Vivity, the World’s Leading EDOF IOL, Reaches One Million Milestone
Alcon celebrates surpassing one million implants of AcrySof IQ Vivity and Clareon Vivity extended depth of focus intraocular lenses globally. Vivity, with its patented wavefront-shaping technology, offers excellent outcomes for cataract patients, addressing presbyopia and expanding patient candidacy pool.
From a clinical perspective, the surpassing of one million implants of the Vivity intraocular lens (IOL) represents a significant milestone in the field of ophthalmology. The patented Wavefront-Shaping X-WAVE™ technology used in Vivity lenses is a noteworthy advancement in presbyopia-correcting IOLs (PCIOLs). Unlike traditional diffractive lenses, which can cause dysphotopsias such as haloes and glare, the non-diffractive mechanism of Vivity stretches and shifts light, thus reducing visual disturbances and potentially enhancing patient satisfaction.
Furthermore, the ability of Vivity lenses to provide high quality vision across a range of distances is particularly beneficial for cataract patients, who often seek independence from glasses post-surgery. The inclusion of patients with common ocular comorbidities in the Vivity Registry Study indicates the lens's versatility and potential suitability for a broader patient population.
The achievement of one million implants for Vivity lenses by Alcon signifies not only a clinical success but also a strategic market penetration. Alcon's position as a global leader in IOLs is further solidified by this milestone, which may positively influence investor confidence and the company's stock performance. The broad geographical availability of Vivity in over 80 countries showcases Alcon's extensive distribution capabilities and its commitment to addressing a diverse range of vision needs, potentially leading to increased global market share.
The data indicating high patient satisfaction rates and low incidence of visual disturbances could enhance the brand's reputation and drive demand for Vivity among surgeons and patients. This is especially relevant as the aging population grows and the prevalence of cataracts increases, expanding the potential customer base for Alcon's IOL products.
Alcon's Vivity IOL reaching over one million implants is a testament to the regulatory success of the device. The patented technology and the ability to cater to patients with mild comorbidities suggest that Vivity has met rigorous safety and efficacy standards set by various health authorities. This accomplishment may facilitate smoother regulatory pathways for future Alcon products, as established safety profiles can positively influence regulatory bodies' perceptions.
Additionally, the extensive international availability of Vivity implies a comprehensive understanding of and compliance with diverse regulatory environments. The real-world data from the Vivity Registry Study could be instrumental in supporting post-market surveillance and continuous quality improvement, which are critical aspects of medical device regulation.
03/06/2024 - 08:00 AM
Vivity is the most implanted extended depth of focus (EDOF) intraocular lens (IOL) globally 1
Milestone underscores the impact of Vivity’s first-of-its-kind, patented wavefront-shaping technology, which simplifies presbyopia correction for surgeons and patients 2,3
Vivity demonstrates excellent outcomes, with real-world Vivity Registry data from more than 900 cataract patients, including patients with certain mild comorbidities as well as post-refractive eyes 4
FORT WORTH, Texas --(BUSINESS WIRE)--
Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today proudly announces AcrySof® IQ Vivity® and Clareon® Vivity extended depth of focus (EDOF) intraocular lenses (IOLs) have surpassed more than one million implants worldwide. Vivity is the most implanted EDOF IOL globally.1* Alcon is the global leader in IOLs—every four seconds an eye is implanted with an Alcon IOL—and continues to innovate in this space to address patients’ unmet needs.5
“We are proud to celebrate the one million Vivity eyes empowering cataract patients to see the world with high quality vision from distance to functional near—day and night,” said Sean Clark, President, Global Surgical Franchise at Alcon. “This milestone embodies our commitment to addressing the diverse vision needs of today's patients, who desire less dependence on glasses post-surgery and low visual disturbances, with a game-changing presbyopia-correcting intraocular lens (PCIOL) option that expands the patient candidacy pool.”
Vivity uses Alcon’s patented non-diffractive Wavefront-Shaping X-WAVE™ technology, an advanced optical principle that simultaneously stretches and shifts light without splitting it—balancing quality of vision and maximizing range of vision.2,3 The optic delivers excellent distance and intermediate vision, as well as functional near vision.2 The unique mechanism of action is not refractive, does not introduce spherical aberrations and has ultimately expanded PCIOL access to even more patients. Vivity is designed to simplify presbyopia correction, prioritizing patient satisfaction while minimizing surgeon and clinic chair time.
