In the wake of a voluntary global recall of its Complete Moisture Plus Multi-Purpose Solution, American Medical Optics (AMO; Santa Ana, California) said in a conference call yesterday morning that it would shift its focus to “rub” formulations of lens cleaners and hydrogen peroxide products.
“Rubbing promotes the most thorough level of lens cleaning and disinfection and is therefore in the best interest of all contact lens wearers,” James Mazzo, president/CEO of AMO said during the call. “The industry has grappled for years to balance efficacy, comfort and convenience.”
The company reported last week that it recalled its Complete Moisture Plus Multi-Purpose Solution as a precaution because of reports linking it to a rare, and serious, eye infection, acanthamoeba keratitis (AK), caused by a parasite. The link between the solution and the infection was identified as a result of an investigation by the Centers for Disease Control and Prevention (CDC; Atlanta) (Medical Device Daily, May 30, 2007).
Mazzo told conference call listeners that the AK issue affects the entire industry.
“Our expectation is that the AK issue will accelerate the pendulum-shift away from convenience and back toward efficacy,” Mazzo said. “We also expect to see a swing toward increased use of hydrogen peroxide solutions ... given that hydrogen peroxide solutions are most effective against AK, there may be a significant market opportunity here for our hydrogen peroxide products.”
The CDC has estimated that AK infections occur in around 2 out of every 1 million contact lens users in the U.S. annually. But it said that it performed a multi-state investigation of recent AK cases and determined that the risk of developing the infection was at least seven times greater for those consumers who used Complete MoisturePlus solution vs. those who did not.
The eye infection, caused by a waterborne organism, can lead to permanent vision loss or blindness, the CDC said.
Acanthamoeba is a microorganism commonly found in water, soil, sewage systems, cooling towers, and heating/ventilation/air conditioning systems. AK is usually found among individuals who improperly store/handle/disinfect their lenses (e.g., use tap water or homemade solutions for cleaning), swim/use hot tubs/shower while wearing lenses, come in contact with contaminated water, have minor damage to their corneas, or have previous corneal trauma.
“The bottom line at this point is that we still don’t know what caused the higher incidences of AK cases among the people that reported to the CDC that they used Moisture Plus at some point in the 30 days prior to their infection,” Mazzo said during the call. “The challenge here has been that there are a variety of potential factors relating to both the general increase in the number of AK cases as well as the apparently higher incidence of cases related to the use of Moisture Plus.”
Mazzo said AMO is looking at all potential factors that could account for the increase, including the company’s formulation, changes in contact lens material, environmental issues and the interaction between AMO’s formulation and “those other factors.”
Bear Stearns med-tech analyst Rick Wise wrote in a research report that though the CDC investigation remains ongoing with no cause yet determined, the focus on a “rub” solution suggests there could be a correlation between not rubbing lenses and recent eye infections, beyond just the specific solution used.
“Exploring our options for reentering the multi-purpose segment market we are working to meet what we anticipate will be a significant shift in consumer and regulatory demands for efficacy and we plan to help drive the shift by educating contact lens users on the importance of properly handling their lenses,” Mazzo said.
AMO did not provide sales or EPS guidance during the conference call as initially planned, because, Mazzo said, the company needs to “further analyze with respect to what our options are and what their financial impact might be.”
The good news, he added, is that these options will help AMO “get back into the game, perhaps quickly.”
CFO Randy Meier said that the company believes that every major retailer has received the appropriate instructions and the product is either gone from shelves or is in the process of being removed.