Abbott Medical Optics Inc. has received the regulatory go-ahead for a new use of a core product.
The Santa Ana-based unit of diversified drug and device maker Abbott Laboratories recently got Food and Drug Administration clearance to use its iFS Advanced Femtosecond Laser device for what are called arcuate—or bow-shaped incisions—in corneal procedures, including cataract surgery.
The approval for use of the device on cataracts gives Abbott Medical footing in a market estimated at about 3 million patients a year.
The iFS laser is now primarily used for incisions that create flaps for lasik vision correction, along with some other procedures, most of which are elective and not covered by healthcare insurance. It is in its fifth generation and has been used in more than 5 million surgeries worldwide.
Abbott Medical primarily competes with Switzerland-based Alcon Laboratories Inc., which has more than 800 Orange County workers, in the eye laser devices.
Cataract procedures are generally covered by insurance plans, including Medicare.
Abbott Park, Ill.-based Abbott Laboratories got the iFS laser as part of its $2.8 billion acquisition of Advanced Medical Optics Inc. in 2009. Advanced Medical acquired the device in 2007, when it bought Irvine startup IntraLase Inc. for $808 million. Advanced Medical was spun out nearly 10 years ago from Irvine drug maker Allergan Inc.
Abbott Medical President James Mazzo, who’s also a senior vice president for parent Abbott Laboratories, called the regulatory approval “a major advancement and expansion” of femtosecond lasers.
“This is an important step as we look to (use) femtosecond laser technology as a potential standard of care during the cataract procedure,” he said.
Billing
There also have been cautious reactions on the billing for laser-assisted cataract surgery.
The American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology in February handed down billing guidelines for doctors after talking with the Centers for Medicare & Medicaid Services and others.
The guidelines seek to establish a standard that discourages doctors from billing Medicare more for laser-assisted surgeries compared with procedures using a surgical knife. The guidelines also advise doctors not to ask Medicare patients to make up the difference.
Dave Harmon, president of St. Louis-based Market Scope LLC, an ophthalmology industry research firm, recently told the Business Journal that adopting the use of lasers in cataract surgeries could be appealing for doctors because the average cost of the devices is about $400,000.
But doctors have “to be really careful with the economics” of lasers because they can only charge certain rates for cataract surgeries under Medicare, Harmon said.
Cataract surgery is Abbott Laboratories’ “largest, most profitable and fastest-growing segment” within its vision care unit, which includes Abbott Medical, said John Thomas, the parent company’s vice president of investor relations, on Abbott’s first-quarter conference call earlier this month.
Abbott Medical counted sales of $272 million in the first quarter, up 1.5% from last year’s second quarter.
Abbott said that using the iFS laser would allow eye surgeons the ability to make incisions with greater precision, predictability and customization than is possible with a traditional incision by a surgical knife.
Pipeline
The iFS cataract clearance is one of several new products or line extensions that are gearing up to be introduced by Abbott Medical either in the U.S. or overseas.
“This year alone, [we’ll] introduce eight new products—these are eight new developments. I don’t remember eight new products ever coming out in one year in AMO’s history,” Mazzo said earlier.
Other products on tap include two entries from Abbott Medical’s Tecnis intraocular replacement lens product line. One is a toric multifocal lens, which corrects astigmatism. That lens will be first introduced in Europe, with FDA approval for U.S. sales pending.
Abbott Medical is also gearing up to market another Tecnis lens in a preloaded injector for Europe and Canada, with expected U.S. introduction next year.
The company has also developed a lower-cost intraocular lens called Sensar-1 that’s aimed at India and other emerging markets.
Abbott Medical is now learning to “design products by certain geographies,” Mazzo said.
In the laser market, Abbott Medical is planning to introduce iDesign, an eye diagnostic device, in Europe and Japan.
It’s also awaiting word from the FDA on Healon EndoCoat, which Mazzo called a “dispersive viscoelastic.” Doctors use viscoelastics to protect the eye during cataract surgery.
