Alcon Completes Availability of Clareon Portfolio with Clareon Toric During AAO 2022

FORT WORTH, Texas--(BUSINESS WIRE)--Sep 29, 2022--

Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, announced today new product launches in the U.S. as well as activities taking place at the upcoming American Academy of Ophthalmology (AAO) 2022 annual meeting in Chicago.

Alcon introduces Clareon Toric IOL at AAO and completes the Clareon Collection
With the introduction of Clareon ® Toric intraocular lens (IOL), Alcon offers a robust portfolio of options for U.S. cataract patients with astigmatism on its latest, glistening-free * material. 1-3 Clareon Toric features unique and proven STABLEFORCE ® Haptics technology, with demonstrated superior rotational and axial stability when compared to TECNIS † and enVista. 4,5†**

Clareon Toric and Clareon Monofocal consistently deliver a broad refractive landing zone, providing functional intermediate vision while maintaining the expected 20/20 visual acuity at distance. 6-8 The Clareon Collection of IOLs is now complete and 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 the U.S.

“When deciding which lens to recommend to my patients, I like to have a toolbox of versatile options that provide consistent, predictable outcomes—and the Clareon Collection of IOLs offers exactly that,” said Kerry Solomon, MD. § “Now, with the availability of Clareon Toric, I am able to offer my patients a glistening-free,* astigmatism-correcting option for them during surgery.”

Expanding Alcon’s digital offerings with Fidelis, and patient engagement
Fidelis™ Virtual Reality Ophthalmic Surgical Simulator, which was introduced in select markets in May, is now available for pre-order for customers in the U.S. Fidelis offers a high-fidelity, virtual operating room environment with haptic feedback to simulate the look and feel of cataract surgery, helping new surgeons hone their skills. 9,10

“Partnering with ophthalmologists to develop world-class solutions that help drive optimal outcomes is in our DNA—and we would not be able to deliver digital innovations without these trusted relationships,” said Sergio Duplan, Region President Alcon North America. “At AAO, we are proud to showcase our cloud-based connected technologies with ARGOS ®, the fastest growing biometer in the U.S., as well as other key offerings like a text-driven patient engagement tool with demonstrable ROI for ophthalmology practices.” 11,12

The need for remote, digital solutions in ophthalmology has never been greater, given worldwide surgery backlogs and staffing shortages. Alcon is committed to shaping digital transformation in ophthalmology. In addition to the opportunity to demo Fidelis, surgeons will be able to experience and sign up for a resource that educates cataract patients about surgery and advanced technology IOL options via SMS text. These activities will take place at Alcon booth #3926 at the AAO exhibit hall, on Oct. 1-3 from 9:00 a.m.–5:00 p.m. Central Time.

Data highlight benefits of Alcon surgical ophthalmic products
Key studies being presented on Alcon products include:

• Global registry data in more than 750 patients surrounding AcrySof ® IQ Vivity ® IOL supports continued patient satisfaction, low instances of visual disturbances and reduced spectacle dependence. 13
• Results from a multicenter, prospective clinical trial demonstrates energy and surgical time savings when using the CENTURION ® phacoemulsification system with Active Sentry ®. 14
• A novel retina imaging technique using the NGENUITY ® 3D Visualization System unveiled by surgeons seeking to develop more efficient methods for fluorescein angiography. 15
• A clinical study of 500 eyes comparing results of CONTOURA ® Laser Vision Correction with Phorcides Analytic Engine in low versus high myopia. 16

To learn more about Alcon news, events and data taking place during AAO, please visit MyAlconatAAO.com.

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 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.

About ARGOS ® Biometer with Image Guidance
ARGOS is a non-invasive, non-contact biometer based on swept source optical coherence tomography (SS-OCT). The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraocular lens placement. Please refer to the ARGOS User Manual for a complete description of proper use and maintenance, optical and technical specifications, as well as a complete list of warnings and precautions.

