Novartis International AG: Alcon AcrySof® IQ PanOptix® trifocal intraocular lens shows superior visual performance in head-to-head trial post-cataract surgery

• Better visual outcomes for patients with the AcrySof IQ PanOptix intraocular lens at near and intermediate distance vision[1]
   
• Detailed findings presented at World Ophthalmology Congress 2018
   
• Recent survey reveals 82% of people 60+ are willing to have advanced surgical options to treat their cataracts and at the same time improve their vision[2]

Basel, June 18, 2018   Alcon, the global leader in eye care and a division of Novartis, unveils new data showing significantly improved near and intermediate distance vision with the AcrySof IQ PanOptix intraocular lens (IOL) compared to the ZEISS AT LISA^®* tri 839MP IOL. These findings further strengthen the value of the PanOptix IOL ENLIGHTEN^TM optical technology, to provide enhanced image quality and more comfortable near to intermediate vision   setting the AcrySof IQ PanOptix IOL apart from other trifocal IOLs. Results from a head-to-head study involving 180 patients were presented today at the World Ophthalmology Congress (WOC), held June 16-18, 2018 in Barcelona, Spain.

"These results underscore the strength of the PanOptix IOL portfolio, and affirm the value of the AcrySof IQ PanOptix IOL for surgeons who want to treat cataracts and correct presbyopia in a single surgery. While 82% of people over 60 are open to this type of advanced surgical option[2], only a few patients are even aware that trifocal IOLs like the AcrySof IQ PanOptix IOL exist," said Michael Onuscheck, President & General Manager, Global Surgical Franchise, Alcon. "As the leader in eye care, it's Alcon's responsibility to continue to deliver innovation that improves patient outcomes, and to connect patients to educational resources that can inform their treatment decisions."

AcrySof IQ PanOptix is the first hydrophobic trifocal lens built on Alcon's proven AcrySof IQ platform. Unlike other leading trifocal IOLs, AcrySof IQ PanOptix has an intermediate focal point at 60 cm, the distance for common intermediate vision activities like using a computer or reading a menu, combined with the excellent rotational and axial stability of the AcrySof single piece design[3]. The design features of the AcrySof platform with the ENLIGHTEN Optical Technology are intended to help patients adapt more naturally to their new lens. The ENLIGHTEN Optical Technology provides an exceptionally high light utilization (88%) and less pupil dependence[4],[5],[6] than previous generations of multifocal IOLs. This lens features a comfortable and continuous range of near to intermediate vision without compromising distance vision.

"At distance vision, AcrySof IQ PanOptix IOL performance is comparable to AT LISA tri 839MP, but at near and intermediate distance, AcrySof IQ PanOptix shows significant superior visual outcomes[1]. These clinical results confirm the superior performance of the Alcon trifocal IOL to perform daily activities like reading books or looking at tablet and smartphone screens," said Ruth Lapid-Gortzak, MD, PhD, Department of Ophthalmology, Academic Medical Center, University of Amsterdam, Netherlands and the Global Coordinating Investigator of the clinical trial.

Results from the trial will be presented during the WOC Congress on Monday, June 18, 14:00-18:00 - Cataract E-Poster Pod Session III. This prospective, multi-center, randomized, double-masked, post-market clinical study involved bilateral implantations and followed 180 patients for six months. The study was designed to clinically qualify bench studies and model predictions of the visual performance of AcrySof IQ PanOptix and the AT LISA tri 839MP Presbyopia Correcting IOL. Results showed the AcrySof IQ PanOptix group had superior visual outcomes at six months in uncorrected intermediate visual acuity at 60 cm (p<0.002) and uncorrected near visual acuity at 40 cm (p<0.003). In addition, the study showed that AcrySof IQ PanOptix was non-inferior in uncorrected distance visual acuity (95 percent SCI <0.1 logMAR)[1].