Recent, large-scale real-world data underscores the impact of Vivity on patients across the globe. The Vivity Registry Study4+ includes patients with common mild comorbidities like glaucoma, dry eye and retinopathy/maculopathy, as well as post-refractive eyes. The Registry data demonstrates high patient satisfaction among several patient cohorts, as the vast majority of patients (92% ) report they are satisfied with their sight.∞ Additionally, more than 91% of patients report no haloes, glares, or starbursts.†
Vivity is available in more than 80 countries, including Australia , Brazil , Canada , China , France , Germany , Japan , India , Italy , Russia , South Korea , Spain , U.K. and U.S. Alcon offers a family of leading IOLs designed to meet the unique vision needs of patients, including Vivity and PanOptix® —the most implanted PCIOLs worldwide—as well as monofocal and toric options. PanOptix surpassed one million implants in early 2022, and is the most implanted trifocal worldwide.5,6 For more information, please visit www.ClareonIOL.com .
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. 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.
About PanOptix
The AcrySof® IQ PanOptix® Trifocal IOL and the Clareon® PanOptix® Trifocal IOL are types of multifocal IOLs used to focus images clearly onto the back of your eye (retina) to allow clear vision after the cataract removal. In addition, the center of the PanOptix® Trifocal IOL allows for better near (reading) vision and intermediate (computer work) vision versus what a monofocal lens would provide.
Potential side effects: Due to the design of multifocal IOLs, there are some side effects that can be associated with the AcrySof® IQ and Clareon® PanOptix® Trifocal IOL models. These may be worse than with a monofocal IOL, including visual disturbances, such as glare, rings around lights, starbursts (rays around light sources), and reduced contrast sensitivity (decrease in ability to distinguish objects from their background, especially in dim lighting). These side effects may make it more difficult to see while driving at night or completing tasks in low lighting conditions such as at night or in fog or in a dimly lit room after surgery as compared to before surgery.
Further, a toric IOL corrects astigmatism only when it is placed in the correct position in the eye. There is a possibility that the toric IOL could be placed incorrectly or could move within the eye. If the toric lens is not positioned correctly following surgery, the change in your astigmatism correction by the IOL, along with any necessary correction with glasses, may cause visual distortions. If the lens rotates in your eye, you may need additional surgery to reposition or replace the IOL.
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 .
References
Market Scope - 2023 Premium Cataract Surgery Market Report; 2023 IOL Market Report.
Alcon Data on File; U.S. Pat. Nos. RE45,969, 9,968,440, 11,083,566.
AcrySof® IQ Vivity® or Clareon® Vivity® IOL Directions for Use.
Reus NJ, Kooijman M, Perez-Vives C. Overall Visual Outcomes from a Real-world Study of Presbyopia-correcting IOLs in a Large Population. Presented at the European Society of Cataract and Refractive Surgery (ESCRS) Annual Meeting; 8-12 Sept. 2023; Vienna, Austria .
Alcon Data on File, 2024. REF-22137.
Alcon IOL Global Sales; Jan. 2021-Nov. 2022.
* Based on independent market audit - Market Scope - 2023 Premium Cataract Surgery Market Report.
+ The Vivity® Registry Study was a multicentre, ambispective, non-comparative, open-label, non-interventional registry study conducted across 41 sites from eight (8) countries: Australia , Belgium , Germany , New Zealand , the Netherlands , Portugal , Spain and the United Kingdom .
∞ Subject satisfaction was evaluated with the Catquest 9SF Questionnaire. Statistic refers to ‘very’ or ‘fairly’ satisfied.
† Visual disturbances were evaluated by asking open, non-prompted questions about visual experience.
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Source: Alcon Inc. Investors
How many implants of AcrySof IQ Vivity and Clareon Vivity extended depth of focus intraocular lenses have been surpassed globally?
Alcon has surpassed more than one million implants of AcrySof IQ Vivity and Clareon Vivity extended depth of focus intraocular lenses globally.
What technology does Vivity use for presbyopia correction?
Vivity uses Alcon's patented non-diffractive Wavefront-Shaping X-WAVE technology for presbyopia correction.
What percentage of patients report satisfaction with their sight after using Vivity?
More than 92% of patients report satisfaction with their sight after using Vivity.
In how many countries is Vivity available?
Vivity is available in more than 80 countries worldwide.
Which other intraocular lenses are offered by Alcon?
Alcon offers a family of leading IOLs including Vivity, PanOptix, monofocal, and toric options.
