Alcon receives European Approval for pre-loaded intraocular lens delivery system to treat patients undergoing cataract surgery
Jul 01, 2015
AcrySof® IQ Aspheric Intraocular Lens (IOL) with UltraSertTM Pre-loaded Delivery System helps to maintain the integrity of the incision while facilitating smooth, consistent delivery of the IOL
Following recent European approval of trifocal presbyopia-correcting IOL, single-use delivery system further expands the Alcon portfolio for cataract surgery
Basel, July 1, 2015- Alcon, the global leader in eye care and a division of Novartis, has received European CE Mark for its AcrySof® IQ Aspheric IOL with the UltraSertTM Pre-loaded Delivery System for patients undergoing cataract surgery. The new delivery system combines the control of a manually loaded device with the safety and convenience of a disposable, pre-loaded injector to optimize implantation of the AcrySof IQ Aspheric IOL. This approval follows the recent CE Mark for Alcon's trifocal presbyopia-correcting AcrySof IOL which was received in mid-June. More than three million cataract surgeries are performed each year in Europe.
"Alcon is committed to advancing cataract surgery through the continuous development of new technologies and processes," said Franck Leveiller, PhD., Alcon Surgical Head of Research & Development. "Every detail of the UltraSert Pre-loaded Delivery System has been engineered with the needs of surgeons, technicians and the outcomes for their patients in mind. By simplifying the device preparation and maximizing surgeon control in a single-use system, we have cleared the path for more streamlined procedures and potentially improved patient outcomes."
In cataract surgery, controlling the rate of delivery of the IOL when inserted into the eye is an important factor in achieving a successful cataract procedure. Alcon has addressed this factor in the UltraSert Pre-loaded Delivery System with the TensionGlideTM Plunger, a spring-controlled mechanism designed for a smooth, controlled delivery of the AcrySof IQ IOL into the capsular bag. In addition, the UltraSert Pre-loaded Delivery System features a plunger tip which is designed to support consistent IOL folding and precise placement of the IOL into the capsular bag of the eye,.
The design of the new UltraSert Pre-loaded Delivery System also helps to create a less invasive corneal incision during cataract surgery. The smaller nozzle tip allows for a corneal incision down to 2.2 mm for insertion of the IOL while the Depth GuardTM nozzle feature of the delivery system prevents the device from being inserted deeper into the incision than necessary, preserving the size of the original corneal incision.
"It is truly a step forward in pre-loaded delivery system technology," said Khiun Tjia, MD, Senior Ophthalmologist, Isala Clinics, Zwolle, Netherlands. "Featuring an impressive array of innovations, the UltraSert System acts as an extension of the surgeon during the critical moment of implantation. It helps to maintain the integrity of the incision while facilitating smooth, consistent delivery of the proven AcrySof IQ Aspheric IOL."
About Cataracts 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 birth. Cataracts are the most common age-related eye condition and the leading cause of preventable blindness in adults 55 and older. 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 within 24 hours.
Important Information about the UltraSert Pre-loaded Delivery System As with any surgical procedure, there is risk involved. Potential complications accompanying cataract or implant surgery may include corneal endothelial damage, endophthalmitis, retinal detachment, vitritis, cystoid macular edema, corneal edema, pupillary block, cyclitic membrane, iris prolapse, hypopyon, and transient or persistent glaucoma. Only Alcon qualified viscoelastic(s) should be used with the UltraSert Pre-loaded Delivery System. The use of an unqualified viscoelastic may cause damage to the lens and potential complications during the implantation process.
Disclaimer The foregoing release contains forward-looking statements that can be identified by words such as "committed," "cleared the path," "potentially," "may," or similar terms, or by express or implied discussions regarding potential additional marketing approvals for the UltraSert Pre-loaded Delivery System, or regarding potential future revenues from the AcrySof IQ Aspheric IOL with UltraSert Pre-loaded Delivery System or other products with the UltraSert Pre-loaded Delivery System. 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 UltraSert Pre-loaded Delivery System 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 Aspheric IOL with UltraSert Pre-loaded Delivery System or other products with the UltraSert Pre-loaded Delivery System will be commercially successful in the future. In particular, management's expectations regarding the AcrySof IQ Aspheric IOL with UltraSert Pre-loaded Delivery System or other products with the UltraSert Pre-loaded Delivery System 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 safety issues; unexpected 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.
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 2014, the Group achieved net sales of USD 58.0 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 120,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit http://www.novartis.com.
References  Market Scope, 2014 Comprehensive Report on The Global IOL Market, May 2014.  UltraSert(TM) Delivery System Prototype Human Factor Testing, February 2015.  AcrySof® IQ UltraSert(TM) Preloaded Delivery System Directions for Use.  Comparative Assessment of IOL Delivery Systems. Alcon internal technical report: TDOC-0018957. Effective Date 19 May 2015.  NIH, NEI, Facts About Cataracts, September 2009. Available at: http://www.nei.nih.gov/health/cataract/cataract_facts.asp  Riley AF, Grupcheva CN, Malik TY, Craig JP, McGhee CN. The Auckland Cataract Study: demographic, corneal topographic and ocular biometric parameters. Clin Experiment Ophthalmol. 2001; 29:381-6.  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  Eye Surgery Education Council, Cataract Surgery, accessed August 2013. Available at: http://eyesurgeryeducation.org/surgery-optionscataract-about.php
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