To raise patient awareness on cataract treatment options, Alcon has developed the More to See campaign, including a survey conducted in 12 countries across Europe, Middle East and Africa in 2017 to understand the knowledge on cataract disease and treatment of consumers aged 60 and over. Results showed that few people (39%) are aware that some surgical options for cataract treatment can also provide vision correction. When asked, the majority (82%) would be willing to have an advanced surgical option that could treat their cataract and improve their vision. These results shows the need for further patient information at time of cataract surgery[2]. More details are available on www.moretosee.org.

*AT LISA^® is a registered trademark owned by or licensed to ZEISS.

About Cataracts
Cataracts are one of the most common age-related eye conditions and one of the leading causes of vision loss[7]. The World Health Organization (WHO) estimates that nearly 18 million people are bilaterally blind from cataracts in the world, making the condition responsible for almost half of all global cases of blindness[8]. A cataract is a cloudy area in the naturally clear lens of the eye that affects vision. The vast majority of cataracts happen because of normal aging, but radiation exposure, taking steroids, diabetes, and eye trauma can accelerate the development of cataracts[9]. As a cataract develops, the eye's lens gradually becomes cloudy, allowing less light to pass through, which makes it more difficult to see[10]. 

About the AcrySof portfolio
The AcrySof IQ portfolio comprises monofocal, toric and multifocal IOLs to address the individual needs of patients with cataract. The AcrySof IQ IOL platform leverages a unique BioMaterial, high-performance BioMechanics and advanced BioOptics to help maximize cataract patient outcomes. Since its first launch in 1994, the AcrySof IOLs have been implanted more than 100 million times, improving the sight and lives of tens of millions of patients over the past 20 years.

Important Information about AcrySof PanOptix IOLs
AcrySof IQ PanOptix was launched in 2015, it is currently available in more than 70 countries worldwide. As with any surgical procedure, there are associated risks. Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens of this type. This is particularly so in a patient with any of the conditions described in the AcrySof IQ PanOptix physician labeling. Some patients may experience visual disturbances and/or difficulty seeing due to the multifocal lens design, especially under dim light conditions. As with other multifocal IOLs, visual symptoms may be significant enough that the patient will request explanation of an AcrySof IQ PanOptix IOL. Posterior capsule opacification (PCO) may significantly affect the vision of patients with multifocal IOLs sooner in its progression than in patients with monofocal IOLs.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations 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 investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products 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; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, 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.

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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 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 124,000 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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References
[1]  Lapid-Gortzak R, Duch F, Elies D, Guarro M, Martinez A. Multicenter Visual Outcomes Comparison of Two Trifocal Presbyopia Correcting IOLs   6 Months Post-op Results. World Ophthalmology Congress. Barcelona 2018.
[2]  More to See campaign survey (EMEA). Alcon data on file. January 2017
[3]  Lee BS, Chang DF. Comparison of the Rotational Stability of Two Toric Intraocular Lenses in 1273 Consecutive Eyes. Ophthalmology 2018
[4]  Gundersen GK, et al. Trifocal intraocular lenses: a comparison of the visual performance and quality of vision provided by two different lens designs. Clinical Ophthalmology 2017:11 1081 1087.
[5]  Estimation of Light Energy Distribution for PanOptix® IOL. Alcon data on file, 2015.
[6]  García-Pérez et al. Short term visual outcomes of a new trifocal intraocular lens. BMC Ophthalmology (2017) 17:72.
[7]  Prevent Blindness. Vision Problems in the U.S. Report. http://www.visionproblemsus.org/cataract.html. Accessed April 2017.
[8]  The International Agency for the Prevention of Blindness. Cataract. https://www.iapb.org/knowledge/what-is-avoidable-blindness/cataract/. Accessed April 2018.
[9]  American Optometric Association (AOA). Causes of Cataract. http://www.aoa.org/patients-and-public/eye-and-vision-problems/glossary-of-eye-and-vision-conditions/cataract?sso=y. Accessed May 2017. 
[10] Cleveland Clinic. Cataracts. http://my.clevelandclinic.org/services/cole-eye/diseases-conditions/hic-cataracts. Accessed August 2015

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