Alcon launches new IOL in U.S.

Alcon today announced the launch of the Clareon family of IOLs in the U.S.

According to a company news release, by using what is described as an “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.”

According to the company, its 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’ Stableforce haptics provide superior axial and rotational stability.*,^β,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 Samuel H. Lee, MD, Ophthalmologist, Sacramento, California. “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.1^3,18

According to a news release, the company noted that 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

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.