Abbott gets EU go-ahead for implant in aging eyes

Abbott's Tecnis one-piece lense--Courtesy of Abbott Medical Options

Cataracts are big business for Abbott ($ABT). It's ready to roll out the latest in its line of implantable Tecnis lenses in Europe after recently receiving a CE Mark for the product, which will be used to treat cataract patients who may also have a diminished ability, due to aging, to focus on near objects (presbyopia).

There is no FDA-approved implantable device to treat presbyopia, but a slew of start-ups are working on presbyopia implants. These include AcuFocus, whose Kamra in-lay for presbyopic patients recently won a cautious nod from an FDA panel, as well as startup PowerVision, which recently garnered a $30 million venture round, and ReVision Optics, a Johnson & Johnson-backed company ($JNJ) that scored a $55 million investment last year.

The Tecnis Symfony Extended Range of Vision intraocular lens that recently received the CE Mark is the first presbyopia-correcting, extended range-of-vision intraocular lens, according to Abbott.

Abbott had $1.1 billion in vision care sales in 2013, with sales for all medical devices totaling $5.5 billion. At the recent William Blair conference, CFO and EVP of Abbott, Thomas Freyman said vision care sales have been growing "at a double-digit pace in recent quarters, driven by accelerating growth in our cataract lens business."

Cataract lenses account for more than 65% of vision care sales for Abbott. Freyman also noted that Abbott holds the number two in the cataract lens market, where it's been gaining market share. Novartis' ($NVS) Alcon division is first in the implantable cataract lens market with 2013 sales of $1.3 billion. Vision specialist Alcon had $10.5 billion in total net sales last year, all of which was related to eyesight.

Last year, Abbott won regulatory approval for its Tecnis Toric monofocal intraocular lens to treat cataract patients with preexisting corneal astigmatism in the U.S., China and Japan. It also markets other Tecnis cataract lenses.

Cataract surgery is the most common surgical procedure, according to Abbott. There were 3.5 million cataract surgeries in Europe last year. The World Health Organization has set a target of 32 million as the annual number of cataract surgeries globally by 2020.

Abbott has started a 150-patient European study to evaluate the quality of vision at intermediate and near distances when Tecnis Symfony is implanted in both eyes. The study will also assess patient and surgeon satisfaction, results are expected later this year. The company is also conducting a post-marketing observational study of about 400 European patients, also with data anticipated by year-end.

- here is the press release