- Innovative AcrySof ® IQ PanOptix ® Toric i ntraocular lens (IOL) extends Alcon's trifocal PanOptix ® IOL portfolio to a wider range of patients
- CE-marked in November 2016, this IOL offers excellent near-to-intermediate vision, and increased independence from glasses while addressing astigmatism
- More than 70 percent of patients worldwide undergoing cataract surgery have treatable levels of astigmatism[1]
BASEL, Switzerland, January 26, 2017 - Alcon, the global leader in eye care and a division of Novartis, announces the launch of AcrySof ® IQ PanOptix ® Toric presbyopia- and astigmatism-correcting intraocular lens (IOL) for patients with pre-existing corneal astigmatism undergoing cataract surgery. It is a new option for astigmatic patients who seek to address their near, intermediate and distance vision needs with a single lens.
This new lens achieved CE Mark status in November 2016, and was recently launched in Spain, Portugal and Chile. It extends the PanOptix trifocal platform that was first launched at the September 2015 European Society of Cataract and Refractive Surgeons meeting in Barcelona.
"The launch of the AcrySof IQ PanOptix Toric intraocular lens is a significant step forward in Alcon's presbyopia-correcting portfolio and extends our reach into the presbyopic population," said Mike Ball, CEO and Division Head, Alcon. "This lens not only expands available options physicians have to provide value to their patients with astigmatism, it gives patients the visual clarity and increased independence to improve their current lifestyles. For the surgeon, it also allows them to treat astigmatism at the same time as presbyopia with a trifocal that is part of the market-leading AcrySof platform."
The new AcrySof IQ PanOptix Toric IOL is intended for primary implantation in the capsular bag of the posterior chamber of the human eye for the visual correction of aphakia and pre-existing corneal astigmatism secondary to removal of a cataractous lens or clear lens. It is indicated for adult patients with and without presbyopia undergoing cataract surgery who desire near, intermediate and distance vision with increased spectacle independence. It utilizes the same trifocal optic as the AcrySof IQ PanOptix IOL on the front surface of the lens and combines it with the astigmatic correction features of a toric IOL on the back surface. This is the only IOL that delivers an intermediate focal point at 60 cm, a distance preferred by many patients for intermediate vision activities, combined with the exceptional rotational and axial stability of the AcrySof single piece design.
"Without innovations like this, many of my patients undergoing cataract surgery still need to rely on glasses or contact lenses to correct near vision issues or astigmatism post-surgery," said Dr. Thomas Kohnen, Professor and Chairman of the Department of Ophthalmology, Goethe-University Frankfurt. "The availability of vision correction options like the AcrySof IQ PanOptix Toric IOL helps them get back to driving, reading books and using electronic devices without contacts or eyeglasses with tolerable side effects in comparison with previous technologies."
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 happen as a result of normal aging but radiation exposure, taking steroids, diabetes, and eye trauma can accelerate the development of cataracts[2]. Cataracts are the most common age-related eye condition and the leading cause of preventable blindness[3]. Twenty million people in the U.S. age 40 and older have cataracts[4]. Cataracts are treated by removing the eye's cloudy natural lens and surgically replacing it with an intraocular lens or IOL. More than 98 percent of cataract surgeries are considered successful and patients typically can return to their normal routines within 24 hours[5].
About Astigmatism and Presbyopia Astigmatism is a variation in the shape or curvature of the cornea and, if left untreated, can cause blurred vision at all distances. Presbyopia is an eye condition that occurs as part of natural aging. It involves the gradual loss of the eye's ability to actively focus on close objects, such as smart phones, computers, books and menus. The first signs of presbyopia are eyestrain, difficulty seeing in dim light and problems focusing on small objects and/or fine print. Once a person is in their 40s, it is likely they will experience presbyopia and will require vision correction such as reading glasses or multifocal contact lenses.
Important Information about AcrySof PanOptix Toric IOLs As with any surgical procedure, there are associated risks. Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens of this type. This is particularly so in a patient with any of the conditions described in the AcrySof IQ PanOptix Toric IOL physician labeling.
The AcrySof IQ PanOptix Toric IOL corrects corneal astigmatism only when it is placed in the correct position in the eye. There is a possibility that the IOL could be placed incorrectly or could move within the eye. This may result in less improvement or a reduction in vision because your corneal astigmatism has not been fully corrected, or it may cause visual symptoms.
Some patients may experience visual disturbances and/or difficulty seeing due to the multifocal lens design, especially under dim light conditions. As with other multifocal IOLs, visual symptoms may be significant enough that the patient will request explanation of an AcrySof IQ PanOptix Toric IOL. Posterior capsule opacification (PCO) may significantly affect the vision of patients with multifocal IOLs sooner in its progression than in patients with monofocal IOLs.
Disclaimer The foregoing release contains forward-looking statements that can be identified by words such as "should," "expected," "will" or similar terms, or by express or implied discussions regarding potential additional marketing approvals for the AcrySof IQ PanOptix Toric Intraocular Lens, or regarding potential future revenues from the AcrySof IQ PanOptix Toric Intraocular Lens. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the AcrySof IQ PanOptix Toric Intraocular Lens will be submitted or approved for sale in any additional markets, or at any particular time. Nor can there be any guarantee that the AcrySof IQ PanOptix Toric Intraocular Lens will be commercially successful in the future. In particular, management's expectations regarding the AcrySof IQ PanOptix Toric Intraocular Lens could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues; and, other risks and factors referred to in Novartis AG's current Form 20-F on file with the U.S. Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Alcon Alcon is the global leader in eye care. As a division of Novartis, we offer the broadest portfolio of medical device products to enhance sight and improve people's lives. Our products touch the lives of more than 260 million people each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors, and there are millions more who are waiting for solutions to meet their eye care needs. Our purpose is reimagining eye care, and we do this through innovative products, partnerships with eye care professionals and programs that enhance access to quality eye care. Learn more at www.alcon.com .
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About Novartis Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2016, the Group achieved net sales of USD 48.5 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion (USD 8.4 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com .
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References [1] Provided courtesy of Dr. Warren Hill. Accessed January 2017. Available at: http://www.doctor-hill.com/iol-main/astigmatism_chart.htm . [2] American Optometric Association (AOA). Causes of Cataract . Accessed August 2015. Available at: http://www.aoa.org/patients-and-public/eye-an...ract?sso=y [3] World Health Organization (WHO). Causes of Blindness and Visual Impairment: Cataract . Accessed May 2016. Available at: http://www.who.int/blindness/causes/en [4] Centers for Disease Control and Prevention (CDC). Common Eye Disorders. Accessed August 2015. Available at: http://www.cdc.gov/visionhealth/basics/ced/index.html [5] Cleveland Clinic. Cataracts. Accessed August 2015. Available at: http://my.clevelandclinic.org/services/cole-e...-cataracts
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