Media release –
Alcon receives CE Mark for first-of-its-kind AutonoMe™ preloaded intraocular lens (IOL) delivery system with Clareon® IOL
- AutonoMe™ preloaded IOL delivery system provides easy, intuitive control for precise IOL insertion during cataract surgery
- New Clareon® IOL in vitro data and early clinical experience to be presented at European Society of Cataract & Refractive Surgeons congress
BASEL, Switzerland, October 6, 2017 – Alcon, the global leader in eye care and a division of Novartis, has achieved European CE Mark for the Clareon® IOL with the AutonoMe™ delivery system. AutonoMe™ is the first-and-only automated, disposable, pre-loaded IOL delivery system that enables precise delivery of the IOL into the capsular bag in patients undergoing cataract surgery1-2. The new device is being introduced with the Clareon® IOL, a new BioMaterial with an advanced design that enables sharp, crisp vision; low edge glare; and, unsurpassed optic clarity2*. These new innovations, along with supporting scientific data, will be presented at the XXXV congress of the European Society of Cataract & Refractive Surgeons (ESCRS) taking place October 7 – 11 in Lisbon, Portugal.
“With the introduction of Clareon® AutonoMe™, we are proud to unveil our latest innovations to benefit doctors and their patients undergoing cataract surgery,” said Mike Ball, Chief Executive Officer, Alcon. “Throughout Alcon’s history, we have worked with doctors to enhance and transform the way cataract surgery is performed. Clareon® AutonoMe™ builds upon the comprehensive legacy of AcrySof® by offering cataract surgeons easy, intuitive control of IOL delivery with the newest optic material.”
The AutonoMe™ delivery system, preloaded with the Clareon® IOL, is designed with advancements intended to benefit both surgeons and cataract patients. Its automated CO2-powered delivery mechanism and intuitive, ergonomic design allow precise and simplified single-handed control of IOL placement during cataract surgery1-2.
“Comfort and efficiency during the cataract surgery are key to achieving better outcomes. This new device is expected to improve the procedure and ultimately to reduce surgical time,” said Prof. Rudolph Nuijts, University of Maastricht, Netherlands. “This is great news for surgeons because Clareon® AutonoMe™ provides a cutting-edge, intuitive and easy-to-use device that allows precise and controlled IOL delivery.”
The Clareon® hydrophobic acrylic IOL, which received CE Mark in May, is made of a patented, innovative optic polymer material. Clareon® builds on and maintains the benefits of the proven AcrySof® platform with a new optic BioMaterial that offers cataract patients unsurpassed clarity2*.
Alcon will present new data on Clareon® via paper presentations and electronic posters at ESCRS, including:
- Scientific Paper Presentation: Optical Purity Evaluation and Accelerated Aging of the New Clareon® Biomaterial vs. Other Hydrophobic Acrylic Material in a Laboratory Setup, Dr. G. Auffarth (Tuesday, October 10, 3:42 – 3:48 p.m., Room 3.6, FIL congress center)
- Scientific Paper Presentation: Evaluation of Clarity Characteristics in a New Hydrophobic Acrylic IOL in Comparison with Commercially Available Lenses, Dr. L. Werner, (Tuesday, October 10, 3:48p.m., Room 3.6, FIL congress center)
- Electronic Poster: Model Eye and In Vitro Assessment of Positive Dysphotopsia or Glare Types Photic Phenomena: A Comparison of a New Material IOL to other Monofocal Intraocular Lenses, Dr. L. Werner
- Electronic Poster: Laboratory Evaluation of the New Clareon® Hydrophobic Acrylic IOL Material: Biomaterial Properties and Capsular Bag Behaviour, Dr. G. Auffarth
- Electronic Poster: Miyake-Apple Posterior View analysis of Capsular Bag Behavior of the New Clareon® Hydrophobic Acrylic IOL Material, Dr. H. Fang
- Electronic Poster: Silicone Oil Adhesion of Hydrophobic Acrylic Intraocular Lenses (IOL): A Comparative Laboratory Study of the New Clareon® Versus Current AcrySof® IOL Material, Dr. F. Hengerer
- Electronic Poster: Evaluation of the Mechanical Behavior of a New Single-Piece Intraocular Lens as Compared to Commercially Available IOLs, Dr. S. Lane
Clareon® AutonoMe™ is expected to be commercially available to cataract surgeons in the EU early next year. Learn more about these innovations at the Alcon Booth #P272 in the exhibition area of the Feira Internacional de Lisboa (FIL) congress center at ESCRS.
A cataract is a clouding of the natural lens of the eye that affects vision. As a cataract develops, the eye's lens gradually becomes harder and cloudy which scatters light rays and allows less light to pass through it, thus reducing the patient's ability to see. The vast majority of cataracts occur as part of normal aging but radiation exposure, taking steroids, diabetes, and eye trauma can accelerate the development of cataracts.
Additionally, cataracts can be hereditary and congenital and can present shortly after birth3. Cataracts are the most common age-related eye condition and the leading cause of preventable blindness in adults 55 and older4. Cataracts are treated by surgically removing the eye's cloudy natural lens and replacing it with an intraocular lens (IOL). More than 98 percent of cataract surgeries are considered successful and patients can usually return to their normal routines very soon after surgery5.
Important Information About the Clareon® IOL with the AutonoMe™ Delivery System
As with any surgical procedure, there is risk involved. Potential complications accompanying cataract and/or IOL implantation surgery may include, but are not limited to, the following: lens epithelial cell on-growth, corneal endothelial damage, infection (endophthalmitis), retinal detachment, vitritis, cystoid macular edema, corneal edema, pupillary block, cyclitic membrane, iris prolapse, hypopyon, transient or persistent glaucoma. Surgeons should use careful preoperative evaluation and sound clinical judgement to decide the benefit/risk ratio before implanting a lens in a patient with one or more of the conditions identified in the product labeling. Only Alcon-qualified ophthalmic viscosurgical devices (OVDs) should be used with Clareon® AutonoMe™. The use of an unqualified OVD may cause damage to the lens and potential complications during the implantation process.
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations 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 investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; general economic and industry conditions, including the effects of the persistently weak economic and financial environment in many countries; safety, quality or manufacturing issues, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US 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.
- Clareon® AutonoMe™ IOL Directions for Use.
- Alcon data on file, 2017
- NIH, NEI, Facts About Cataracts, September 2009. Available at: https://nei.nih.gov/health/cataract/ (link is external)
- National Institutes of Health (NIH), National Eye Institute (NEI), Eye Health Needs of Older Adults Literature Review, 2007. Available at: http://www.nei.nih.gov/nehep/research/The_Eye_Health_needs_of_Older_Adults_Literature_Review.pdf (link is external)
- Eye Surgery Education Council, Cataract Surgery, accessed August 2013. Available at: http://eyesurgeryeducation.org/surgery-optionscataract-about.php (link is external)
*Based on aggregate results from in vitro evaluations of haze, SSNGs and glistenings compared to TECNIS§ OptiBlue§ ZCB00V (Abbott),TECNIS§ ZCB00 (Abbott), Eternity§ Natural Uni W-60 (Santen), Vivinex§ XY-1 (HOYA) and enVista§ MX60 (B&L; Bausch & Lomb).
§ Trademarks are the property of their respective owners
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, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of 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. Novartis Group companies employ approximately 119,000 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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Alcon is the global leader in eye care. As a division of Novartis, we offer the broadest portfolio of 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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