Alcon receives FDA approval of new multifocal intraocular lens to treat cataract patients in the United States

Apr 16, 2015
  • US Food and Drug Administration (FDA) grants approval of the AcrySof® IQ ReSTOR® +2.5 Diopter (D) Intraocular Lens (IOL) for sale in the US  
  • Expands Alcon's IOL portfolio for the  correction of near, intermediate and distance vision in patients undergoing cataract surgery, with increased independence from glasses  
  • More than three million cataract surgeries are performed each year in the US

Basel, Switzerland, April 16, 2015 - 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.[1]
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).[2] 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.

About Cataracts
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.[2] Cataracts are the most common age-related eye condition and the leading cause of preventable blindness in adults 55 and older.[3] Twenty million people in the US age 40 and older have cataracts.[4] Cataracts are treated by surgically removing the eye's cloudy natural lens and replacing it with an intraocular lens (IOL). More than 98 percent of cataract surgeries are considered successful and patients can usually return to their normal routines within 24 hours.[5]

About Presbyopia
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.[6] 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.[7]

Important Information About AcrySof ReSTOR IOLs
Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the AcrySof ReSTOR physician labeling.  Some patients may experience visual disturbances and/or discomfort due to multifocality, especially under dim light conditions.  As with other multifocal IOLs, visual symptoms may be significant enough that the patient will request explant of an AcrySof ReSTOR IOL.  Clinical studies with the AcrySof ReSTOR lens indicated that posterior capsule opacification (PCO) may significantly affect the vision of patients sooner in its progression than patients with monofocal IOLs. 

Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as "can," "may," "should," or similar terms, or by express or implied discussions regarding potential additional marketing approvals for the AcrySof IQ ReSTOR +2.5 Diopter Intraocular Lens , or regarding potential future revenues from the AcrySof IQ ReSTOR +2.5 Diopter Intraocular Lens . You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the AcrySof IQ ReSTOR +2.5 Diopter Intraocular Lens will be submitted or approved for sale in any additional markets, or at any particular time. Nor can there be any guarantee that the AcrySof IQ ReSTOR +2.5 Diopter Intraocular Lens will be commercially successful in the future. In particular, management's expectations regarding the AcrySof IQ ReSTOR +2.5 Diopter Intraocular Lens could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2014, the Group achieved net sales of USD 58 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). As of December 31, 2014 Novartis Group companies employed approximately 133,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit http://www.novartis.com.

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References
[1] Riley AF, Grupcheva CN, Malik TY, Craig JP, McGhee CN. The Auckland Cataract Study: demographic, corneal topographic and ocular biometric parameters. Clin Experiment Ophthalmol 2001;29:381-6.
[2] NIH, NEI, Facts About Cataracts, September 2009. Available at: http://www.nei.nih.gov/health/cataract/cataract_facts.asp
[3] National Institutes of Health (NIH), National Eye Institute (NEI), Eye Health Needs of Older Adults Literature Review, 2007. Available at: http://www.nei.nih.gov/nehep/research/The_Eye_Health_needs_of_Older_Adults_Literature_Review.pdf
[4] Centers for Disease Control and Prevention (CDC), Common Eye Disorders, July 2009. Available at: http://www.cdc.gov/visionhealth/basic_information/eye_disorders.htm#4
[5] Eye Surgery Education Council, Cataract Surgery, accessed August 2013. Available at: http://eyesurgeryeducation.org/surgery-optionscataract-about.php
[6] Mayo Clinic, Presbyopia. http://www.mayoclinic.com/health/presbyopia/DS00589. [accessed July 1, 2014].
[7] Market Scope, Global Presbyopia-Correcting Surgery Market Report, April 2012.  

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