As it Extends WJ Offer,
CIBA Vision Sees Restructuring
With shareholders awaiting the outcome of CIBA Vision’s plans to acquire
Wesley Jessen VisionCare, the Swiss health-care giant Novartis AG moved
to restructure its CIBA Vision unit to concentrate on its vision correction
business.
The move would place CIBA Vision pharmaceuticals under one of three
new divisions in the Novartis fold. Under the new structure, CIBA Vision
will continue to focus on vision correction, including contact lenses,
lens care products and ophthalmic surgical devices. It includes WJ’s operations
when the acquisition is complete. That would make CIBA Vision number two,
behind Johnson & Johnson, in the global contact lens market.
CIBA Vision spokeswoman Kristie Madara says the synergies with Novartis,
including research and development resources, sales and marketing, could
lead to the development of additional ophthalmic drugs.
In probably the final chapter of the Wesley Jessen merger saga, Novartis
offered in June to acquire WJ at the 11th hour of a hostile takeover bid
by Bausch & Lomb. Before B&L’s offer, WJ had announced plans to
merge with Ocular Sciences and has since paid that company a $25 million
termination fee.
CIBA’s offer to acquire the remaining outstanding WJ shares was to have
expired on July 25, but the company extended the offer until midnight August
23.
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Optometry Mourns Loss of Rodger
Kame
Noted author and lecturer Rodger T. Kame, O.D., of Los Angeles, died on
July 11, 2000, after a lengthy battle against cancer. He was 61.
Dr. Kame earned worldwide recognition as an expert in cornea and contact
lens research. He published more than 50 articles, papers and textbook
chapters, including some original clinical discoveries; presented more
than 250 lectures internationally; and served on several industry advisory
panels. He was a member of Review of Optometry’s editorial review board.
Dr. Kame was one of two people to chair both the AOA’s Contact Lens
Section (1993-1994) and the American Academy of Optometry’s Section on
Cornea and Contact Lenses (1987-1989). He received numerous awards, the
most recent of which was the AOA Contact Lens Section’s Achievement Award
in 1998. Dr. Kame also served as an adjunct professor at Southern California
College of Optometry, from which he graduated in 1962.
Dr. Kame’s middle son, Gregory, a 1999 graduate of SCCO, has taken over
his father’s 33-year-old Los Angeles practice. His youngest son, Russell,
is the optician in charge of the dispensary. Dr. Kame is also survived
by his wife Kazie, his oldest son Brad, and his daughter-in-law, Anna Sun
Kame, O.D. (Gregory’s wife).
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Lab-Grown Corneal Grafts
May be for Extreme Cases Only
John Murphy
Senior Editor
Two different research teams have bioengineered corneal transplants.
At University of California Davis, a team led by a dermatologist and an
ophthalmologist created lab-grown corneal transplants that improved or
restored eyesight in 10 out of 14 patients.1 A team in Taiwan improved
the mean visual acuity from 20/112 to 20/45 among 5 out of 6 patients.2
The results are promising, but lab-grown corneal grafts are only for
extreme cases—patients who have failed with conventional corneal transplants
or are not candidates for them, says UC Davis ophthalmologist Ivan R. Schwab.
More research must be done before it becomes a first-line treatment, he
says.
At this time, the procedure is appropriate for only a few thousand Americans
with severe corneal involvement, including those with tumors or disorders
such as pemphigoid and Stevens-Johnson syndrome, inherited syndromes such
as aniridia, or with severe injuries such as a chemical, fire or radiation
burn.
Eventually, bioengineers may be able to produce ready-made, “off-the-shelf”
corneal grafts that are easily transplanted, Dr. Schwab says.
The procedure builds on research on two kinds of bioengineered tissues:
lab-grown skin and lab-grown cartilage. In the UC Davis study, the researchers
took a corneal biopsy from the patient’s healthy contralateral eye or from
the eye of a relative. They then removed stem cells from the biopsies.
(Corneal stem cells produce healthy new cells that repair or replace
weaker cells.)
The stem cells were fed and grew to produce a thin film of corneal cells.
These were transferred onto human amniotic membranes. As the tissues grew
in thickness, they became sturdy enough to be grafted onto the patient’s
eye after the eye’s damaged tissue was removed. The patients healed, and
follow-up was completed within 6-19 months.
The UC Davis researchers say that creating corneal tissues may translate
into creating epithelial tissues for the bladder, intestine or lung.
1. Schwab IR, Reyes M, Isseroff RR. Successful
transplantation of bioengineered tissue replacements in patients with ocular
surface disease. Cornea 2000;19(4):421-26.
2. Tsai RJ, Li LM, Chen JK. Reconstruction of damaged
corneas by transplantation of autologous limbal epithelial cells. N Engl
J Med. 2000 Jul 13;343(2):86-93.
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Coroner Sued Over Corneas
John Murphy
Senior Editor
A coroner in Cincinnati authorized the harvesting of corneas from about
600 corpses without the permission of the families, the Associated Press
reports.
From 1985 to 1991, coroner Frank Cleveland allowed corneas to be taken
unless expressly denied by the deceased’s next of kin, AP reports. Mr.
Cleveland’s lawyers said he was following state law, but a federal appeals
court said that he violated federal law.
A Cincinnati widow sued the coroner after her husband’s corneas were
taken even though she did not grant permission. More than 500 other people
joined the widow to create a class-action lawsuit. The parties tentatively
agreed to a $5 million settlement.
