CRSToday Europe News — May 2008

New Antibiotic Class Shows In Vitro Activity Against MRSA
A novel antibacterial protein showed rapid antibacterial activity against clinical isolates of methicillin-resistant Staphylococcus aureus (MRSA), according to a poster presented at the European Conference on Clinical Microbiology and Infectious Diseases. PT1.2, a vector for delivery of an S. aureus-specific small acid-soluble spore protein (SASP), was tested against 10 MRSA isolates collected in the United States. SASPs are a new class of antibacterial protein that bind to bacterial DNA and halt replication and gene expression, resulting in rapid cell death, according to Phico Therapeutics (Cambridge, UK), the developer of PT1.2. These results could lead to a breakthrough in the fight against hospital- and community-acquired infection, according to Phico Therapeutics Chief Executive Officer (CEO), Heather Fairhead. "The study, carried out in conjunction with the UK's Health Protection Agency, showed that SASP was rapidly bactericidal against all 10 different MRSA isolates gathered from across the United States," she said.

In the speed-of-kill assay, SASP decreases of more than 99.9% in viability within 5 minutes in a MSRA isolate diluted to 5 x 105 cfu/mL and within 10 minutes in an isolate diluted to 5 x 107 cfu/mL, according to the poster authors.

Cost Varies in European Cataract Surgeries
The cost of cataract surgery can vary by as much as a factor of three across European countries, according to an Italian study appearing in the journal Health Economics.

The study, examining health care costs, found that cataract surgery could cost patients more than €1,000 (Italy) and a little as €318 (Hungary).

David Allamby, MD, Medical Director of a laser vision clinic in London, said that price difference may also vary from clinic to clinic. "The difference in surgery prices is truly astonishing," Dr. Allamby said in a written statement. "I feel sorry for patients looking into having their eyes corrected …[who might] pay thousands of pounds more than one clinic versus another."

The cataract surgery price study was part of a larger research project in the European Union called HealthBASKET, which examined the prices of various surgeries in Hungary, Poland, the Netherlands, Denmark, Spain, England, Germany, France, and Italy.

The study's authors concluded that clinics could streamline their efficiency by using other countries' models for comparison. This "is very important for activating benchmarking exercises and promoting efficiency," they wrote. "The availability of cost information about providers across Europe…[may promote] the transferability of good-practice solutions."

The authors also found a modest variation in the cost of an IOL among the six countries, with the Netherlands showing an average cost of €106 and Spain at €217.

Additional factors for cost included patient management (eg, time spent on each patient), the use of foldable IOLs, and labor costs. "On average, each day of hospital stay increased total costs for the cataract intervention by 62%," the authors wrote.

Examining the numbers and determining where the differences lie will help health care organizations evaluate their performance, the study's authors concluded.

US FDA Holds Hearing on Quality of Life After LASIK
The US Food and Drug Administration (FDA) will begin a study to examine post-LASIK quality-of-life issues, after comments at a public FDA hearing raised questions about the impact the surgery may have on patients.

More than a dozen people testified that LASIK surgery caused injury or psychological problems, such as severe depression and, in at least one case, suicide. They urged a moratorium on the procedure until more studies could determine its safety.

The FDA panel concluded that although there is a need to further alert consumers to the possibility of dry eye, poor visual outcomes and other complications, as well as to study quality-of-life issues connected to the procedure, there would not be a moratorium on LASIK.

A LASIK joint task force, headed by the FDA and members of the American Society of Cataract and Refractive Surgery (ASCRS), the American Academy of Ophthalmology (AAO), and the National Eye Institute will begin studying factors that cause patients to be dissatisfied with their outcomes. Still in the preliminary stages, the $1.2 million quality-of-life study will start by 2009, according to Daniel Schultz, head of the FDA's medical devices center.

Bausch & Lomb Launched Multimedia Center for Stellaris
A new Multimedia Center (MMC) is now available as an add-on for the Stellaris Vision Enhancement System (Bausch & Lomb, Rochester, New York). The MMC allows surgeons and operating room staff to collaborate and improve productivity by providing an enhanced view of the surgery, according to the company. Previously, the OR assistant would look at both a graphic user interface (GUI) and a separate monitor during the surgery. The launch of the Stellaris MMC makes it possible to have both views on the same 18-inch, high-definition touch display. This display or GUI includes "intuitive function icons and controls located in fixed positions to facilitate user orientation" and an on-screen video help system leading to rapid learning, according to Bausch & Lomb.

British Doctors Show Little Confidence in NHS Database
Nine out of 10 doctors have no confidence in the government's ability to safeguard patient data online, according to a poll conducted by the British Medical Association (BMA). The poll also revealed that "more than 90% of survey respondents said they were not confident patient data on the proposed NHS centralized database would be secure," the organization said.

Nine out of 10 ten doctors, of the 219 doctors who responded to the poll, also said they did not feel they were in a position to assure patients that their data would be safe, the BMA said in a news release.

Tetraflex Provided Good Near, Distance Vision at 6 Months
The Tetraflex accommodating IOL (Lenstec, Inc., Saint Petersburg, Florida) provided enhanced near vision and good distance vision up to 6 months postoperatively, according to a recent study.

The study, published in Ophthalmology, also found that almost 100% of 95 patients had at least 1.00 D of accommodative amplitude at 3, 6, and 12 months follow-up; 75.7% of patients had at least 2.00 D at 1 year follow-up; and 96% had at least 2.00 D at 1 year after bilaterial IOL implantation.

