CDC: No Links To Other Products In Latest Eye Infection Data

Source | DOW JONES NEWSWIRES

The U.S. Centers for Disease Control and Prevention’s probe of an eye infection that knocked an Advanced Medical Optics Inc. (EYE) contact lens solution from store shelves in May has expanded to include more than 100 studied patients, and has not shown links to any other products, a CDC official said late Wednesday.

The latest data continues to show a link between the cases of “Acanthamoeba keratitis” and Advanced Medical’s Complete MoisturePlus product, however. When the CDC announced preliminary data in late May, the agency had assessed 46 people with confirmed cases of the eye infection. The agency has now ramped up to 102 interviewed patients, and Complete MoisturePlus remains the only lens solution seen as an issue.

“That is the only solution that comes up significant,” said Michael Beach, an epidemiologist with the CDC, and part of the team investigating the outbreak of Acanthamoeba infections, in an interview with Dow Jones Newswires.

The lack of further product connections is positive for Advanced Medical’s lens-solutions competitors, including Bausch & Lomb Inc. (BOL), Alcon Inc. (ACL) and Novartis AG (NVS) unit Ciba Vision.

The CDC does not plan to interview more patients beyond the 102 interviewed thus far, which means that if other infection risk factors do show up in the ongoing research, they’re more likely to involve issues such as lens-care habits rather than notices of product troubles, Beach said.

The CDC went public with preliminary findings in May because it wanted to warn people of issues with Complete MoisturePlus.

“The positive thing from my standpoint is the main public health intervention has been done,” Beach said.

Later findings may simply reinforce what the agency already recommends in terms of proper lens care and handling to ward off infections. Acanthamoeba is a common bug, though eye infections are rare, and eye doctors have been stressing that contact lens wearers need to practice better hygiene to defend themselves. Acanthamoeba infections can be devastating, potentially leading to blindness, and very tough to fight.

The CDC data so far have not indicated that water quality standards are behind increased infections, as hypothesized by researchers at the University of Illinois at Chicago, which has investigated local infections and brought the issue of increased infection cases to the CDC’s attention last year. The CDC also hasn’t seen silicone hydrogel, a material used in the most popular type of contacts on the market, show up as a risk factor thus far, Beach said.

The water and silicone hydrogel questions will be studied further with a new batch of “controls”, or healthy lens wearers who live near and are similar to infected people, that the CDC has been collecting for comparisons in its research, Beach said. The agency has found it harder than expected to collect controls and is cutting off the search now so that it can move on with its analysis.

A final report including a comparison to controls and a deeper look at risk factors is likely to be available in the next couple of months, Beach said. The number of infected patients studied in the final report is likely to fall below 102 due to the difficulty of finding matching control subjects.

The CDC initially matched up people with Acanthamoeba infections to controls collected during a different eye infection probe last year. The early data showed that people with soft contact lenses who had an infection were at least seven times more likely to have used Complete MoisturePlus, compared with healthy lens wearers.

Things haven’t changed much now that the number of infected people investigated has more than doubled, Beach said.

“We continued enrolling cases, and when you look at more cases, the same trend is there” in terms of the Complete MoisturePlus connection, he said. The agency still doesn’t believe there’s a product contamination issue with the Advanced Medical product, he added.

The infection probe last year involved a fungal infection that was linked to Bausch & Lomb’s ReNu with MoistureLoc lens solution, which was pulled from the market. Advanced Medical made an offer last week to buy Bausch & Lomb for $45 in cash and $30 in stock, competing with a $65-per-share offer from private-equity firm Warburg Pincus. A major Advanced Medical shareholder has gone public with concerns about the bid and plans to vote against a deal.

Advanced Medical hopes to bring an older multipurpose lens solution product to store shelves by the end of the third quarter.