• Clareon Vivity is the first and only non-diffractive extended depth of focus (EDOF) IOL with the wavefront-shaping X-WAVE Technology on Alcon’s most advanced lens platform^1-6
• Clareon Vivity joins Alcon’s existing portfolio of IOLs for cataract patients who are looking for presbyopia correction with a monofocal-like visual disturbance profile^1-11
• Clareon Vivity is designed to provide a superior halo profile compared to diffractive EDOF lenses^12-13

TORONTO / Nov 08, 2023 / Business Wire / Alcon, the global leader in eye care dedicated to helping people see brilliantly, today announced that Clareon^® Vivity^®, the first and only non-diffractive extended depth of focus (EDOF) intraocular lens (IOL) on Alcon’s most advanced lens platform, is now available in Canada.^1-6 Cataracts are the most common cause of vision loss globally.¹⁴ However, with options such as Clareon Vivity, surgeons can offer cataract patients a lens designed to provide high-quality vision from distance to functional near with a visual disturbance profile demonstrated to be comparable to that of a monofocal IOL.^1,3,4

“At Alcon, we are always looking to bring new innovations to our surgeons with the ultimate goal of helping them deliver optimal outcomes for their patients,” said Mark Newson, Country Business Unit Head, Surgical Division. “Vivity has been a game changer for surgeons and their patients, offering some spectacle independence but also having a visual disturbance profile demonstrated to be comparable to that of a monofocal. Now it is available on Clareon, a pristine, glistening-free* material with among the lowest levels of haze and sub surface nanoglistenings (SSNGs) compared to leading competitor IOLs.” ^6,15-17

Clareon Vivity joins the Clareon Collection of IOLs and is designed for patients seeking a continuous extended range of vision. Clareon Vivity leverages a wavefront shaping optic principle, trademarked as X-WAVE^TM technology, to extend depth of focus and provide a monofocal like visual disturbance profile.^1-6 The Clareon Vivity IOL demonstrated proven results and high levels of patient satisfaction, and is designed to provide a similar halo profile when compared to a monofocal IOL.^1,3,4 Additionally, a clinical trial of the AcrySof^® IQ Vivity IOL showed that the IOL delivered excellent quality distance vision (20/20), excellent intermediate vision (>20,25) and functional near vision (20/32).^3,4,18

“Clareon Vivity is an excellent lens option that can both improve vision, decrease spectacle dependence, and give my patients the freedom to do the activities they love. I’ve been able to expand my IOL offerings to more patients who can take advantage of advanced IOL technology to correct their vision at the time of cataract surgery,” said Dr. Ike Ahmed, MD, FRCSC, Chief Innovation Officer at Prism Eye Institute, Canada. “I’m excited to offer my patients the benefits of Vivity, but now with a glistening-free* material for exceptional clarity.”^†

Clareon Vivity features wavefront-shaping X-WAVE technology. The X-WAVE technology leverages proprietary transition elements to create advanced and delayed wavefronts, resulting in continuous extended focal range.^1,2 Other key benefits include the IOL’s ability to simultaneously stretch and shift the wavefront without splitting it which increases confidence in hitting refractive targets.^1-4

Alcon Canada offers the complete Clareon Collection of IOLs which includes Clareon Monofocal, Clareon Toric, Clareon PanOptix^®, Clareon PanOptix Toric, Clareon Vivity^® and Clareon Vivity^® Toric—all available in UV-absorbing and blue light filtering foldable options in Canada.

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 result from normal aging, but radiation exposure, taking steroids, diabetes and eye trauma can accelerate their development.²¹ Cataracts are the most common age-related eye condition and the leading cause of preventable blindness.²² Cataracts are treated by removing the eye's cloudy natural lens and surgically replacing it with an intraocular lens or IOL. More than 92 percent of cataract surgeries are considered successful, and patients typically can return to their normal routines within 24 hours.²³

About Clareon IOLs and Delivery Systems

The family of Clareon intraocular lenses (IOLs) includes the Clareon Aspheric Hydrophobic Acrylic and Clareon Aspheric Toric IOLs, the Clareon PanOptix Trifocal Hydrophobic IOL, Clareon PanOptix Toric, Clareon Vivity non-diffractive Extended Vision Hydrophobic Posterior Chamber IOL and Clareon Vivity Toric IOLs. Each of these IOLs is indicated for visual correction of aphakia in adult patients following cataract surgery. In addition, the Clareon Toric IOLs are indicated to correct pre-existing corneal astigmatism at the time of cataract surgery. The Clareon PanOptix lens mitigates the effects of presbyopia by providing improved intermediate and near visual acuity while maintaining comparable distance visual acuity with a reduced need for eyeglasses, compared to a monofocal IOL. The Clareon Vivity lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity while maintaining comparable distance visual acuity. All of these IOLs are intended for placement in the capsular bag. Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting any IOL in a patient with any of the conditions described in the Directions for Use that accompany each IOL. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon, informing them of possible risks and benefits associated with these IOLs. Reference the Directions for Use labelling for each IOL for a complete listing of indications, warnings and precautions.