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ISRS Defends Comanagement
“The Joint Position Paper on comanagement issued by the AAO [American Academy
of Ophthalmology] and ASCRS [American Society of Cataract and Refractive
Surgery] ... fails to recognize the critical role of patient choice in
the comanagement process,” says Jeffrey B. Robin, M.D., the executive vice
president of the International Society of Refractive Surgery.
At its annual symposium last month, the ISRS voted unanimously to develop
a comprehensive protocol for comanaging refractive surgery patients.
The AAO/ASCRS paper stated that the surgeon should provide pre- and
post-op care, except in limited circumstances, and that comanagement based
on future referrals or coercion by the referring doctor is “patently unethical
and, in many jurisdictions, illegal.”
While the ISRS expressed concern about comanagement relationships driven
by money, it says the AAO/ASRCS policies would prohibit the ethical and
legal comanagement arrangements between surgeons and other ophthalmologists
and optometrists.
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Bausch & Lomb Settles Solutions
Lawsuit
Bausch & Lomb has been selling eye care products under different names
but using the same formulas. Now the company will distribute 12 million
$1-coupons in its packages to settle a consumer lawsuit. (The company took
a $4.7 million charge against second-quarter earnings due to the settlement.)
B&L will also change the product labeling.
In 1995, two individuals sued on behalf of all consumers alleging B&L
did not disclose that some of its solutions and drops are identical to
others sold under different names for other uses and at lower prices. After
years of litigation in New York courts with no ruling, B&L decided
to settle rather than spend more time and money in court.
The company denies any wrongdoing, and has the FDA to back it up. One
of the FDA’s letters, submitted to the court, said, “FDA does not permit
saline, cleaning or conditioning solutions to be labeled as chemically
identical and/or interchangeable with rewetting drops.” The FDA lists these
reasons why:
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Lubricating and rewetting drops should not be sold in bottles larger than
30ml for ease-of-use and to avoid contamination.
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Misuse of cleaning and disinfection products results in inappropriate use
in the eye.
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Limiting a product to a single use—even when the formula is identical to
saline, cleaning or conditioning solution—enhances product safety and compliance.
B&L agreed not only to modify its labeling and include $1-off coupons,
but will write to eye doctors to explain the changes.
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Same B&L Formula, Different
B&L Name
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Same chemical formulation
Sensitive Eyes Saline Solution
Sensitive Eyes Drops
Eye Wash
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Same chemical formulation
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ReNu Lens Rewetting Drops
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Sensitive Eyes Saline/Cleaning Solution
Formerly same formulation; has since changed.
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Boston Original Conditioning Solution
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Boston Brand Rewetting Drops
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Artificial Retina Might Provide
Glimmer of Hope
Surgeons at the Chicago Medical Center at the University of Illinois have
implanted artificial retinas constructed of silicon chips in the eyes of
three patients with retinitis pigmentosa in the first phase of an FDA trial
of the device.
If all goes well, doctors may some day be able to offer patients a synthetic
option for restoring vision that doesn’t require an external power source
or the wearing of sensor glasses.
Optobionics Corporation of Wheaton, Ill., is developing the chip, called
the artificial silicon retina, or ASR. Alan Chow, M.D., and his brother
Vincent Chow, the company’s vice president of engineering, invented the
device.
The ASR, which is 2mm in diameter and 1/1,000 of an inch thick, is designed
to replace photoreceptors lost to RP. It’s equipped with 3,500 microscopic
solar cells that convert light into electrical impulses.
“What differentiates this from other implants is that it’s entirely
self-contained on the chip,” says David McComb, chief information officer
for Optobionics. “There are no external devices involved, such as prostheses
mounted on glasses. Also, it’s light powered, so it doesn’t draw on external
power.”
To implant the device, the surgeon first performs a vitrectomy, then
creates a small retinotomy. He then injects fluid into it to partially
detach the retina there, creating a subretinal pocket. Next, he inserts
the ASR with a special tool, then seals the retinotomy with air. The surgery
takes about 2 1/2 hours.
All three patients in the trial were discharged from the hospital the
following day. They’ve experienced no complications as of press time, and
the surgeons continue to observe them.
Says Mr. McComb: “The 2mm implants we’re inserting don’t necessarily
reflect what the final implant will be. Light perception is our first goal.
The next is motion, then, eventually, forms.”
The chips will probably have to be in for a month before the surgeons
can evaluate any visual results. For now, Chicago vitreoretinal surgeon
and ASR investigator Jose Pulido says, “We’re just waiting to see what
happens to these three patients at the moment.”
—Walt Bethke
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In the News
In late July, surgeons at the Sinskey Eye Institute, in Santa Monica, Calif.,
performed the first FDA-approved laser cataract removals. The cool beam
laser is said to be safer, less traumatic and allows for faster recovery
than phacoemulsification.
The Contact Lens Section of the AOA changed its name to the Contact
Lens and Cornea Section. “The name of the section should indicate the evolution
in our practices,” says section Chairman Roger F. Shaw, O.D.
Seeking a better foothold in the European ophthalmic market, Bausch
& Lomb is set to acquire Groupe Chauvin, a French pharmaceuticals company,
for about $228 million.
Jim Cox, a top executive at SOLA Optical USA, recently resigned to be
named president and CEO of Rodenstock North America. Mr. Cox’s exit from
SOLA took place in the wake of the departure of two other top SOLA executives.
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