Alcon announces voluntary global market withdrawal of CyPass Micro-Stent for surgical glaucoma
Decision based on five-year data from COMPASS-XT long-term safety study
Customers located outside the U.S. should contact their local Alcon representative.
Disclaimer
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 "advises," "commitment," "recommendation," "believe," "intend," "would," "will," or similar terms, or by express or implied discussions regarding the potential outcome of the market withdrawal of CyPass Micro-Stent, including the potential financial or other impact of the market withdrawal on Novartis or Alcon, or regarding the potential reintroduction of the product in the future. 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 as to the outcome of the market withdrawal of CyPass Micro-Stent.? Nor can there be any guarantee as to the financial or other impact on Novartis or Alcon as a result of the market withdrawal.? Neither can there be any guarantee that Alcon will be able to reintroduce the product to the market in the future.? In particular, our expectations regarding such products could be affected by, among other things, regulatory actions or delays or government regulation generally; uncertainties relating to the market withdrawal process; unexpected inabilities to satisfy regulators' requirements for the market withdrawal or for any potential reintroduction of the product to the market in the future; the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; safety, quality or manufacturing issues; the potential impact of the market withdrawal on the proposed spinoff of Alcon by Novartis; uncertainties involved in the development or adoption of potentially transformational technologies and business models; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation and government investigations generally, 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?Alcon?
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.
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, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 125,000 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] Reuschel, A., et al., Comparison of endothelial changes and power settings between torsional and longitudinal phacoemulsification. J Cataract Refract Surg, 2010. 36(11): p. 1855-61.
[2] Buys, Y.M., et al., Prospective randomized comparison of one- versus two-site Phacotrabeculectomy two-year results. Ophthalmology, 2008. 115(7): p. 1130-1133 e1.
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail:?investor.relations@novartis.com
- Alcon advises ophthalmic surgeons to cease further implantation
Customer Services | +1 800 862 5266?for assistance with product returns |
Medical Information | +1 800 757 9785?for medical information on the?CyPass Micro-Stent |
Medical Safety | +1 800 757 9780?to report product complaints or adverse events |
# # #
Novartis Media Relations Central media line: +41 61 324 2200 E-mail:?media.relations@novartis.comPaul Barrett Novartis Global External Communications +41 61 324 5224 (direct) +41 79 797 8137 (mobile) paul.barett@novartis.com | Antonio Ligi Novartis Global External Communications +41 61 324 1374 (office) +41 79 723 3681 (mobile) antonio.ligi@novartis.com |
Eric Althoff Novartis Global External Communications +41 61 324 7999 (office) +41 79 593 4202 (mobile) eric.althoff@novartis.com | Wes Warnock Alcon Global Communications +1 817 615 2501 (office) +1 210 240 4998 (mobile) wes.warnock@alcon.com |
Central | North America | ||
Samir Shah | +41 61 324 7944 | Richard Pulik | +1 212 830 2448 |
Pierre-Michel Bringer | +41 61 324 1065 | Cory Twining | +1 212 830 2417 |
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Isabella Zinck | +41 61 324 7188 |