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Media Release

Alcon announces EU launch of CyPass® Micro-Stent, a micro invasive glaucoma surgical device, to lower intraocular pressure (IOP) in patients with primary open-angle glaucoma

  • Now available in the UK, Germany, Italy and Spain, CyPass Micro-Stent is designed to significantly reduce intraocular pressure (IOP)
  • CE indication has been expanded to allow patients to be treated at the time of cataract surgery without the requirement of failed medical therapy  
  • More than 60 million people worldwide are affected by glaucoma, the leading cause of irreversible blindness worldwide1,2 3

 

BASEL, April 26, 2017 – Alcon, the global leader in eye care and a division of Novartis, announced today the EU launch of the CyPass® Micro-Stent, a micro invasive glaucoma surgical (MIGS) device, indicated for the treatment of patients with mild to moderate primary open-angle glaucoma in conjunction with cataract surgery, or as a standalone procedure in patients with primary open-angle glaucoma who have failed previous medical treatments. The CyPass Micro-Stent is the latest addition to Alcon's surgical glaucoma portfolio providing an additional option to meet the needs of millions of glaucoma patients.

“For many glaucoma patients, medication adherence can be challenging due to side effects, difficulty administering drops and the number of medications required daily. Even with proper compliance, patients often have disease progression and require surgery,” said Keith Barton, M.D., glaucoma specialist at Moorfields Eye Hospital in London. “The CyPass Micro-Stent is a much-needed new option that is less invasive than traditional glaucoma surgery. More importantly, it is available to patients with mild to moderate glaucoma who are undergoing cataract surgery, even if they have not yet failed previous medical treatments for their glaucoma.”

The CyPass Micro-Stent, implanted just below the surface of the eye, is uniquely designed to reduce intraocular pressure (IOP) in patients with primary open-angle glaucoma. The CyPass Micro-Stent is the first MIGS device to leverage an entirely new outflow pathway for excess aqueous fluid in the eye – the supraciliary space, which is the space between the sclera, the white outer layer of the eyeball, and the ciliary body. Once implanted, it creates a permanent conduit between the anterior chamber of the eye and the suprachoroidal space to improve the eye’s natural drainage pathway.

“The CyPass Micro-Stent is designed to address the greatest unmet need in glaucoma treatment, reducing patient burden by lowering dependence on topical glaucoma medicine,” said Ian Bell, Region President, Europe, Middle East and Africa for Alcon. “We’re pleased to offer the CyPass Micro-Stent as a valuable new surgical treatment option for providers and patients in four EU countries, further expanding Alcon’s leadership in glaucoma and surgical ophthalmology.”

The CyPass Micro-Stent is now available in the UK, Germany, Italy and Spain. Alcon launched the CyPass Micro-Stent in the US last October and plans to train and certify over 500 surgeons in 2017.

About Glaucoma 
More than 60 million people globally are affected by glaucoma that can lead to progressive damage of the optic nerve. Early diagnosis of glaucoma is critical to manage the disease, as it is often asymptomatic and therefore can go undetected until it is at an advanced stage. As the disease progresses, patients may experience loss of peripheral (side) vision, tunnel vision or eye spots. Glaucoma can eventually result in gradual, irreversible loss of vision and blindness. The exact cause of glaucoma is unknown. However, elevated pressure in the eye (intraocular pressure, or IOP) is generally present with glaucoma and is the only known modifiable risk factor. As a chronic disease, patients can be treated with eye drops, oral medications, laser surgery, traditional surgery or a combination of these methods1,2,4.

About the CyPass Micro-Stent 
The CyPass Micro-Stent is a prescription medical device that is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma, or for use in cataract surgery or as a standalone procedure for the reduction of IOP in adult patients with primary open-angle glaucoma where previous medical treatments have failed.  Use of the CyPass® Micro-Stent is contraindicated in eyes with angle closure glaucoma, in eyes with traumatic, malignant, uveitic or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle and in patients with known intolerance or hypersensitivity to topical anesthetics, miotics, mydriatics or polyimide. The surgeon should monitor the patient postoperatively for proper maintenance of IOP.  If IOP is not adequately maintained after implantation of a CyPass Micro-Stent, additional therapy may be needed for IOP control. 

Please refer to the Instructions for Use for the CyPass Micro-Stent for a complete list of contraindications, warnings, and precautions. 

 

Disclaimer

The foregoing release contains forward-looking statements that can be identified by words such as “launch,” "portfolio," "offer," “plans,” “can,” "may,"  or similar terms, or by express or implied discussions regarding potential additional approvals for the CyPass Micro-Stent, or regarding potential future revenues from CyPass Micro-Stent. 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 CyPass Micro-Stent will be submitted or approved for sale in any additional markets, or at any particular time. Nor can there be any guarantee that CyPass Micro-Stent will be commercially successful in the future. In particular, management's expectations regarding CyPass Micro-Stent 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; 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 and reimbursement pressures; 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.

 

References

  1. Lighthouse International. Prevalence of Vision Impairment. http://www.lighthouse.org/research/statistics-on-vision-impairment/prevalence-of-vision-impairment/ (link is external).
  2. Quigley and Broman. The Number of People with Glaucoma Worldwide in 2010 and 2020. Br J Ophthalmol 2006;90:262-7.
  3. Richter and Coleman. Minimally invasive glaucoma surgery: current status and future prospects. Clin Ophthalmol. 2016; 10: 189–206. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4734795/
  4. http://myeyes.com/glaucoma.shtml (link is external)

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 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 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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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.

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