Alcon Strengthens Leadership in IOL Innovation with Launch of Clareon Portfolio in the U.S.

• Clareon family of intraocular lenses (IOLs) delivers excellent vision, exceptional clarity and predictable refractive outcomes in a glistening-free§ IOL material1-3
• Long-lasting clarity of the Clareon IOL and extensive real-world experience with excellent outcomes demonstrated in 30 peer-reviewed studies4-6
• Global rollout of Clareon portfolio has started; U.S. to launch Clareon Monofocal, Clareon PanOptix and Clareon Vivity IOLs in March with additional countries planned throughout 2022

Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced the launch of the Clareon®family of intraocular lenses (IOLs) in the U.S. Utilizing Alcon’s most advanced IOL material, Clareon can deliver consistent visual outcomes and exceptional clarity that lasts.°,1-7 The Clareon clarity is born out of a glistening-free§ IOL material that has among the lowest levels of haze and subsurface nanoglistenings (SSNGs) compared to leading competitor IOLs.†,*,1-3

“We are proud to offer our latest IOL technology in the U.S. and other countries across the globe. At Alcon, we are consistently pushing the boundaries to deliver transformational innovation to cataract surgeons and their patients,” said Ian Bell, President, Global Business & Innovation, Alcon. “Clareon is the result of robust R&D efforts at every level—inventive material science, advanced manufacturing techniques and novel delivery systems—to deliver exceptional, long-lasting clarity.”

The Clareon portfolio leverages many of the same design characteristics and optics as Alcon’s leading IOLs to help deliver the outcomes surgeons expect.8,9 Clareon offers sharp, crisp vision with a proprietary edge designed to help reduce glare and posterior capsular opacification.7 The lens’ unique and proven STABLEFORCE® Haptics provide superior axial and rotational stability.*,ß,8-14 Clareon has been extensively researched, with inclusion in 30 published studies worldwide. Clareon Monofocal and Clareon Toric IOLs have already been implanted in more than one million eyes across more than 70 countries.15

Clareon IOLs are inserted using the next-generation, reusable Clareon Monarch® IVDelivery System, which provides precise and controlled implantation and that was designed specifically for the new Clareon material.15,16 Clareon Monofocal is also available in the next-generation automated, single-use delivery system, AutonoMe™.

“As one of the investigators for the Clareon pivotal trial, I was immediately impressed with the clarity of the new IOL material, delivery system and the consistent refractive outcomes,” said Dr. Samuel H. Lee, MD, Ophthalmologist, Sacramento, CA.** “Today, the clarity of Clareon persists four years later in my trial patients, with the optic performance that I expect from Alcon IOLs, as well as continued high patient satisfaction.”

Clareon Monofocal, Clareon PanOptix®, Clareon PanOptix Toric, Clareon Vivity® and Clareon Vivity Toric IOLs are now available in the U.S. Clareon PanOptix offers patients the possibility of 20/20 vision at distance (far), intermediate (at arm’s length) and near (up close), with continuous vision of 20/25 or better.¥,14,17 Clareon Vivity is a non-diffractive extended depth of focus lens with wavefront-shaping X-WAVE™ technology, delivering monofocal-quality distance with excellent intermediate and functional near vision and with a monofocal visual disturbance profile.13,18

Clareon Toric will be available in the U.S. later this year. Alcon will be rolling out the Clareon family of IOLs in international markets throughout 2022 and 2023.

There are more than 28 million cataract surgeries performed each year in the world. With the aging population and increased life expectancies, these surgeries are expected to increase 3-4% per year for the next 30 years, leading to an estimated 60 million global cataract surgeries annually by 2045.19

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. Cataracts are the most common age-related eye condition and the leading cause of preventable blindness.20 Cataracts are treated by removing the eye's cloudy natural lens and surgically replacing it with an IOL. More than 92% of cataract surgeries are considered successful, and patients typically can return to their normal routines within 24 hours.21

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 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 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 24,000 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.

