Alcon Announces CE Mark Approval and Commercialization of Clareon Vivity IOL in Europe, Expanding Visual Possibilities

Rhea-AI Summary

Alcon (ALC) has received CE Mark approval for Clareon Vivity, an extended depth of focus (EDOF) intraocular lens (IOL) for cataract surgery. The commercial rollout in Europe will begin in early Q2 2025, with the AutonoMe automated pre-loaded delivery system available in Q3 2025.

The Clareon Vivity IOL combines Alcon's advanced Clareon material with Vivity's X-WAVE Technology, providing extended vision range from distance to functional near with minimal visual disturbances. Clinical outcomes show over 90% patient satisfaction rates, including successful results in patients with mild comorbidities such as AMD, glaucoma, and dry eye.

Key features include:

• One of the lowest levels of haze and glistenings compared to competitors
• STABLEFORCE Haptics for excellent axial and rotational stability
• Available in both UV-absorbing and blue light filtering options
• Reduced spectacle dependence while maintaining mesopic contrast sensitivity

Positive

• CE Mark approval expands market access in Europe
• High patient satisfaction rate of over 90%
• Proven effectiveness in patients with mild eye comorbidities
• Superior material properties with lowest levels of haze and glistenings
• Reduced need for glasses post-surgery

Negative

• None.

Insights

Medical Technology Analyst

Alcon's CE Mark approval for Clareon Vivity IOL represents a significant expansion of their ophthalmology portfolio in Europe, with commercialization beginning in Q2 2025. This approval strategically combines two of Alcon's key technologies: their market-leading Vivity extended depth of focus (EDOF) platform with their premium Clareon lens material.

The clinical value proposition is compelling: Clareon Vivity delivers extended vision range while maintaining a monofocal visual disturbance profile - effectively offering presbyopia correction without the typical compromises. The reported 90%+ patient satisfaction rates demonstrate strong clinical outcomes, particularly noteworthy given the lens's versatility for patients with comorbidities like AMD, glaucoma and dry eye.

This approval strengthens Alcon's leadership position in the premium IOL segment by completing their Clareon platform lineup, now offering monofocal, toric, PanOptix trifocal, and Vivity EDOF options all on the same advanced material. The expansion addresses high-value market segments - working-age cataract patients seeking spectacle independence and those with comorbidities previously unsuitable for premium IOLs.

The product's compatibility with Alcon's AutonoMe automated delivery system (available Q3 2025) provides further clinical differentiation in the competitive IOL landscape, potentially driving both premium lens adoption and delivery system sales.

Financial Analyst

This CE Mark approval and European commercialization represents a meaningful market opportunity for Alcon, significantly expanding their addressable patient base for premium IOLs. The strategic timing for market introduction in Q2 2025 positions Alcon to capture increased surgical volumes typically seen in mid-year months.

By combining their most advanced technologies (Vivity EDOF and Clareon material) into a single offering, Alcon is executing an effective premium-tier strategy that should drive higher ASPs and margins. Premium IOLs like Clareon Vivity typically command 2-3x higher pricing than standard monofocal lenses, directly benefiting Alcon's surgical segment revenue.

The market opportunity is substantial, given that cataracts affect approximately 10 million patients in Germany alone. The product's ability to address patients with comorbidities expands the premium IOL candidate pool significantly beyond what competitors can target.

Alcon's full Clareon portfolio completion creates competitive differentiation through material consistency across their IOL range, potentially increasing surgeon loyalty and institutional standardization. The phased rollout strategy (manual delivery in Q2, AutonoMe in Q3) creates two distinct catalyst points for adoption, potentially extending the new product growth curve through year-end 2025.

This approval reinforces Alcon's ophthalmology leadership position and should contribute to ongoing share gains in the premium surgical segment, where margins are highest.

• Clareon Vivity IOL provides an extended range of vision from distance to functional near with a monofocal visual disturbance profile^1-3µ‖
• Vivity, the world’s leading EDOF, is now available on Alcon’s Clareon material, providing presbyopia correction with exceptional^† clarity and predictable refractive outcomes^1,4-7
• CE Marked countries will begin commercial rollout of Clareon Vivity and Clareon Vivity Toric from early Q2 2025; also available in AutonoMe automated pre-loaded delivery system in Q3 2025⁸

GENEVA--(BUSINESS WIRE)-- Regulatory News:

Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced that Vivity^®, the most widely implanted⁹ extended depth of focus (EDOF) intraocular lens (IOL), is now available on Alcon’s most advanced lens material—Clareon^®.¹ Clareon Vivity^® received CE Mark and will commence commercial rollout in Europe from early Q2 2025.

