Alcon, the global leader in eye care and a division of Novartis, has received approval from the US Food and Drug Administration (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, research and development 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, M.D. 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). Alcon will commercialize the AcrySof IQ ReSTOR +2.5 D IOL in the United States 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.
A cataract is a clouding of the natural lens of the eye that affects vision. As a cataract develops, the eye's lens gradually becomes hard and cloudy which scatters light rays and allows less light to pass through, which makes it more difficult to see. The vast majority of cataracts happen as a result of normal aging but radiation exposure, taking steroids, diabetes, and eye trauma can accelerate the development of cataracts. Additionally, cataracts can be hereditary and congenital and can present shortly after birth. Cataracts are the most common age-related eye condition and the leading cause of preventable blindness in adults 55 and older. Twenty million people in the US age 40 and older have cataracts. Cataracts are treated by surgically removing the eye's cloudy natural lens and replacing it with an intraocular lens (IOL). More than 98 per cent of cataract surgeries are considered successful and patients can usually return to their normal routines within 24 hours.
Presbyopia is an eye condition that occurs as part of natural aging. It involves the gradual loss of the eye's ability to actively focus on close objects, such as smart phones, computers, books and menus. The first signs of presbyopia are eyestrain, difficulty seeing up close in dim light and problems focusing on small objects and/or fine print. Once a person is in their 40s, it is likely they will experience presbyopia and will require vision correction such as reading glasses or multifocal contact lenses.