Robust data demonstrates extremely high level of patient satisfaction and increased spectacle independence for PanOptix® and Vivity™ PCIOLs – underpinning the strength of these market-leading technologies1-8
ARGOS® Biometer with Image Guidance delivers substantial time efficiencies for cataract surgery practices, surgeons and patients9
More than 60 abstracts highlighting the benefits of the Alcon innovation
FORT WORTH, Texas, July 22, 2021--(BUSINESS WIRE)--Regulatory News:
Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people See Brilliantly, will present a breadth of data during the American Society of Cataract and Refractive Surgery (ASCRS) 2021 annual meeting, taking place July 23-27 in Las Vegas. More than 60 abstracts featuring Alcon ophthalmic products and equipment will be presented, reinforcing the Company’s industry-leading portfolio. The full abstract book, registration links for events taking place onsite and booth information is available at MyAlconatASCRS.com.
"We are thrilled to be back in person at a large-scale meeting with our ophthalmology community for the first time since 2019," said Sergio Duplan, President, North America at Alcon. "Alcon once again has a significant presence at ASCRS, highlighting our ongoing commitment to scientific and technological advancements as we continue to pave the path forward in ophthalmic surgical innovation."
Of the abstracts to be presented, more than half will focus on Alcon’s market-leading presbyopia-correcting intraocular lens technologies, including AcrySof® Vivity™ IQ IOL, AcrySof® PanOptix® IOL as well as the novel Clareon® IOL. The optical designs and material of these IOLs provide patients a variety of options to See Brilliantly, reinforcing Alcon’s commitment to innovation in this space.
Reduced Spectacle Dependence and High Patient Satisfaction with VivityTM IOL, the first and only non-diffractive extended depth of focus (EDOF) IOL in the U.S.10
Key data continues to demonstrate that Vivity delivers an extended range of vision while maintaining a monofocal-like visual disturbance profile.1-4,10 Study findings are based on real-world, patient-reported outcomes for those implanted with the Vivity lens.1-4 The data affirms the results from a Vivity U.S. clinical trial, which demonstrated:
94% and 92% of Vivity patients reported very good or good vision at distance and arm’s length, respectively, without glasses in bright light, with vision of 20/20 at distance, greater than 20/25 at intermediate and functional near (20/32).10,11*†
90% of patients implanted with Vivity™ were satisfied with their results and would get the lens again.11*‡
Presentations will also showcase additional Vivity results and key findings, including:
The Revive Study: Long Term Outcomes of a Novel Non-Diffractive Extended Vision IOL Versus Monofocal Control IOL, Presented by Dr. Brian M. Shafer (July 25, 1:55-2:00 PM).
Visual Outcomes and Quality of Vision after Implantation of a New Presbyopia-Correcting Intraocular Lens with a Non-Diffractive Design, Presented by, Dr. Cathleen McCabe (July 25, 9:10-9:15 AM).
Visual Performance of Non-Diffractive Extended Depth of Focus and Neutral Aspheric Monofocal Intraocular Lens, Presented by Dr. Seth Pantanelli (July 25, 10:00-10:05 AM).
PanOptix® Trifocal IOL Provides Excellent Continuous Vision.12,13 PanOptix is the first and only trifocal IOL in the U.S. and is the most implanted trifocal IOL in the world.
With PanOptix, 20/20 near, intermediate, and distance vision is now possible.13±° A meta-analysis of U.S. and worldwide data reinforces that PanOptix IOL provides patients continuous 20/25 or better vision from distance to near (33cm/13in);12 additional key presentations include:
A Prospective Randomized Comparison of Bilaterally Implanted Extended Depth of Focus and Trifocal Intraocular Lenses, Presented by Dr. Satish S. Modi (July 26, 10:05-10:10 AM).
A Cost-Benefit Analysis Comparing Trifocal Intraocular Lens (IOL) with Monofocal IOL from Patient Perspective in the USA, Presented by Dr. John P. Berdahl (July 26, 10:55-11:00 AM).
Evaluation of Quality of Vision and Spectacle Independence with Bilateral Implantation of a New Trifocal Intraocular Lens, Presented by Dr. Andrew C. Shatz (July 24, 8:00-8:05 AM).
ARGOS® Biometer Delivers Substantial Time Efficiencies to Cataract Surgery Practices, Surgeons and Patients, as the industry-leading Swept Source Optical Coherence Tomography (SS-OCT) biometer equipped with image guidance for a faster and smarter planning solution.14-18
At Alcon, we know that connectivity matters, and data being presented at ASCRS highlights that ARGOS delivers substantial time efficiencies for cataract surgery practices, surgeons, and patients through its superior acquisition rate and integration functionality.9 This time-efficiency model showed that for every 1,000 patients receiving a toric IOL, integrating ARGOS with image guidance can save 58 hours and 51 minutes versus LENSTAR alone.9 Additional studies on ARGOS will be presented, including:
Comparing the Toric Calculations with the Keratometric Readings from a Swept-source OCT Biometer Versus a Scheimpflug Topographer, Presented by Dr. H. John Shammas (July 25, 4:00-4:05 PM).
