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2017-03-23 07:15 CET
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Alcon receives US FDA approval for new AcrySof® IQ ReSTOR® +2.5 Multifocal Toric IOL with ACTIVEFOCUS(TM) design for uncompromised distance vision and presbyopia correction

  • The unique optical design of the ACTIVEFOCUS(TM) toric IOL gives astigmatic cataract patients quality distance vision and an increased range of vision to potentially reduce dependence on glasses
     
  • The lens is based on the proven AcrySof® IQ toric IOL platform that delivers unrivaled rotational stability[1]
     
  • This extends the market-leading AcrySof® IQ platform to a broader population of the nearly 2 million cataract patients with treatable levels of astigmatism who undergo cataract surgery each year[2]

Basel, March 23, 2017 - 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 Multifocal Toric intraocular lens (IOL) with ACTIVEFOCUS(TM) optical design for patients undergoing cataract surgery who choose to address their astigmatism and presbyopia at the same time. The unique optical design of the ACTIVEFOCUS(TM) toric lens delivers both crisp, clear distance vision and a range of vision for patients who desire less dependence on glasses. The ACTIVEFOCUS(TM) toric IOL is the only multifocal toric IOL in which the central portion is 100 percent dedicated to distance vision[3],[4]. Previous presbyopia-correcting IOL designs tend to compromise on distance vision in order to provide patients with a range of vision.

"Presbyopic cataract patients with astigmatism have had limited options in the past," said Sergio Duplan, Region President, North America for Alcon. "Alcon's ACTIVEFOCUS(TM) toric IOL is a breakthrough for these patients, correcting astigmatism and allowing them to achieve uncompromised distance vision with an increased range of vision at the same time."

The ACTIVEFOCUS(TM) toric IOL is also engineered for stability. Toric IOLs perform optimally if they stay on axis to correct the astigmatism. In a retrospective study of IOL orientation data,  the AcrySof® IQ toric IOL platform was 2.5 times less likely to rotate than the leading competitor lens*[1]. Additionally, the AcrySof® IQ toric platform is the market leader with cataract surgeons implanting more than 1.7 million AcrySof® IQ toric IOLs to date[5]. 

"The ACTIVEFOCUS(TM) toric IOL is the marriage of the design features of my two go-to IOLs for patients wanting outstanding distance vision and less dependence on glasses after cataract surgery," said Bret L. Fisher, M.D., Medical Director, Eye Center of North Florida. "By combining the unique optical properties of the ACTIVEFOCUS(TM) design with the unparalleled rotational stability of the AcrySof® IQ toric platform, I can now offer a range of vision to more patients."

Nearly four million cataract surgeries are performed each year in the US, and more than 50 percent of those patients have treatable levels of astigmatism that could be addressed with AcrySof® IQ toric IOLs[2], including the new ACTIVEFOCUS(TM) toric IOL. Astigmatism occurs when the cornea is misshapen, causing blurry vision and distorted images at all distances. Presbyopia occurs in most people over the age of 40 and results in needing vision correction such as reading glasses.

Alcon plans to commercialize the ACTIVEFOCUS(TM) toric IOL in the US beginning in mid-2017.

About Cataracts
A cataract is a cloudy area in the natural lens of the eye that affects vision. As a cataract develops, the eye's lens gradually becomes hard and cloudy allowing 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[6]. Cataracts are the most common age-related eye condition and the leading cause of preventable blindness[7]. Twenty million people in the US age 40 and older have cataracts[8]. Cataracts are treated by removing the eye's cloudy natural lens and surgically replacing it with an intraocular lens or IOL. More than 98% of cataract surgeries are considered successful and patients typically can return to their normal routines within 24 hours[9].

About Astigmatism and Presbyopia
Astigmatism is a variation in the shape or curvature of the cornea and, if left untreated, can cause blurred vision at all distances. 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 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.

Important Information about AcrySof® IQ ReSTOR® +2.5 Multifocal Toric IOL
Side effects associated with the AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL include visual disturbances such as glare, rings around lights, and blurred vision. These side effects may make it more difficult to see while driving at night or completing tasks in low lighting such as at night or in fog, after surgery as compared to before surgery.

This IOL corrects corneal astigmatism only when it is placed in the correct position in the eye. There is a possibility that the IOL could be placed incorrectly or could move within the eye. This may result in less improvement or a reduction in vision because your corneal astigmatism has not been fully corrected, or it may cause visual symptoms.

The safety and effectiveness of the AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL has not been established in patients with certain eye conditions, such as glaucoma or diabetic retinopathy (an increase in eye pressure or complications of diabetes in the eye).

Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as "potentially," "offer," "could," "plans," "can," "may," "likely," "will," or similar terms, or by express or implied discussions regarding potential additional marketing approvals for the AcrySof IQ ReSTOR +2.5 Multifocal Toric IOL, or regarding potential future revenues from the AcrySof IQ ReSTOR +2.5 Multifocal Toric IOL. 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 Multifocal Toric IOL 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 Multifocal Toric IOL will be commercially successful in the future. In particular, management's expectations regarding the AcrySof IQ ReSTOR +2.5 Multifocal Toric IOL could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; 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; safety, quality or 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 Alcon
Alcon is the global leader in eye care. As a division of Novartis, we offer the broadest portfolio of products to enhance sight and improve people's lives. Our products touch the lives of more than 260 million people each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors, and there are millions more who are waiting for solutions to meet their eye care needs. Our purpose is reimagining eye care, and we do this through innovative products, partnerships with eye care professionals and programs that enhance access to quality eye care. Learn more at www.alcon.com.

Alcon is on Facebook. Like us at www.facebook.com/AlconEyeCare

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, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2016, the Group achieved net sales of USD 48.5 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.

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* 1.86% by estimated market usage, n=1,953 vs. 0.75% by estimated market usage, n=3,556.

References

[1] Potvin R, Kramer BA, Hardten DR, Berdahl JP. Toric intraocular lens orientation and residual refractive astigmatism: an analysis. Clin Ophthalmol. 2016;10:1829-1836.
[2] Provided courtesy of Dr. Warren Hill. Accessed March 2017. Available at http://www.doctor-hill.com/iol-main/astigmatism_chart.htm.  
[3] Alcon Data on File. TDOC-0052151 (11 Apr 2016).
[4] Alcon Data on File. TDOC-0053021 (06 Oct 2016).
[5] Alcon Data on File. 2017.
[6] American Optometric Association (AOA), Causes of cataract. Accessed August 2015.  Available at: http://www.aoa.org/patients-and-public/eye-and-vision-problems/glossary-of-eye-and-vision-conditions/cataract?sso=y
[7] World Health Organization (WHO), Causes of blindness and visual impairment: cataract. Accessed May 2016. Available at: http://www.who.int/blindness/causes/en  
[8] Centers for Disease Control and Prevention (CDC), Common Eye Disorders, Accessed August 2015. Available at: http://www.cdc.gov/visionhealth/basics/ced/index.html
[9] Cleveland Clinic. Cataracts.  Accessed August 2015.  Available at: http://my.clevelandclinic.org/services/cole-eye/diseases-conditions/hic-cataracts

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