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2015-11-15 18:00 CET
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Alcon introduces Contoura Vision as first personalized LASIK procedure at American Academy of Ophthalmology Annual Meeting

  • Nearly 65% of eyes treated with personalized topography-guided LASIK experienced 20/16 vision or better[1] in clinical study
     
  • Alcon is the first refractive laser manufacturer to receive FDA approval for a topography-guided LASIK procedure  
     
  • Alcon to further showcase new data in glaucoma treatments, cataract as well as refractive surgery procedures using Wavelight technology

             
Basel, November 15, 2015 - Alcon, the global leader in eye care and a division of Novartis, will introduce Contoura Vision, the latest advancement in its WaveLight refractive portfolio during the annual meeting of the American Academy of Ophthalmology (AAO) in Las Vegas, November 14-17, 2015. Alcon will also present new research findings in glaucoma, cataract and refractive surgical procedures at AAO.

Building on its broad portfolio of ophthalmic surgical innovations, Contoura Vision is a topography-guided LASIK treatment designed to provide surgeons the ability to perform more personalized laser procedures for patients with nearsightedness, or nearsightedness with astigmatism, based on the unique corneal topography of each eye. In 2014, more than 630,000 LASIK procedures were performed in the US alone.[2]

"We are pleased to provide surgeons with a technology that has been shown to deliver visual acuity better than glasses or contact lenses for nearly one-third of patient eyes in a clinical trial setting," said Franck Leveiller, Head of Research & Development for Alcon's Surgical Franchise. "Backed by FDA approval and very positive clinical trial outcomes, surgeons can now offer a topography-guided treatment option for refractive surgery patients in the US."

Multicenter clinical trial results demonstrate that the personalized topography-guided LASIK procedure Contoura Vision redefined the standard practice terminology of "quality of vision" which is visual acuity combined with visual symptoms, with more than 30% of eyes achieving better unaided visual acuity 12 months after surgery than with glasses or contact lenses prior to surgery.[1] In this US-based clinical trial, 92.6% of eyes that received topography-guided LASIK treatment achieved 20/20 vision or better: specifically, 64.8% experienced 20/16 vision or better, and 34.4% could see 20/12.5 or better, 12 months after surgery. The procedure also showed statistically significant reductions in some of the visual symptoms associated with LASIK, such as glare, light sensitivity, difficulty driving at night and difficulty while reading.

Contoura Vision is performed with Alcon's WaveLight Allegretto Wave Eye-Q or WaveLight EX500 Excimer Laser Systems, in conjunction with the WaveLight Topolyzer Vario Diagnostic Device. Alcon plans for broad commercial release of Contoura Vision in in the US in early 2016.

Alcon Scientific Results and Data Presentations during AAO
In addition to its Contoura Vision launch, Alcon will be presenting data and clinical results for current pipeline and product innovations:

  • Two Studies on Fixed Combination Brinzolamide 1%/Brimonidine 0.2% (BBFC) used Adjunctive to Prostaglandin Analogs (PGAs): Findings show additive effect of BBFC therapy in patients with open-angle glaucoma or ocular hypertension who were inadequately controlled on PGA alone.
  • A Study Comparing Intraoperative Aberrometry versus a Toric Calculator in Determining Toric IOL Cylinder Power and Axis
  • Refractive Outcomes in Post-hyperoptic LASIK Cataract Patients in which Intraoperative Aberrometry was used to Determine IOL Power
  • Postoperative Uncorrected Visual Acuity vs Preoperative Best Corrected Visual Acuity with the WaveLight Refractive Suite
  • Comparing Aphakic Refractive Measurements in Eyes in which BSS and an ophthalmic viscosurgical device were used with an Intraoperative Aberrometer

For further details about Alcon presentations and poster sessions, please visit the AAO meeting program schedule https://secure.aao.org/apps/.

Important Information about WaveLight Excimer Lasers
WaveLight Excimer Lasers are prescription medical devices that are approved for use in performing laser-assisted in-situ keratomileusis (LASIK) to correct certain kinds of nearsightedness (myopia), farsightedness (hyperopia), and astigmatism. Only doctors who have been trained in laser refractive surgery (including laser calibration and operation) should use a WaveLight Excimer Laser.

Patients should not undergo LASIK surgery if they are pregnant or nursing; if they have a collagen vascular, autoimmune or immunodeficiency disease; if they show signs of keratoconus or any other condition that causes a thinning of the cornea; or if they are taking isotretinoin (Accutane*) or amiodarone hydrochloride (Cordarone*). The most common risks of LASIK vision correction surgery with refractive lasers include dry eye syndrome; the possible need for glasses or contact lenses after surgery; visual symptoms including halos, glare, starbursts, and double vision; and loss of vision. Additional product information can be found on the Laser website at www.alconsurgical.com.

*Trademarks are property of their respective owners.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as "will," "scheduled," "portfolio," "plans," "promising," "pipeline," or similar terms, or by express or implied discussions regarding potential future marketing approvals for Contoura Vision or the other Alcon pipeline projects discussed in this release, or regarding potential future revenues from Contoura Vision or the portfolio of Alcon pipeline projects and marketed products discussed in this release. 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 Contoura Vision or the other Alcon pipeline projects discussed in this release will be submitted or approved for sale in any additional markets, or at any particular time. Nor can there be any guarantee that Contoura Vision or the portfolio of Alcon pipeline projects and marketed products discussed in this release will be commercially successful in the future. In particular, management's expectations regarding Contoura Vision and the portfolio of Alcon pipeline projects and marketed products discussed in this release could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; 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 or quality 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.

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References
[1] FDA Clinical Trials. Allegretto Wave Eye-Q Addendum Procedure Manual T-CAT Topography-Guided Treatments. http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020050S012d.pdf
[2] MarketScope. Alcon data on file, 2015.

* Post hoc analysis of postoperative UCVA compared to preoperative BSCVA of 230 eyes contained in the FDA T-CAT pivotal trial at 12 months. The primary end point evaluated changes in BSCVA

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