"With its minimal learning curve, I am happy to let my residents implant this lens," said Sunil Shah, FRCOopth, FRCS(Ed), Medical Director, Midland Eye Institute, Solihull, UK. "I have had very good results with no halos, glare, or night vision problems. Additionally reading speeds are better than would be expected on other global measures, like the amount of accommodative ability on push-pull tests," he added.

The Tetraflex accommodating IOL currently accounts for more than 30% of the presbyopic IOL market in Europe, according the company.

The lens is made of an advanced polyHEMA material that allows the lens to flex while positioned in the eye, allowing patients to regain the ability for near, intermediate, distance vision.

Novartis to Acquire Stake in Alcon; Further Buys Possible
Following an announcement that Novartis International AG (Basel, Switzerland) intends to purchase 74 million shares of Alcon, Inc. (Huenenberg, Switzerland), common stock from Nestlé (Vevey, Switzerland), Novartis Chief Executive Daniel Vasella announced that the company could make more acquisitions in the future.

"One can assume that we will not do an acquisition on this scale and not in this area," Mr. Vasella said in an interview with a Swiss newspaper. "Medium-sized acquisitions … would certainly be possible." However, no specific acquisitions are planned at the moment, he added.

If approved, the Alcon transaction will give Novartis approximately a 25% minority stake in the company. The deal stipulates that Nestlé will retain approximately 52% of Alcon's outstanding shares and remain the company's majority shareholder. Novartis will have the option to buy Nestlé's remaining shares of Alcon at a fixed price of $181 per share from January 1, 2010, to July 31, 2011. Nestlé will also have the option to sell its remaining stake in Alcon either at that fixed price or a 20.5% premium above the market price of the shares for the preceding week on its option, whichever is lower, according to the announcement.

Additionally, the agreement calls for the expansion of Alcon's board of directors from eight to 10 members, with one additional member chosen by Nestlé and one by Novartis. The agreement is subject to regulatory approvals.

Older Corneas Still Suitablefor Transplantation
The age pool of corneas suitable for transplant should be expanded to include donors up to 75 years old, according to a study published in Ophthalmology.

"The majority of donors have been older, but there has been a great prejudice against using older tissue for fear that it was going to wear out faster," said Dwight Cavanagh, MD, PhD, the study's principal investigator. Because of that, many doctors declined to use tissue from older donors, he added.

The study examined 1,090 patients undergoing corneal transplantation for a moderate-risk condition (ie, Fuchs dystrophy, pseudophakic corneal edema) and included 5 years of follow-up. Forty-three participating eye banks provided corneas from donors ranging in age from 12 to 75 years, with endothelial cell densities of 2,300 to 3,300 cells/mm2. The 5-year cumulative probability of graft survival was 86% in both the first (aged 66 years or younger) and second donor groups (aged 66 years or older).

Researchers also found that the distributions of the causes of graft failure did not differ between donor age groups.

"The data are convincing," Dr. Cavanagh said in a news release. "There is not a difference between old and young tissue. What matters is how many cells are alive in the tissue regardless of the age of the donor. And there are plenty of people of older age who have high cell counts," he said.

Presbyopia Decreased Quality of Life
Patients experience a nominal decrease in their quality of life with spectacle-corrected presbyopia, according to a study published in the American Journal of Ophthalmology. The change is similar to that of a patient with treated hypertension, the study's authors wrote.

For the cross-sectional analysis based on patients' preferences, investigators interviewed 110 patients with spectacle-corrected presbyopia and a BCVA of 20/40 or better.

A utility analysis was used to objectively measure the quality of life associated with the health state of the patients involved in the study.

Patients were asked to decide how valuable they would consider a technology that would improve their vision but decrease their lifespan.

Among the overall cohort, 11 patients (10%) were willing to trade at least 5% of their remaining time of life to be rid of their presbyopia. Six patients (5.5%) were willing to trade a minimum of 10% of their remaining time of life to be rid of presbyopia, according to the study.

"In summary, the health state of presbyopia is associated with a mild decrease in quality of life for the average person with the condition," the study's authors wrote. "Higher degrees of presbyopia seem to cause the same quality of life diminution as milder forms."

Still, the researchers wrote, "we suspect, from the results of this series, that the 10% of presbyopes willing to trade at least 5% of their remaining time of life to be rid of presbyopia may be candidates for an intervention to correct the condition."

Anesthetics Compared in Cataract Surgery
Topical anesthesia with levobupivacaine 0.75% and ropivacaine 1% were safe and more effective than lidocaine 2% in cataract surgery, according to a study published in Eye.

The comparative clinical trial examined 105 patients scheduled for cataract surgery using one of three anesthetics (35 patients per group). Patients graded their pain on a scale of one to 10 at different stages throughout the procedure.

According to the researchers, there was no significant difference in the duration of surgery and demographic variables among the groups. During the intraoperative period, at the end of the surgery, and the first hour postoperatively, however, the mean verbal pain score was significantly higher in the lidocaine group. Researchers also found that surgeon and patient satisfaction scores were significantly better in the levobupivacaine and ropivacaine groups compared with the lidocaine group. Pain levels at the time of incision and 24 hours postoperatively were not significantly different in any group.

"Levobupivacaine and ropivacaine provided significant and long-lasting analgesia without the need of supplemental anesthesia for each patient," according to M. Borazana, of Turkey, and colleagues.

– Compiled by Leah D. Farr, News and Industry Editor