"Cataracts are the most common cause of vision loss globally¹⁰, and in Germany alone, 10 million patients are affected by cataracts.¹¹ Due to advancements in cataract surgery and increased awareness of its safety and benefits, my practice has seen a growing number of middle-aged patients seeking early treatment," said Prof. Dr. Ramin Khoramnia, Director of the University Eye Clinic in Dresden. "Many of these patients are still working, very active, and want high-quality vision for both distance and intermediate tasks. With Clareon Vivity, I can provide my patients a presbyopia-correcting IOL, significantly reducing their need for glasses.¹²”

Vivity’s compelling real-world outcomes demonstrate that patients with certain mild comorbidities—such as age-related macular degeneration (AMD), retinopathy/maculopathy, glaucoma, and dry eye—as well as those with post-refractive eyes, can successfully receive presbyopia-correcting IOLs. The study further reported high patient satisfaction rates of over 90% across these diverse eye condition groups.¹²

"Clareon Vivity will broaden my presbyopia correction offering to more patients, including those with ocular comorbidities like glaucoma, age-related macular degeneration (AMD), or dry eyes.¹³ Clareon Vivity’s broad range of dioptres and cylinders will help me address mild, moderate and high refractive error patients with a PCIOL,¹” said Dr. Mercè Guarro, CEO Instituto de Oftalmologia Médica y Quirúrgica OMIQ & Head of Ophthalmology Department at Hospital Granollers. “Clareon Vivity is an excellent lens option that improves vision with a visual disturbance profile of a monofocal IOL, giving my patients the freedom to engage in activities they love, both during the day and at night.”

Clareon is a pristine material with one of the lowest levels of haze and glistenings^*† compared to leading competitor IOLs, marking a significant advancement for surgeons and patients. ^7,14,15 Clareon offers sharp, crisp vision with a proprietary edge designed to help reduce glare and posterior capsular opacification.⁶ The lens’ unique and proven STABLEFORCE^® Haptics provide excellent axial and rotational stability.^5‡

“When we created Vivity, our goal was to develop an innovative lens that would minimize patients' reliance on glasses and simplify presbyopia correction for surgeons. We achieved this by designing a real EDOF lens, which has quickly become the world’s most implanted EDOF. This lens is now available in our most advanced biomaterial to date, Clareon,¹” said Sunil Vasanth, Vice President Surgical Franchise, Europe.

Clareon Vivity leverages a wavefront-shaping optical principle, trademarked as X-WAVE™ Technology, and uses proprietary transition elements to create advanced and delayed wavefronts, resulting in a continuously extended focal range.^1-3µ‖ When compared to an aspheric monofocal, Clareon Vivity reduced spectacle dependence, provided comparable distance vision, and improved intermediate and near vision while maintaining overall mesopic contrast sensitivity. About 90% of the Vivity patients are highly satisfied with their visual outcomes and would choose a Vivity IOL again, and more than 9 in 10 patients said they would recommend Vivity to their friends and family.¹²

Now with the CE Mark of Clareon Vivity and Clareon Vivity Toric, surgeons in Europe have access to the full range of Clareon IOLs to meet the diverse needs of their patients, including Clareon Monofocal, Clareon Toric, Clareon PanOptix^® and Clareon PanOptix Toric – all available in ultraviolet absorbing and blue light filtering foldable options.^1,16,17 Clareon Vivity is inserted using Clareon Monarch^® IV, an easy-to-use, reusable manual delivery system, and is also available in the AutonoMe^® Automated Pre-Loaded Delivery System.^8,18

For more information about Clareon Vivity and Clareon Vivity Toric, please visit MyAlcon.com or speak to your sales representative within Europe.

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. Most cataracts result from normal aging, but radiation exposure, steroid use, diabetes and eye trauma can accelerate their development.^10,19 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 intraocular lens (IOL). More than 92% of cataract surgeries are considered successful, and patients typically return to their normal routines within 24 hours.^19,21

About Vivity

The non-diffractive Clareon Vivity Extended Vision Hydrophobic Posterior Chamber IOLs (referred to as Clareon Vivity) and AcrySof IQ Vivity Extended Vision Posterior Chamber Intraocular Lens Model DFT015 (referred to as AcrySof IQ Vivity IOL) are UV-absorbing and blue-light-filtering foldable intraocular lenses (IOLs). Vivity IOL provides an extended range of vision from distance to near, with low levels 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.¹ 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 after the implantation of the initial IOL.¹

Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the benefit/risk ratio before implanting a lens in a patient with ocular comorbidities as indicated in the IFU.

