Alcon to Highlight AcrySof IQ PanOptix Trifocal IOL Launch and Groundbreaking IOL Data at American Academy of Ophthalmology Annual Meeting

• PanOptix, the first and only advanced trifocal lens for U.S. patients undergoing cataract surgery, will be showcased in educational events and clinical data presentations
• First-ever analyses on IOLs from the AAO IRIS Registry – the largest real-world dataset in ophthalmology – will be presented, supporting the clinical value of the AcrySof platform
• Additional educational opportunities will take place at the Alcon booth (#539) including Surgeon2Surgeon presentations and virtual reality learning modul 

SAN FRANCISCO–(BUSINESS WIRE)–Regulatory News:

Alcon, the global leader in eye care dedicated to helping people see brilliantly, today announced its plans to lead a wide-range of informational and peer-to-peer educational programs at the American Academy of Ophthalmology (AAO) Annual Meeting on October 12-15 in San Francisco, CA. The newly launched AcrySof^® IQ PanOptix^® Trifocal Intraocular Lens (IOL), along with findings from the AAO IRIS^® (Intelligent Research in Sight) Registry, will be part of the scientific program.

“We are thrilled to showcase PanOptix, the first and only advanced trifocal IOL approved in the U.S., at the meeting, underscoring our continued commitment to innovation,” said Sergio Duplan, Region President, North America. “However, our focus goes beyond just bringing new products to the market. We are also dedicated to ongoing learning about our current portfolio as shown with the AAO IRIS Registry, which has allowed us to use an unprecedented amount of real-world data to help validate the performance of our AcrySof platform.”

Showcasing PanOptix, the First and Only FDA-approved Advanced Trifocal IOL

PanOptix, which received FDA-approval in August, is the first and only advanced trifocal lens approved in the US. 20/20near, intermediate and distance vision is now possible with this new lens.¹ PanOptix is already one of the leading presbyopia-correcting IOLs, with over 400,000 implants in more than 70 countries. Based on years of experience with the lens, Alcon plans to share best practices and hands-on training, including virtual reality kiosks at the Alcon booth where surgeons can learn first-hand about PanOptix and how it works. Additional highlights will include:

Clinical Presentation

• E-Poster: Evaluation of the Binocular Depth of Focus of a New Trifocal IOL, R. P. Lehmann

Peer-to-Peer Learning

• Feel the Thrill PanOptix launch event where surgeons hear from other surgeons in an interactive format (Saturday, October 12 at 5:30 PM Terra Gallery, 511 Harrison Street)
• Surgeon2Surgeon Talks where clinical trial investigators will share their first-hand clinical experience with the new lens (Alcon Booth, #539)

Investigating the Real-World Performance of IOLs

Alcon has supported prospective real-world evidence studies to better understand outcomes of its products. The studies used the American Academy of Ophthalmology IRIS Registry, the largest clinical specialty database in the world, and were completed in collaboration with Verana Health, the Academy’s data curation and analytics partner. As of September 1, 2019, the IRIS Registry included approximately 253 million patient visits, representing more than 61 million unique patients.

Clinical Presentations

• Paper Presentation, Tuesday, October 15, 11:03 AM – 11:10 AM: Incidence of Monofocal Toric IOL Repositioning: Analysis of the AAO IRIS Registry; B.A. Kramer, J.P. Berdahl
• Paper Presentation, Tuesday, October 15, 11:27 AM – 11:34 AM: The Potential Benefit of Lower-Powered Toric IOLs According to the Astigmatism Fix Database; B.A. Kramer
• E-Poster: Incidence of YAG due to PCO Following IOL Implantation: An Analysis of AAO IRIS Registry; J.D. Horn
• E-Poster: Description of Retrospective EHR-Based Registry Study to Correlate Toric IOL Biomechanics with Repositioning Incidence; B.A. Kramer
• E-Poster: Description of a Retrospective Study Using EHR-Based Registry to Correlate IOL Biocompatibility with YAG; D.C. Terveen
• E-Poster: Comparison of Time to PCO in Two Hydrophobic IOL Materials: An Analysis of the AAO Clinical Registry; B.L. Fisher

Providing Visualization Systems for Both Front and Back of the Eye to US Surgeons

Alcon’s revolutionary NGENUITY^® 3D Visualization System is now available for both the anterior and posterior segments. Clinical presentations about its real-world implementation in “heads-up” cataract surgery will take place during AAO. The Alcon booth will also feature other anterior segment visualization developments, including LuxOR Revalia™ Ophthalmic Microscope, which delivers enhanced visualization during all stages of ophthalmic surgery through unique and personalized LED illumination technology.

In addition, the latest generation of the NGENUITY 3D Visualization System with DATAFUSION for posterior segment surgery, which was recently launched, will be highlighted at the 5^th Annual Retina Film Festival. This latest innovation includes a real-time display of the CONSTELLATION^® Vision System, the leading technology platform for vitreoretinal surgery. It also allows surgeons to control surgical parameters using the graphic user interface and foot pedal.

