Following the May 25 voluntary global recall of its primary product (Complete MoisturePlus, Advanced Medical Optics Inc. (AMO) has begun shipping an existing formulation of its multipurpose contact lens cleaning solution (Complete) to markets in the United States and Europe. (See Ophthalmology Times, June 15, 2007.) Shipments to Japan and the rest of the Asia-Pacific region are expected to begin before the end of the third quarter, and the company said it expects to be in all markets by the beginning of the fourth quarter.
Shipments to Japan and the rest of the Asia-Pacific region are expected to begin before the end of the third quarter, and the company said it expects to be in all markets by the beginning of the fourth quarter.
"We accomplished this [re-entrance] in less than 90 days, ahead of our original time frame," said Randy Meier, AMO chief financial officer, chief operating officer, and head of the eye-care division, in an Aug. 2 conference call with investment analysts. The company previously said it hoped to return to the multipurpose lens solution market by late September.
The recall reduced eye-care product sales for the company by approximately $54 million, including approximately $31 million in returns and an estimated $23 million in lost sales, according to AMO estimates. As a result of the sales returns, the company reported negative multipurpose lens-care sales of $7.8 million. Recall-related costs amounted to about $27 million, according to second-quarter earnings reports filed with the Securities & Exchange Commission.
Following the recall of the multipurpose contact lens solution and an apparent association with an outbreak of Acanthamoeba keratitis cases among contact lens wearers who used the solution, AMO officials said they would move away from "no rub" claims. Research by the company and the Centers for Disease Control and Prevention showed that the rise in eye infections coincided with the launch of AMO's solution, Meier said. However, that link was not found with any other formulations from AMO, and the company said it worked closely with the FDA to introduce a product free of potential problems.
"We felt, in discussions with the FDA, that some of the ingredients we have added over the past couple of years- predominantly the comfort agent-created, in their opinion, some formulation stressors. We have taken those out in generating this formulation," Meier said. "This formulation has been in market since 2002, it has a strong safety record, and [it] was not implicated at all with the Acanthamoeba keratitis research done by CDC. This product has been fully endorsed by FDA in terms of the relaunch."
The product's packaging bears the name Complete, along with a different design and label from the previous version. The label includes a recommendation for contact lens wearers to rub and rinse their lenses when cleaning them, a practice advised by 74% of practitioners and most eye-care specialty organizations, Meier said. (See Ophthalmology Times, July 1, 2007.)
With this relaunch, AMO hopes to return to market shares of 16% to 18% globally by the end of 2008-a level equal to early 2006, Meier said.
Although the second quarter saw a 15% drop in sales of hydrogen peroxide-based lens cleaning solutions, the company anticipates sales may rise in light of the outbreak of Acanthamoeba keratitis and called hydrogen peroxide systems "the cornerstone of any regimen."