Alcon intraocular lens gets FDA's stringent PMA approval

Novartis' ($NVS) Alcon received FDA approval for its implantable AcrySof IQ ReSTOR +2.5 Diopter intraocular lens (IOL), enabling vision correction at all distances in eye care patients with or without presbyopia who undergo cataract surgery.

FDA's approval came via the stringent Premarket Approval, or PMA, pathway for novel or high-risk devices. All IOLs are considered high-risk by the FDA because they are implanted in the eye and replace the light focusing function of the eye's original lens. The device is already approved for use in Europe, Australia, Canada, Japan and Central and South America, and has been implanted almost 27,000 times.

Alcon says 28 million people in the U.S. older than 40 have cataracts, which occurs when the eye's lens becomes hard and cloudy.

The IOL is indicated for "adults with and without presbyopia undergoing cataract surgery who desire near, intermediate and distance vision with increased spectacle independence (or a reduction in the use of glasses)," Alcon's release says. Presbyopia is associated with the body's natural aging process and makes seeing things up close challenging.

"With the addition of AcrySof IQ ReSTOR +2.5 D IOL, surgeons now have a broader range of treatment options to meet the vision needs of cataract patients seeking presbyopia correction, based on various lifestyle requirements," Dr. Lisa Cibik, director of cataract services at Associates in Ophthalmology of Pittsburgh. "The ReSTOR +2.5 D IOL helps surgeons meet the needs of cataract patients with active lifestyles."

In addition to the FDA approval, the Centers for Medicare and Medicaid Services (CMS) has made the IOL eligible for government reimbursement, Alcon said.

Alcon spokeswoman Elizabeth Murphy told FierceMedicalDevices that the device did not go through the advisory panel process.

Meanwhile, Alcon is still awaiting word from the FDA about the AcrySof IQ ReSTOR Multifocal Toric Intraocular Lens. It is for patients suffering from both astigmatism and presbyopia. If approved, it would be first multifocal IOL in the U.S. that corrects corneal astigmatism and provides near, intermediate, and distance vision, the FDA told FierceMedicalDevices.

Alcon says the toric lens combines the benefits of IOLs for correcting astigmatisms (which occurs due to an abnormally shaped cornea or lens) and multifocal IOLs for clearer vision at various distances, as well as correction of presbyopia.

In a sign of the toric lens' greater complexity, it did go through the FDA's Ophthalmic Devices Advisory Committee, where it got overwhelming support. At the meeting, Alcon presented the results of its 570-patient nonrandomized clinical trial of the device.

Like Alcon's just-approved +2.5 IOL, the toric lens is already implanted abroad, with international sales exceeding 93,000 units since 2010.

Alcon reported net sales of $10.8 billion in 2014, an increase of 6% at constant currencies. Sales of surgical products like IOLs and the Centurion Vision cataract removal system grew 7%.

- read the release