*Compared to TECNIS, TECNIS OptiBlue, Eternity W-60, Vivinex XY1 and EnVista. Trademarks are the property of their respective owners
**Dr. Lee is a paid Alcon consultant
§ “Glistening-free” is defined as Miyata grade 0 or <25mv/mm2
°Long-term defined as over 3 years (n=138), and over 9 years, n=20 respectively
†Based on in vitro examinations of glistenings, SSNG and surface haze
‡Clareon® and AcrySof® share the same -0.2µm aspheric design resulting in improved depth of focus
¥ Based on the binocular defocus curve at 0D, -1.5D, and -2.5D (n=129). 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
ß Both AcrySof and Clareon are designed with STABLEFORCE Haptics

References

1. Lehmann R, Maxwell A, Lubeck DM, Fong R, Walters TR, Fakadej A. Effectiveness and Safety of the Clareon Monofocal Intraocular Lens: Outcomes from a 12-Month Single-Arm Clinical Study in a Large Sample. Clin Ophthalmol. 2021 Apr 20;15:1647-1657. Doi: 10.2147/OPTH.S295008. PMID: 33907378; PMCID: PMC8068507.
2. Werner L, Thatthamla I, Ong M, Schatz H, Garcia-Gonzalez M, Gros-Otero J, Cañones-Zafra R, Teus MA. Evaluation of clarity characteristics in a new hydrophobic acrylic IOL in comparison to commercially available IOLs. J Cataract Refract Surg. 2019 Oct;45(10):1490-1497. Doi: 10.1016/j.jcrs.2019.05.017. Epub 2019 Aug 6. PMID: 31399323.
3. Clareon® IOL Directions for Use.
4. Maxwell A, Suryakumar R. Long-term effectiveness and safety of a three-piece acrylic hydrophobic intraocular lens modified with hydroxyethyl-methacrylate: an open-label, 3-year follow-up study. Clin Ophthalmol. 2018;12:2031-2037 https://pubmed.ncbi.nlm.nih.gov/30349186/.
5. 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 May;46(5):682-687. Doi: 10.1097/j.jcrs.0000000000000142. PMID: 32358260.
6. ILJ466-P003 CSR, Sections 1-11 (v0.36) V-RIM-0049247.
7. Das KK, Werner L, Collins S, Hong X. In vitro and schematic model eye assessment of glare or positive dysphotopsia-type photic phenomena: Comparison of a new material IOL to other monofocal IOLs. J Cataract Refract Surg. 2019 Feb;45(2):219-227. Doi: 10.1016/j.jcrs.2018.09.017. Epub 2018 Nov 22. PMID: 30471850.
8. Lane, S., Collins, S., Das, K. K., Maass, S., Thatthamla, I., Schatz, H., … & Jain, R. (2019). Evaluation of intraocular lens mechanical stability. Journal of Cataract & Refractive Surgery, 45(4), 501-506.
9. TDOC-0054028 (2017) - Clareon SY60WF Axial Displacement Study at Varied Compressions.
10. Kramer BA, Hardten DR, Berdahl JP. Rotation Characteristics of Three Toric Monofocal Intraocular Lenses. Clin Ophthalmol. 2020 Dec 16;14:4379-4384. doi: 10.2147/OPTH.S285818. PMID: 33364742; PMCID: PMC7751684.
11. Lee BS, Chang DF. Comparison of the Rotational Stability of Two Toric Intraocular Lenses in 1273 Consecutive Eyes. Ophthalmology. 2018 Sep;125(9):1325-1331. doi: 10.1016/j.ophtha.2018.02.012. Epub 2018 Mar 12. PMID: 29544960.
12. Oshika T, Fujita Y, Hirota A, Inamura M, Inoue Y, Miyata K, Miyoshi T, Nakano S, Nishimura T, Sugita T. Comparison of incidence of repositioning surgery to correct misalignment with three toric intraocular lenses. Eur J Ophthalmol. 2020 Jul;30(4):680-684. doi: 10.1177/1120672119834469. Epub 2019 Mar 6. PMID: 30841757.
13. Clareon® Vivity Directions for Use.
14. Clareon® PanOptix Directions for Use.
15. Alcon Data on File, 2021.
16. CLAREON MONARCH IV IOL Delivery System – Proposed Instructions for Use – Final
17. Modi Et al. Visual and Patient-Reported Outcomes of a Diffractive Trifocal Intraocular Lens Compared with Those of a Monofocal Intraocular Lens. 2020 Sep 28;S0161-6420(20)30677-1.
18. Bala, Chandra, et al. Multi-country clinical outcomes of a new nondiffractive presbyopia-correcting intraocular lens. Journal of Cataract and Refractive Surgery Now in Print DOI: 10.1097/j.jcrs.0000000000000712.
19. Lindstrom, Richard L. (2021). Future of cataract surgery seems promising. Healio.
20. Flaxman, Seth R., et al. (2017). Global causes of blindness and distance vision impairment 1990-2020: a systematic review and meta-analysis
21. National Institute for Health and Care Excellence, Cataracts in Adults: Management. Accessed September 2020.

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