As a result of ReNu litigation exposure and a huge loss in sales due to the problems with ReNu, the contact-lens provider Bausch & Lomb Inc. has delayed the filing of its Q2-2006 financial report. B&L expects the recall of a lens solution will lower its full-year results for last year.

Bausch & Lomb Inc. revised its performance criteria in its 2006 incentive compensation plan to help motivate and retain key employees using sales and cash flow targets. The contact lens corporation said the move is designed to revitalize the company’s performance after its permanent withdrawal of the ReNu with MoistureLoc contact lens solution from markets in May 2006.

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Fungal eye infections caused by ReNu with MoistureLoc spread the globe as China gets ready to defend patients. http://news.xinhuanet.com/english/2006-06/28/content_4761334.htm

ReNu, a product by Bausch & Lomb, is responsible for rare eye infections known as fungal keratitis (Fusarium Keratitis). If untreated, these infections can cause blindess. Lawsuits for ReNu are being filed by a number of citizens of Asia who have suffered severe damage to their eyes as a result of using Bausch & Lomb’s ReNu.

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American law firms have announced that they have been retained by citizens of Asia who have suffered severe damage to their eyes as a result of using Bausch & Lomb’s ReNu with MoistureLoc contact lens solution. In February 2006, Bausch & Lomb ceased sales of all ReNu solutions in Singapore and Hong Kong after many users of ReNu with MoistureLoc were diagnosed with fusarium keratitis. http://www.primezone.com/newsroom/news.html?d=102549

Lucky for ReNu users, a team of Singapore healthcare professionals were the first to alert the world on a link between a ReNu contact lens solution and a global spike in fungal corneal infections, according to the Singapore News.
In singapore, Health Minister Khaw Boon Wan said: “Certainly when you decide to do something like this, you’re taking on a very big multi-national corporation and as I said, they’re armed with teams of (scientists and) lawyers. And if the advisory was pre-mature or without basis, or could not be proven, I’m quite sure there’ll be a legal suit on our table.
“But more than legal suits, it’s also our own reputation. In this instance, the reputation of SNEC and of course Ministry of Health and Singapore. So I’m quite glad. More importantly it ended up well.”
All ReNu users owe thanks to these courageous doctors for stepping forward and alerting the world of this public health risk.

Hao Junbo, the group’s lawyer, told China Daily yesterday that less than 10 people had so far provided sufficient evidence to back up the claims. “I’ve sent full medical documents of three infections to my partner in the United States,” he said yesterday. China Daily July 11, 2006
This represents a whole new front which Baushc & Lomb will have to defend itself. It is fitting that this litigation be brought, since it is the Asian consumers who first reported the problems of eye infections to Bausch & Lomb.

Clusters of Fusarium keratitis were reported among contact lens users in Asia beginning in November 2005. See http://www.aoa.org/x5161.xml. In February 2006, Bausch & Lomb voluntarily suspended sales of its ReNu multipurpose solutions both in Singapore and Hong Kong. On March 8, 2006, The Centers for Disease Control and Prevention (“CDC”) received a report from an ophthalmologist in New Jersey concerning a cluster of three patients with contact lens-associated Fusarium keratitis during the preceding 3 months. Source American Optometric Association. See http://www.aoa.org/x5159.xml.
As of April 9, 2006, a total of 109 patients with suspected Fusarium keratitis were under investigation in 17 different states in the United States. See http://www.cdc.gov/mmwr/preview/mmwrhtml/mm55d410a1.htm. Prior to this problem, fungal keratitis had been rarely reported in the healthy soft contact lens wearing population. Historically, the vast majority of contact lens related microbial keratitis has been caused by bacterial pathogens such as Pseudomonas aeruginosa. See http://www.aoa.org/x5166.xml. The FDA News, P06-56 explained, “organisms associated with contact lens-related keratitis are usually bacteria rather than fungus, often arising from contamination of lens care products or from contact lens storage cases.”

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Fungal keratitis is an extremely serious eye infection that can develop through the whole depth of the cornea. The infection can require prolonged drug therapy with antifungals such as natamycin or nystatin. If drugs do not work and the eye is damaged, surgery may be necessary to remove fungal ulcers and/or lesions, or to implant a shell to preserve the shape and structure of the eye. Symptoms of fungal keratitis include: sudden blurry vision, unusual redness of the eye, pain in the eye, excessive tearing or discharge from the eye, and increased light sensitivity. Source: American Academy of Ophthalmology. These infections are usually very difficult to treat and may result in severe visual loss or even loss of the eye. Many victims are required to undergo a corneal transplant to prevent the fungus, which is very aggressive, from reaching the back of the eye. Additionally, a very large percentage of corneal transplants are rejected, requiring the victim to undergo a second surgery.
Alexidine is a disinfectant that traditionally has been used in mouthwash solutions. Its first use in contact lens solutions was in ReNu with MoistureLoc, thus it is a “new” product in this arena. It is believed that Alexidine is the cause or is a partial cause of the problems with this product. The current theory is that ReNu with MoistureLoc does not have sufficient disinfectant efficacy — though it is currently unknown whether it starts out with insufficient efficacy or loses efficacy over time sitting on the shelf — to fight the Fusarium fungus, which is very common.
Tomorrow: Cases of Fusarium keratitis associated with ReNu with MoistureLoc

ReNu with MoistureLoc first became commercially available in the United States in 2004. It is a daily use contact lens solution that according to the package insert is used in “the daily cleaning, removal of protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses.” Users are directed to soak their contact lenses in ReNu with MoistureLoc for “at least four (4) hours.” When used daily ReNu with MoistureLoc Multi-Purpose Solution “cleans, loosens, and removes accumulations of film, debris and deposits from soft contact lenses. [It] helps prevent the formation of irritating deposits on the lens surface. It kills harmful microorganisms on the lens. While your lens is soaking, the formula surrounds the lens with a moisture attracting matrix.”
According to the packaging, the product has been specifically formulated with “MoistureLoc technology, to work in harmony with your tears to provide sustained comfort and clean lenses day after day. When used daily, this unique combination of ingredients fights dryness by surrounding the lens with a long lasting cushion of moisture.” It is also claimed that those contact lens wearers with non-Sjorgen dryness may experience improve comfort compared to their previous lens care system by using ReNu with MoistureLoc.
Tomorrow: Fungal Keratitis