Alcon Receives FDA Approval of New Multifocal Intraocular Lens to Treat Cataract Patients in the US

Alcon, the global leader in eye care and a division of Novartis, has received approval from FDA for its AcrySof IQ ReSTOR +2.5 Diopter (D) Intraocular Lens (IOL) for patients undergoing cataract eye surgery who choose to address their near, intermediate, and distance vision needs at the same time. The AcrySof IQ ReSTOR +2.5 D IOL is the latest addition to Alcon's broad portfolio of intraocular lenses for cataract patients and provides an additional option to meet the visual needs of each individual patient.

"We are pleased by the FDA's decision to approve our AcrySof IQ ReSTOR +2.5 D IOL," said Sabri Markabi, Senior Vice President, R&D for Alcon. "This technology complements our existing AcrySof IQ ReSTOR +3.0 D IOL in the marketplace, providing more presbyopia-correcting options for ophthalmic surgeons and the patients they serve."

More than three million cataract surgeries are performed each year in the United States. Without presbyopia-correcting IOLs, most patients undergoing cataract surgery experience poor near vision requiring vision correction such as reading glasses or contact lenses. The AcrySof IQ ReSTOR +2.5 D IOL is indicated for adult patients with and without presbyopia undergoing cataract surgery who desire near, intermediate and distance vision with increased spectacle independence.

"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," said Lisa Cibik, FACS, Director of Cataract Services at Associates in Ophthalmology of Pittsburgh, PA. "The ReSTOR +2.5 D IOL helps surgeons meet the needs of cataract patients with active lifestyles."

The Centers for Medicare and Medicaid Services (CMS) added the AcrySof IQ ReSTOR +2.5 D IOL to the list of CMS recognized presbyopia-correcting IOLs, confirming that AcrySof IQ ReSTOR +2.5 D IOLs will be eligible for reimbursement as both a Medicare-covered service (treatment of cataract) and as a non-covered service (presbyopia correction).[2] Alcon will commercialize the AcrySof IQ ReSTOR +2.5 D IOL in the US in the near future. The product is already commercially available in the European Union, Australia, Canada, Japan and countries in Central and South America. Close to 27,000 AcrySof IQ ReSTOR +2.5 D IOLs have already been implanted in the countries where they are commercially available.