Medical Device Daily Associate

Cornea specialists at Bascom Palmer Eye Institute (Miami) of the University of Miami's Miller School of Medicine said they have documented an increased incidence of an aggressive form of fungal corneal infection apparently related to soft contact lens use.

Eduardo Alfonso, MD, professor of ophthalmology, and Edward Norton, MD, chair in ophthalmology, confirmed an “unusually large number“ of patients with fusarium keratitis, a sight-threatening corneal infection normally associated with eye trauma involving fungus from plant or vegetable matter or soil.

“This is quickly becoming a cause for alarm,“ said Alfonso, cornea and external disease specialist and medical director of Bascom Palmer's microbiology lab. “We have mobilized cornea specialists throughout the world to hasten our understanding of the spread of this particular type of fungus and have learned of a sudden increase in the number of cases in the U.S., Singapore, Malaysia and Australia.“

The incidence of fungal corneal infections is unprecedented as most corneal infections related to contact lens use had previously been bacterial in nature, which is significantly less complicated to treat than fungal infections.

Soft contact lens use has been the only identified risk factor in the majority of the cases seen between January and March 2006 at the institute's Miami facility, where it said 21 cases have been identified, 12 among contact lens users.

Between 2000 and 2005, the average number of fusarium keratitis cases was 21 per year. Usually, less than 2% of these cases have been in contact lens users, the institute said.

“Keratitis“ – also known as a corneal ulcer – defines a variety of infections, irritations and inflammations of the cornea. “The delay in proper treatment for fusarium keratitis may make it more difficult to treat later on,“ added Alfonso. Treatment may include anti-fungal medication.

Some patients with this fungal infection have experienced a significant loss of vision, resulting in the need for a corneal transplant.

Bausch & Lomb (B&L; Rochester, New York) reported late last week that it is working with global health authorities to determine the cause of the increase in the fungus infection, noting that problem first surfaced in parts of Asia (Medical Device Daily, March 27, 2006). It said it is cooperating with investigations of the infections by the Centers for Disease Control and Prevention and health ministries in Singapore, Hong Kong and Malaysia, as well as Bascom Palmer and the Johns Hopkins Wilmer Eye Institute (Baltimore).

In a press release, the company said it believes that the cause of the fungus infections is not related to any specific contact lens or lens-care product.

Authorities in Singapore linked a number of cases of the infection to use of B&L ReNu contact lens solution, but authorities there are not saying it was the direct cause. Hong Kong asked B&L to pull ReNu from shelves, but testing has not shown a problem.

The company said tests of the products yielded no evidence that they in any way caused or contributed to the infections.

The company also noted that many of the reported cases in Asia involved examples of poor patient compliance with lens care and contact lens wear, including wearing expired lenses and re-using daily disposable contact lenses. It urged contact lens wearers to follow good hygiene and proper lens care practices to prevent infection and warned against the use of unregulated “knock-offs.“

The company said the situation is expected to reduce its first-quarter vision care revenues in Asia by as much as $10 million vs. internal expectations.

Hong Kong and Singapore are relatively small markets, but the publicity associated with the unusual incidence has spread beyond their borders, the company said, depressing sales in other areas, particularly China, which is being impacted. This, though there have been no reports of fusarium keratitis infections among contact lens wearers there.

Jason Mills, analyst for First Albany Capital (New York), wrote in a research report that he expects ReNu to be vindicated. He said it will require “incremental spending to recoup 'brand image' in Asia,“ though B&L will “fully recover.“

Analyst Joanne Wuensch of medical investment banking firm Harris Nesbitt (New York) wrote in a report that B&L's problems, coupled with manufacturing quality problems at optical powerhouse CIBA Vision (Duluth, Georgia) this quarter, could benefit the lens care franchises of Alcon (Fort Worth, Texas) and Advanced Medical Optics (Santa Ana, California), at least temporarily.

AHRQ to meet on Friday

The National Advisory Council for Healthcare Research and Quality (AHRQ; Washington) will meet on Friday from 9 a.m. to 3 p.m. The council provides advice to the Secretary of Health and Human Services and the Director of the Agency for Healthcare Research and Quality on matters related to AHRQ's customers and health services researchers.

The meeting, which is open to the public, will begin with an update on the status of AHRQ's current research, programs, and initiatives.

The council also will discuss AHRQ's Effective Health Care Program, ambulatory care safety, and engaging consumers in quality and safety. For details, visit AHRQ's web site at