Clinical Presentations

• Paper Presentation, Sunday, October 13, 4:18 PM – 4:25 PM: Heads-Up Cataract Surgery: Complication Rates, Surgical Duration and Comparison with Traditional Microscopes, R. J. Weinstock
• E-Poster: Heads-Up Cataract Surgery Using NGENUITY System, J. Nemcansky

Peer-to-Peer Learning

• The 5th Annual Retina Exchange Film Festival, an engaging video-based program discussing the latest in surgical retina techniques (Saturday, October 12, 2019 at 5:45 PM, Yerba Buena Center for the Arts)
• Surgeon2Surgeon Talks where surgeons will share their first-hand clinical experience with NGENUITY (Alcon Booth, #539)

All educational content at the AAO Annual Meeting is planned by its program committee, and AAO does not endorse, promote, approve, or recommend the use of any products, devices, or services.

About PanOptix

The AcrySof® IQ PanOptix® Trifocal IOL is a type of multifocal IOL used to focus images clearly onto the back of your eye (retina) to allow clear vision after the cataract removal. In addition, the center of the AcrySof® IQ PanOptix® Trifocal IOL allows for better near (reading) vision and intermediate (computer work) vision versus what a monofocal lens would provide.

Due to the design of multifocal IOLs, there are some side effects that can be associated with the AcrySof® IQ PanOptix® Trifocal IOL models. These may be worse than with a monofocal IOL, including visual disturbances such as glare, rings around lights, starbursts (rays around light sources), and reduced contrast sensitivity (decrease in ability to distinguish objects from their background, especially in dim lighting). These side effects may make it more difficult to see while driving at night or completing tasks in low lighting conditions such as at night or in fog, or in a dimly lit room after surgery as compared to before surgery.

Further, a toric IOL corrects astigmatism only when it is placed in the correct position in the eye. There is a possibility that the toric IOL could be placed incorrectly or could move within the eye. If the toric lens is not positioned correctly following surgery, the change in your astigmatism correction by the IOL, along with any necessary correction with glasses, may cause visual distortions. If the lens rotates in your eye, you may need additional surgery to reposition or replace the IOL.

About LuxOR Revalia™ Ophthalmic Microscope

The LuxOR Revalia™ Ophthalmic Microscope features unique technologies designed to optimize both anterior and posterior procedures, providing superior visualization¹ for every type of ophthalmic surgery. As with all ophthalmic microscopes, exposure during aphakia should be limited to reduce the risk of damage. During aphakia, limit exposure to red reflex light to no more than 7 minutes.

About NGENUITY^® 3D Visualization System

The NGENUITY^® 3D Visualization System consists of a 3D stereoscopic, high-definition digital video camera and workstation to provide magnified stereoscopic images of objects during micro-surgery. It acts as an adjunct to the surgical microscope during surgery displaying real-time images or images from recordings. Please refer to the User Manual for a complete list of appropriate uses, warnings and precautions.

Disclaimer

This announcement contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 that can generally be identified by words such as “commitment,” “may,” “look forward,” “estimates,” “projected,” “will,” “potential,” “anticipate,” “intend,” “plan,” “seek,” “believe,” “expect,” “intention,” “should,” “maintaining” or similar expressions, or by express or implied discussions regarding the potential outcome, or financial or other impact on Alcon or any of its businesses of the separation and spin-off from Novartis; or regarding potential future sales or earnings of Alcon or any of its businesses or potential shareholder returns; or by discussions of strategy, plans, expectations or intentions. 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. There can be no guarantee that Alcon will be able to realize any of the potential strategic benefits or opportunities as a result of the separation and spin-off. Nor can there be any guarantee that shareholders will achieve any particular level of shareholder returns. Nor can there be any guarantee that Alcon, or any of its businesses, be commercially successful in the future, or achieve any particular credit rating or financial results. Nor can we guarantee the separation and spin-off will be successful.

In particular, our expectations could be affected by, among other things: uncertainties regarding the success of our separation and spin-off from Novartis, including our ability to establish the infrastructure needed to operate as a standalone company without significant management distraction or business disruption; and general political, economic and trade conditions, including uncertainties regarding the effects of ongoing instability in various parts of the world.

Some of these factors are discussed in more detail in Alcon’s filings with the United States Securities and Exchange Commission, including its Form 20-F, particularly under “Item 3. Key Information—3.D. Risk Factors”, “Item 4. Information on the Company” and “Item 5. Operating and Financial Review and Prospects”. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. The statements in this announcement are as of the date of its filing. We do not intend, and do not assume any obligation, to update any information or forward-looking statements set out in this announcement as a result of new information, future events or otherwise.

About Alcon

Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning more than seven decades, we offer the broadest portfolio of products to enhance sight and improve people’s lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Our more than 20,000 associates are enhancing the quality of life through innovative products, partnerships with eye care professionals and programs that advance access to quality eye care. Learn more at www.alcon.com.

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References

[1] AcrySof^® IQ PanOptix^® Directions For Use.

*Based on mean value of binocular defocus from curve at near, intermediate and distance at 6 months. Snellen VA was converted from logMAR VA. A Snellen notation of 20/20^-2 or better indicates a logMAR VA of 0.04 or better, which means 3 or more of the 5 ETDRS chart letters in the line were identified correctly.

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