Dow Jones Newswires | Three years after pulling a contact-lens
solution from the $1.7 billion global market because it was linked to
damaging eye infections, and then relying on an older version, Abbott
Laboratories’ (ABT) eye-care unit is launching something new.
Called RevitaLens, the multipurpose lens solution for cleaning and
storing lenses gained approval from European regulators in late May.
Abbott is launching the product in select overseas markets this month,
and more fully by year end. Meantime, it hopes for approval from the
U.S. Food and Drug Administration in the second half of this year.
It will have some fresh competition, as Bausch & Lomb has put a new multipurpose solution called Biotrue on U.S. shelves at Kroger and Target, and is planning an official announcement at an upcoming conference.
Abbott bought Advanced Medical Optics for $1.36 billion early last year and has rebranded it Abbott Medical Optics. The company makes equipment used in laser vision-correcting eye surgery, along with lens solutions and cataract treatments.
In mid-2007, Advanced Medical permanently recalled a multipurpose solution called Complete MoisturePlus after health authorities found a connection between it and a rare but serious infection called Acanthamoeba keratitis.
The company was working on a follow-up lens solution that, before the recall, it expected to introduce by early 2008. But Advanced Medical ended up putting that product on the back burner while it dealt with the recall, and the company re-released an older Complete-brand solution that is still on pharmacy shelves.
“This has taken some time to develop,” spokesman Steve Chesterman said, regarding RevitaLens. Beefed-up FDA guidelines plus internal requirements for new solutions stretched the development time, he said.
The FDA’s requirements for new solutions are still a work in progress, after the MoisturePlus recall and the 2006 recall of a Bausch & Lomb solution due to a different infection. But it’s likely any new products will have to better prove they fend off such bugs.
According to Abbott, RevitaLens kills both Acanthamoeba and Fusarium, the bug that felled the Bausch & Lomb product. And, since lab tests may not replicate the bad lens-care habits that can compromise disinfectants, “it has been tested against certain consumer-abuse conditions,” Chesterman said.
Bausch & Lomb also highlights that its newest solution works against the problem bugs.
Abbott recommends a rub-and-rinse regimen for cleaning lenses with its new product, which Advance Medical reverted to after the recall. Before that, major multipurpose solutions broadly advertised “no rub” claims backed by the FDA, but not popular among eye doctors who felt the extra cleaning step was a helpful hedge against infections. Some products still highlight “no rub” options.
The global market for just multipurpose solutions is worth about $1 billion. Abbott estimates it has low double-digit global share in this market, which compares with the mid to upper teens before the 2007 recall. Alcon Inc. (ACL) is the market leader, and other manufacturers include Bausch & Lomb, which is owned by investment firm Warburg Pincus LLC, and Novartis AG (NVS) unit Ciba Vision.
Novartis partially owns Alcon and aims to buy the rest, but has been criticized for its offer to minority shareholders. Contact lens maker Johnson & Johnson (JNJ) has indicated it wants to sell lens solutions but hasn’t estimated when that could happen.