About The Alcon Experience Academy

The Alcon Experience Academy is the umbrella for Alcon’s industry-leading training for Eye Care Professionals, supporting staff, residents and students – whether in person, online or through other hands-on experiential learning opportunities. The Alcon Experience Academy offers thousands of courses every year, from immersive virtual reality training and online educational courses, to in-person training at Alcon Experience Centers worldwide. The Alcon Experience Academy website provides training and education resources on disease states, as well as the latest advancements in techniques and approaches for the safe and effective use of Alcon technology. Learn more at www.alconexperienceacademy.com.

About Alcon

Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning over 75 years, 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 25,000 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.ca.

*Glistening free IOL Defined as Modified Miyata grade 0/<25mv/mm2

^†Based on in vitro examinations of glistenings, SSNG and surface haze

References

1. Clareon^® Vivity^® IOL Directions for Use.
2. Alcon Data on File, US Patent 9968440 B2, May 15, 2018.
3. Bala C, et al. Multi-country clinical outcomes of a new nondiffractive presbyopia-correcting intraocular lens. J Cataract Refract Surg. 2022;48(2):136-143.
4. Alcon Data on File. TDOC-0055576. 23-Jul-2019
5. Werner L, Thatthamla I, Ong M, et al. Evaluation of clarity characteristics in a new hydrophobic acrylic IOL in comparison to commercially available IOLs. J Cataract Refract Surg. 2019;45(10):1490-1497.
6. Alcon Data on File. A01970-REP-211731. 12 Jan 2022.
7. Alcon Data on File, TDOC-0056718. 18-Jun-2019 .
8. Ligabue E, et al. ACRYSOF IQ VIVITY: Natural vision at a range of distances provided by a novel optical technology. Cataract & Refractive Surgery Today. April 2020.
9. Alcon Data on file. A02062-REP-043696, Optical Evaluations of Alcon Vivity^®, Symfony*, Zeiss* AT LARA* AT LISA IOLs. Feb 2020 .
10. Lawless M. Insight news. "An IOL to change the cataract surgery paradigm?" available at "https://www.insightnews.com.au/an-iol-to-change-the-cataract-surgery-paradigm/". Accessed Date 17.07.2020.
11. Ike K. Ahmed, et al. The Vivity Extended Depth of Focus IOL: Our Clinical Experience. Cataract & Refractive Surgery Today. February 2021//
12. Alcon Data on File. ILI875-P001. 2021.
13. Guarro M et al. ESCRS 2021. Oral. FP06.
14. World Health Organization. Cataract. Retrieved from https://www.emro.who.int/health-topics/cataract/. (Accessed September 2022)
15. Oshika T, Fujita Y, Inamura M, Miyata K. Mid-term and long-term clinical assessments of a new 1-piece hydrophobic acrylic IOL with hydroxyethyl methacrylate. J Cataract Refract Surg. 2020;46(5):682-687.
16. Alcon Data on File. TDOC-0057291. 10 Mar 2020.
17. Stanojcic N, O’Brart D, Hull C, et al. Visual and refractive outcomes and glistenings occurrence after implantation of 2 hydrophobic acrylic aspheric monofocal IOLs. J Cataract Refract Surg. 2020;46(7):986-994.
18. AcrySof IQ Vivity IOL DFU.
19. Clareon Monarch IV IOL Delivery System – Proposed Instructions for Use
20. Clareon^® Vivity^® AutonoMe IOL Directions for Use.
21. Cataract Data and Statistics. National Eye Institute. Accessed June 10, 2022. Click here to access the resource.
22. Centers for Disease Control and Prevention, Vision Health Initiative. Accessed June 2, 2022. https://www.cdc.gov/visionhealth/basics/ced/index.html
23. National Institute for Health and Care Excellence, Cataracts in Adults: Management. Accessed June 2022.

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