Targeted Literature Review of the Current Burden and Outcomes of Cataract Surgery with and without Image Guided Systems, Presented by Dr. Sam Multack (July 23, 7:00-8:00 PM).
NGENUITY® 3D Visualization System Heads-Up Display Brings Ergonomics to Surgical Experience; leading 3D visualization system provides precision, depth and detail during cataract and vitreoretinal surgery.19
In a new assessment of musculoskeletal (MSK) complaints, more than 80% of ophthalmologists reported exacerbated MSK pain from the postural position required when examining patients and performing surgery with traditional binocular microscopes – up from 50-70% reported in prior studies.20 A different study found that the postural musculature was less activated with the NGENUITY 3D Heads-up Display (HUD) than with Traditional Microscope (TOM) in Ophthalmic Surgery. Alcon will present these studies along with other key data at the meeting to further explore the benefits of implementing the NGENUITY 3D HUD in Surgical practices:21
Prospective Randomized Evaluation and Comparison of the Effect of Decreased Illumination on Visual Recovery Following Cataract Surgery, Presented by Dr. Eric D. Rosenberg (July 26, 10:47-10:52 AM).
Other studies of note will be presented at the meeting including, but not limited to:
Clinical and Refractive Outcomes after Topography-Guided Refractive Surgery Planned Using Phorcides Analytic Surgery Planning Software, Presented by Dr. Mark C. Lobanoff (July 25, 8:05-8:10 AM).
In-Vitro Comparative Analysis of the Cavitation and Particle Image Velocimetry Characteristics of Two Phacoemulsification Tips, Presented by Dr. Jamie Zacharias (July 24, 8:40-8:45 AM).
Comparison Between Systane iLux and Lipiflow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-Month, Multicenter Study, Presented by Dr. Joseph Tauber (July 24, 2:37-2:42 PM).
Alcon will be bringing connectivity to life during ASCRS with a series of interactive activities. Watch this space as the Company continues to innovate in digital health. Follow along on Alcon social channels and join the conversation at #ConnectBrilliantly. Visit the Alcon booth (#3601) during the meeting to learn more about our surgical products and services, as well as our dry eye devices portfolio, which helps doctors see and restore the ocular surface health of their patients. For information on Alcon events, activations and abstracts, please visit MyAlconatASCRS.com.
About ARGOS® Biometer with Image Guidance
ARGOS is a non-invasive, non-contact biometer based on sweptsource optical coherence tomography (SS-OCT). The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraocular lens placement. Please refer to the ARGOS User Manual for a complete description of proper use and maintenance, optical and technical specifications, as well as a complete list of warnings and precautions.
About the AcrySof® IQ VivityTM IOL
The non-diffractive AcrySof® IQ VivityTM Extended Vision Posterior Chamber Intraocular Lens Model DFT015 (referred to as AcrySof® IQ VivityTM IOL) is a UV-absorbing and blue light filtering foldable intraocular lens (IOL). This IOL, compared to a monofocal IOL, provides an extended range of vision from distance to near without increasing the incidence of visual disturbances.
Potential side effects: As with any surgery, there is an implicit risk, whether or not the IOL is implanted. The complications of the IOL implantation surgery ranges from minor side effects (usually temporary) to serious complications. Patients with previous illnesses or disorders (such as chronic infections of the eye or eyelids, or diabetes) may present a higher risk of complications. Temporary surgical complications include, but are not limited to, reactions to medications such as irritation or mild allergic response, bleeding, redness, itching of the eye, sensitivity to light, swelling, corneal edema (swelling of the cornea), problems with the iris, cell growth in the IOL, and an increase temporary eye pressure. There is a small risk of needing further surgical treatment (such as IOL replacement implanted by a different one or surgery to improve vision) after the implantation of the initial IOL.
About the AcrySof® IQ PanOptix® Trifocal Intraocular Lens (IOL)
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.
Potential Side Effects: 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 the Clareon® Aspheric Hydrophobic Acrylic IOL with the AutonoMe® Automated Pre-loaded Delivery System
The Clareon® Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) is an artificial lens implanted in the eye of adult patients following cataract surgery.
Potential side effects: As with any surgical procedure, there are risks involved. These risks may include, but are not limited to: infection; damage to the ocular structures – lining (inner surface) of the cornea; damage to the iris (the colored diaphragm around the pupil); the retinal layer that lines the inside back wall of your eye may become separated from the tissue next to it (retinal detachment); inflammation or swelling inside or outside the eye; an increase in eye pressure that may not be controlled by medicine; and you may need second surgical procedure. There is a possibility that this IOL could be placed incorrectly or could move within the eye. This may result in less improvement or a reduction in vision, or it may cause visual symptoms.
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.
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 23,000 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.