About AcrySof ® IQ Vivity ® IOL
The non-diffractive AcrySof ® IQ Vivity ® Extended Vision Posterior Chamber Intraocular Lens Model DFT015 (referred to as AcrySof ® IQ Vivity ® IOL) is a UV-absorbing and blue light-filtering foldable intraocular lens (IOL). This IOL, compared to a monofocal IOL, provides an extended range of vision from distance to near without increasing the incidence 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. 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 (such as IOL replacement implanted by a different one or surgery to improve vision) after the implantation of the initial IOL.

About CENTURION ® Vision System
The CENTURION ® Vision System is indicated for emulsification, separation, irrigation, and aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intraocular lens injection. Appropriate use of CENTURION ® Vision System parameters and accessories is important for successful procedures. Please refer to the ORA SYSTEM ® Operator’s Manual for a complete description of proper use and maintenance, as well as a complete list of contraindications, warnings and precautions.

About NGENUITY ® 3D Visualization System
The NGENUITY 3D Visualization System consists of a 3D stereoscopic, high-definition digital video camera and workstation to provide magnified stereoscopic images of objects during micro-surgery. It acts as an adjunct to the surgical microscope during surgery displaying real-time images or images from recordings. Please refer to the User Manual for a complete list of appropriate uses, 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.

* Defined as modified Miyata grade 0, <25mv/mm2over 3 years (n=138), and over 9 years (n=20), respectively.
** Compared in vitro with enVista † and TECNIS † (n=10 lenses per group, P<0.05).
† Trademarks are the property of their respective owners.
§ Dr. Solomon is a paid Alcon consultant.

References

1. Werner L, Thatthamla I, Ong M, et al. Evaluation of clarity characteristics in a new hydrophobic acrylic IOL. J Cataract RefractSurg. 2019;45:1490-1497.
2. 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.
3. 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.
4. Alcon Data on File, 2017.
5. Lane S, Collins S, Das KK, Maass S, Thatthamla I, Schatz H, Van Noy S, Jain R. Evaluation of intraocular lens mechanical stability. J Cataract Refract Surg. 2019 Apr;45(4):501-506.
6. Clareon ® Vivity ® Toric Directions for Use.
7. Bala C, Poyales F, Guarro M, et al. Multi-country clinical outcomes of a new nondiffractive presybopia-correcting intraocular lens. Journal of Cataract and refractive surgery published ahead of print DOI: 10.1097/j.jcrs.0000000000000712.
8. Varma, Devesh, et. al. Clinical outcomes of a new non-diffractive presbyopia-correcting intraocular lens from two large confirmatory studies. American Academy of Ophthalmology. Abstract: PA005.
9. Skou Thomsen A, Bach-Holm D, Kjaerbo H, et al. Operating Room Performance Improves After Proficiency-Based Virtual Reality Cataract Surgery Training. National Institute of Health. 2017 April. Doi: 10.1016/j.ophtha.2016.11.015.Epub 2016 Dec 22. PMID: 28017423. Available at: https://pubmed.ncbi.nlm.nih.gov/28017423/.
10. Alcon Data on File, 2022.
11. Alcon Data on File, 2022.
12. Alcon Data on File, 2022.
13. Srinivasan, Sathish, MBB. Patient-Reported outcomes and Visual Performance From Real-World Registry Study With a Novel Wavefront-Shaping EDOF IOL. AAO, Chicago, IL. 1 October 2022.
14. Brézin, Antoine, MD. Evaluation of a Phacoemulsification Handpiece With A Built-in Fluidics Pressure Sensor: The SASCA Multicenter Study. AAO, Chicago, IL. 1 October 2022.
15. Franklin, Alan, MD. FA-Enhanced Visualization During Vitrectomy for Retinal Vascular Disease. AAO, Chicago, IL. 1 October 2022.
16. Shah, Nita, MBBS. Clinical Study of 500 Eyes Comparing Results with Contoura Laser Vision Correction (LVC) with Phorcides Analytic Engine in Low versus High Myopia. AAO, Chicago, IL. 1 October 2022.

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