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.

µ 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.

‖ 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 (AcrySof^® IQ Vivity^® IOL, n=106; monofocal, n=111): “Given your vision today, would you have the same lenses implanted again?”

* Glistening-free is defined as modified Miyata grade 0, <25mv/mm²

† Based on in vitro examinations of glistenings, surface haze and SSNGs; as compared to Clareon^® CNA0T0, TECNIS^§ ZCB00, TECNIS^§ OptiBlue, Eternity^§ W-60 and enVista^§ MX60; n=30 per group; p<.001

‡ Both AcrySof^® and Clareon^® are designed with STABLEFORCE^® Haptics

§ Trademarks are the property of their respective owners.

References

1. Clareon^® Vivity^® Extended Vision Hydrophobic IOL CE Mark – DFU.
2. Alcon Data on File. US Patent 9968440 B2. 15 May 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. 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. doi:10.1016/j.jcrs.2019.05.017.
5. Lane S, et al. Evaluation of intraocular lens mechanical stability. J Cataract Refract Surg. 2019;45:501-506.
6. Das KK, et al. In vitro and schematism 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;45(2):219-227. Doi: 10.1016/j.jcrs.2018.09.017. Epub 2018 Nov 22. PMID: 30471850.
7. 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.
8. Clareon^® Vivity^® Extended Vision Hydrophobic IOL with the AutonoMe^® – CE Mark Directions for Use.
9. Alcon Data on File, 2024.
10. World Health Organization. Cataract. Available at: https://www.emro.who.int/health-topics/cataract/. Accessed: September 2022.
11. Strohlein LM. Cataracts When vision becomes cloudy. Informationsdienst Wissenschaft (idw). January 8, 2019. Accessed June 13, 2023. https://idw-online.de/de/news720054.
12. Alcon Research LLC. Data on File. 2024.
13. Alcon Research LLC. Data on File. 2022.
14. Alcon Data on File, 2020.
15. 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.
16. Clareon^® Aspheric Hydrophobic Acrylic IOL – Directions for Use.
17. Clareon^® PanOptix^® Trifocal UV Absorbing IOL – Directions for Use.
18. Clareon^® Monarch^® IV IOL Delivery System – Proposed Instructions for Use.
19. National Institute for Health and Care Excellence, Cataracts in Adults: Management. Available at: https://pubmed.ncbi.nlm.nih.gov/29106797/. Accessed: June 2022.
20. Centers for Disease Control and Prevention, Vision Health Initiative. Available at: https://www.cdc.gov/vision-health/about-eye-disorders/. Accessed: February 14, 2025.
21. Cataract Surgery Recovery: 8 Tips to Minimize Recovery Time. Allaboutvision.com. Published 2019. Available at: https://www.allaboutvision.com/treatments-and-surgery/vision-surgery/cataract/cataract-surgery-recovery/. Accessed March 15, 2025.

For indications, contraindications and warnings please refer to the relevant product's instructions for use.

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Media Relations

Steven Smith

+ 41 589 112 111 (Geneva)

+ 1 817 551 8057 (Fort Worth)

globalmedia.relations@alcon.com

Investor Relations

Daniel Cravens, Allen Trang

+ 41 589 112 110 (Geneva)

+ 1 817 615 2789 (Fort Worth)

investor.relations@alcon.com

Source: Alcon Inc. Swiss

FAQ

When will Clareon Vivity IOL be available in European markets?

Clareon Vivity will begin commercial rollout in CE Marked European countries from early Q2 2025, with AutonoMe delivery system available in Q3 2025.

What are the key benefits of Alcon's Clareon Vivity IOL for cataract patients?

It provides extended vision range from distance to near, minimal visual disturbances, reduced glasses dependency, and is suitable for patients with mild eye comorbidities.

What is the patient satisfaction rate for Alcon's Vivity IOL?

About 90% of Vivity patients report high satisfaction with visual outcomes, and over 90% would recommend it to friends and family.

How does Clareon Vivity IOL perform in patients with eye conditions?

Clinical studies show successful outcomes in patients with mild AMD, glaucoma, dry eye, and post-refractive conditions.