Alcon bags CE mark for preloaded intraocular lens delivery system

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Alcon scored a CE mark for its Clareon intraocular lens in May and hopes to gain FDA approval for the device next year.

Novartis’ Alcon earned a CE mark for its automated, disposable, preloaded intraocular lens delivery system. The company is introducing the device, dubbed AutonoMe, alongside its next-gen Clareon intraocular lens (IOL).

The AutonoMe device uses a carbon dioxide-powered delivery mechanism to insert an IOL during cataract surgery, Alcon said in a statement.

"Comfort and efficiency during the cataract surgery are key to achieving better outcomes. This new device is expected to improve the procedure and ultimately to reduce surgical time," said Rudolph Nuijts of University of Maastricht in the Netherlands in the statement.

Alcon will debut the AutonoMe device and the Clareon IOL at the European Society of Cataract and Refractive Surgeons Congress next week. The company expects to roll out the product duo in the EU in early 2018. Novartis aims to get Clareon past the FDA in 2019.

Cataract surgery, which involves removing the cataract and implanting an IOL, is required when a patient’s cataract interferes with his or her daily activities, or if it prevents the patient from receiving treatment for a separate eye condition, according to the National Eye Institute.

Alcon—the subject of a turnaround plan announced early last year to remedy its slumping sales—gave Novartis an unexpected boost in the second quarter this year with a 3% increase to $1.5 billion.