one year.
Chayet told the medical conference that Intacs for hyperopia appeared to
provide his patients with excellent visual outcomes, rapid visual
recovery and minimal discomfort during surgery. The product can also be
removed if a patient's correction requirements change with age.
With hyperopia, or farsightedness, people have trouble seeing objects
that are close. The condition results when the cornea is too flat,
causing light rays to focus behind the retina and producing a blurred imaged.
Clinical Trial Expanded to Europe
In January, KeraVision added a new hyperopia clinical study site in
Europe -- at Neubrandenburg, Germany, where 12 Intacs treatments have
been completed. Two more sites are expected to be added in April -- at
Munich and Fuerth im Wald. If positive clinical results continue,
KeraVision plans to apply for European Union regulatory approval within
two years. The company also plans to initiate an FDA-regulated clinical
study in the U.S.
Intacs for hyperopia are tiny, clear, precision-engineered, polymer
inlays that are placed in the periphery of the cornea but outside of the
central optical zone (the dome-shaped "window" at the front of the eye
and the critical area for clear vision). They are designed to reshape a
cornea's curvature by adding material to the eye instead of by cutting
or removing tissue from the optical zone as with other vision correction
surgery procedures.
KeraVision, founded in 1986, is creating a new category of non-laser
vision correction products that are designed especially for low myopia
(nearsightedness) and possibly for low hyperopia (farsightedness) as
well as astigmatism. 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 Intacs corneal ring segments 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 "Risk Factors Affecting the Company, Its
Business and Its Stock Price" set forth in the company's Form 10-K for
the year ended December 31, 1998 and in 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
the U.S. and foreign
countries."
Dates Referenced Herein and Documents Incorporated by Reference
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