August 2000 News Review

Optometry Mourns Loss of Dr. Rodger Kame
Lab-Grown Corneal Grafts for Extreme Cases Only?
Sidebar: Coroner Sued Over Corneas
ISRS Defends Comanagement
Bausch & Lomb Settles Solutions Lawsuit 
Table: Same B&L Formula, Different B&L Name 
Artificial Retina Might Provide Glimmer of Hope
Stuff You Can't Get in Print: In the News

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:

  • Lubricating and rewetting drops should not be sold in bottles larger than 30ml for ease-of-use and to avoid contamination.
  • Misuse of cleaning and disinfection products results in inappropriate use in the eye.
  • 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 

Same chemical formulation
  • Sensitive Eyes Saline Solution
  • Sensitive Eyes Drops
  • Eye Wash
  • Same chemical formulation
    • ReNu Lens Rewetting Drops 
    • Sensitive Eyes Saline/Cleaning Solution
    Formerly same formulation; has since changed.
    • Boston Original Conditioning Solution 
    • 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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    © Review of Optometry OnLine
    August 15, 2000
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