Allen, Quentin B., MD. Site Level Data from a Multicenter Study of Patient Profiles, Satisfaction, and Visual Range of a Novel Non-Diffractive Extended Vision IOL. ASCRS, Las Vegas, NV. 25 July 2021.
Hovanesian, John A., MD. Evaluation of a Non-Diffractive Multifocal IOL (Vivity) for Glare/Haloes, Spectacle Independence, and Patient Satisfaction. ASCRS, Las Vegas, NV. 25 July 2021.
Shafer, Brian M., MD. The Revive Study: Long Term Outcomes of a Novel Non-Diffractive Extended Vision IOL Versus Monofocal Control IOL. ASCRS, Las Vegas, NV. 25 July 2021.
Shafer, Brian M., MD. One Year, Site-Level Outcomes of a Novel Non-Diffractive Extended Vision Intraocular Lens Versus Control. ASCRS, Las Vegas, NV. 25 July 2021.
Blehm, Clayton G., MD. Evaluating Visual Acuity and Spectacle Independence After Bilateral Implantation of a Trifocal Intraocular Lens. ASCRS, Las Vegas, NV. 24 July 2021.
Chang, John So-Min, MD. Early Clinical Outcome of a Trifocal Intraocular Lens in Asian Eyes. ASCRS, Las Vegas, NV. 23 July 2021.
Greenwood, Michael D., MD. Outcomes and Patient Satisfaction of a Trifocal IOL in Post-Refractive Patients. ASCRS, Las Vegas, NV. 24 July 2021.
Mueller, Brett H. II, DO, PhD. Prospective Analysis to Assess Placing a Panoptix Trifocal LENS in Patients Who Have HAD Myopic Laser Vision Correction Surgery. ASCRS, Las Vegas, NV. 26 July 2021.
Woodard, Lawrence, MD. Time Efficiency of an Innovative Optical Biometer in Cataract Surgery: A Time-and-Motion Study. ASCRS. Las Vegas, NV. 23 July 2021.
AcrySof® IQ Vivity™ Extended Vision IOL DFU. Alcon Laboratories, Inc.; 2020.
Alcon Data on File. 2019.
Maxwell, Andrew W., MD, PhD. Post-operative Visual Outcomes with a Diffractive Trifocal Intraocular Lens: A Meta-analysis of USA and Worldwide patients. ASCRS, Las Vegas, NV. 26 July 2021.
AcrySof® IQ PanOptix DFU. Alcon Laboratories, Inc.; 2019
Tamaoki A, Kojima T, Hasegawa A, et al. Clinical Evaluation of a New Swept-source Optical Coherence Biometer That Uses Individual Refractive Indices to Measure Axial Length Cataract Patients. Ophthalmic Res. 2019;19;1-13.
Shammas HJ, Ortiz S, Shammas MC, Kim SH, Chong C. Biometry Measurements Using a New Large Coherence-Length Swept-Source Optical Coherence Tomographer. J Cataract Refract Surg. 2016; 42:50-61.
Hussaindeen JR, Mariam EG, Arunachalam S, et al. Comparison of Axial Length Using a New Swept-Source Optical Coherence Tomography-Based Biometer. PLOS One. December 2018.
Zeiss IOL Master 700 510k Submission 2015.
Whang, Woong-Joo. Predictive Accuracy of Partial Coherence Interferometry and Swept-source Optical Coherence Tomography For Intraocular Lens Power Calculation. Scientific Report. September 2018.
Alcon Data on File. 2016.
Tan, Nicholas E., Assessment of Musculoskeletal Complaints among Ophthalmologists. ASCRS, Las Vegas, NC. 26 July 2021.
Hura, Arjan, MD. Intraoperative Electromyogram Analysis of Postural Musculature with 3D Heads-up Display vs. Traditional Microscope in Ophthalmic Surgery. ASCRS, Las Vegas, NV. 26 July 2021.
*Results from a prospective, randomized, parallel group, subject- and assessor-masked, multisite trial of 107 subjects bilaterally implanted with the AcrySof® IQ Vivity™ IOL and 113 with the AcrySof® IQ IOL with 6 months’ follow-up. Patient-reported outcomes for spectacle independence were evaluated subjectively through IOLSAT questionnaire.
‡In response to the question asked 6 months after surgery: "Given your vision today, if you had to do it all over, would you have the same lens implanted again?"
†Patients were asked, "How well did you see without wearing eyeglasses in the past 7 days?" Patients who reported not using glasses at least some of the time were asked to rate their quality of vision.
±Based on mean value of binocular defocus curve at near, intermediate, and distance at 6 months (n=127).
°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.
This press release contains "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "commitment," "look forward," "maintain," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties and risks that are difficult to predict. Some of these factors are discussed in our filings with the United States Securities and Exchange Commission, including our Form 20-F. Should one or more of these uncertainties or risks materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated. Therefore, you should not rely on any of these forward-looking statements.
Forward-looking statements in this press release speak only as of the date of its filing, and we assume no obligation to update forward-looking statements as a result of new information, future events or otherwise.
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