Alcon Strengthens Leadership in IOL Innovation with the launch of the Clareon Presbyopia Correcting IOLs in India

• Clareon PCIOLs deliver excellent vision, exceptional clarity and predictable refractive outcomes in a glistening-free^§ IOL material^12-14
• Clareon IOLs offer long-lasting clarity backed by extensive real-world experience with excellent outcomes, which is demonstrated in 30 peer-reviewed studies^15-17

BENGALURU, India–(BUSINESS WIRE)–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 India. Utilizing Alcon’s most advanced IOL material in its 20+ years of IOL innovation, Clareon delivers consistent visual outcomes and exceptional clarity that lasts.^°,12-18 Clareon’s 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.^†,*,12-14

The Clareon platform is available in India in two PCIOL technologies:

• Clareon PanOptix, which delivers exceptional clarity and offers spectacle independence across all distances with a patient satisfaction rate of 99.2%^31-34;
• PanOptix® Trifocal IOL, implanted over 2.2 million** times, making it the most widely implanted trifocal IOL in the world
• Clareon Vivity with wavefront-shaping X- WAVE™ technology, offering clinically proven exceptionally low rate of visual disturbances and unsurpassed clarity. 9 in 10 (90%) patients were satisfied with their visual outcome and said they would choose Clareon Vivity IOL again for themselves and recommend it for friends and family^4μ‖¶
• Vivity® IOL, designed to extend vision and simplify the presbyopia-correcting experience for surgeons and patients while delivering monofocal- like certainty^1-11

“We are proud to offer the full range of our latest IOL technology to patients in India. At Alcon, we are consistently pushing the boundaries to deliver transformational innovation to cataract surgeons and their patients,” said Amar Vyas, Country Head of Alcon India. “Clareon builds on Alcon’s long legacy of IOL innovation and is the result of robust R&D efforts at every level—inventive material science, advanced manufacturing techniques and novel delivery systems. Our most advanced platform to date, Clareon delivers 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.¹⁹ Clareon IOLs offer sharp, crisp vision with a proprietary edge designed to help reduce glare and posterior capsular opacification.¹³ The lens’ unique and proven STABLEFORCE^® Haptics provide superior axial and rotational stability.^*,β,19,20 Clareon IOLs have been extensively researched, with inclusions in 30 published studies worldwide.

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.²²

More than 28 million cataract surgeries are 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 2045.²⁸

“As one of the early adopters of Clareon IOLs, I am impressed with the clarity of the new IOL material, delivery system and consistent refractive outcomes,” said Dr. Shail Vasavada. “I’m excited about the possibilities I can offer my patients with confidence, given the high rate of patient satisfaction.”

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.^¥,23 PanOptix is the most implanted trifocal lOL worldwide and delivers an exceptional high-quality visual experience from far to near, with 99% patient satisfaction.^{β, 23-25} PanOptix has been implanted over 2.2 million times, with more than 9 out of 10 patients being completely spectacle-free at all distances. ^24,26

Clareon Vivity is an extended depth of focus lens with wavefront-shaping X-WAVE™ technology, delivering monofocal-quality distance with excellent intermediate and functional near vision and a monofocal visual disturbance profile.²⁷ Vivity provides surgeons with an alternative option for cataract patients who may not be eligible for a diffractive IOL, but are seeking presbyopia correction during surgery.

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.²⁹ 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 hours³⁰

About Clareon IOLs and Delivery Systems

The Clareon Family of intraocular lenses (IOLs) includes the Clareon Aspheric Monofocal and Clareon Aspheric Toric IOLs, the Clareon PanOptix Trifocal Hydrophobic IOL, Clareon PanOptix Toric IOL, Clareon Vivity Extended Vision 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 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.com.

^*Compared to TECNIS OptiBlue, Eternity W-60, and EnVista. Trademarks are the property of their respective owners

^** Paid consultant of Alcon

^§”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 20/20-2or better indicates a logMAR VA of 0.04 or better, which means 3 or more of the5 ETDRS chart letters in the line were identified correctly

^βBoth AcrySof and Clareon are designed with STABLEFORCE Haptics

^μResults 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.

^‖ AcrySof® IQ Vivity® was tested. Clinical studies were performed on the AcrySof IQ Vivity® IOL; AcrySof IQ Vivity® and Clareon® Vivity® are optically equivalent

^¶ Response to the following question in IOLSAT questionnaire at 6 months post-op: “Given your vision today, if you had to do it all over, would you have the same lens implanted again?

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. 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.
13. 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.
14. Clareon® IOL Directions for Use.
15. 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/.
16. 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.
17. ILJ466-P003 CSR, Sections 1-11 (v0.36) V-RIM-0049247.
18. 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.
19. 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.
20. 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.
21. Alcon Data on File, 2021.
22. CLAREON MONARCH IV IOL Delivery System – Instructions for Use_11/2021
23. 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
24. Market Scope 2022 IOL Market Report
25. Alcon data on file, REF-18881, 2022
26. Ref: Zhu D. et al., Rate of Complete Spectacle Independence with a Trifocal Intraocular Lens: A Systematic Literature Review and Meta-Analysis, Journal of Ophthalmology and Therapy, 02/2023
27. Clareon Vivity Instructions For Use, 02/2022
28. Lindstrom, Richard L. (2021). Future of cataract surgery seems promising. Healio. https://www.healio.com/news/ophthalmology/20210126/future-of-cataract-surgery-seems-promising, accessed 5th of May 2023.
29. Flaxman, Seth R., et al. (2017). Global causes of blindness and distance vision impairment 1990-2020: a systematic review and meta-analysis
30. National Institute for Health and Care Excellence, Cataracts in Adults: Management. Accessed September 2020.
31. Böhm M, Petermann K, Hemkeppler E, Kohnen T. Defocus curves of 4 presbyopia-correcting
    
    IOL designs: Diffractive panfocal, diffractive trifocal, segmental refractive, and extended-depth-of-focus. J Cataract Refract Surg. 2019;45(11):1625-1636. Doi:10.1016/j.jcrs.2019.07.014
32. Kohnen T, Herzog M, Hemkeppler E, et al. Visual Performance of a Quadrifocal (Trifocal) Intraocular Lens Following Removal of the Crystalline Lens. AM J Ophthalmol. 2017;184:52-62. doi:10.1016/j.ajo.2017.09.0916
33. Clareon® PanOptix Directions for Use, 08/2021; www.ifu.alcon.com
34. 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

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