Alcon achieves US approval for CyPass® Micro-Stent, a micro invasive surgical device to treat glaucoma

• US Food and Drug Administration (FDA) grants approval for CyPass Micro-Stent for sale in the US, expanding Alcon's surgical presence to treat glaucoma
   
• The CyPass Micro-Stent is designed to reduce intraocular pressure in patients with mild to moderate primary open-angle glaucoma  
   
• More than 60 million people worldwide are affected by glaucoma which may lead to progressive vision loss[1],[2]

Basel, August 2, 2016 - Alcon, the global leader in eye care and a division of Novartis, announced today that it has achieved FDA approval for the CyPass^® Micro-Stent, a micro invasive glaucoma surgical (MIGS) device to treat patients with mild to moderate primary open-angle glaucoma in conjunction with cataract surgery. CyPass Micro-Stent is the latest addition to Alcon's surgical portfolio providing an additional option to meet the needs of millions of glaucoma patients.

The FDA approval is based on the landmark COMPASS Study, the largest MIGS study to date with a two-year follow-up for over 500 mild to moderate glaucoma patients undergoing cataract surgery. The primary effectiveness endpoint was met, with 73% in the CyPass Micro-Stent study group achieving a statistically significant decrease (>= 20%) in intraocular pressure (IOP). 

The secondary effectiveness endpoint was also met, with 61% of patients in the CyPass study group achieving a target IOP (between 6 and 18 mmHg) at the 24-month postoperative examination without medication, which is a statistically significant difference.   

"We are pleased by the FDA's decision to approve our CyPass Micro-Stent which establishes Alcon's presence in this emerging surgical category to treat mild to moderate glaucoma," said Mike Ball, CEO of Alcon. "It will provide a less invasive means of lowering IOP than traditional glaucoma surgery, with the goal of lowering the patient's dependence on topical glaucoma medication. We are excited to offer this new option to surgeons and the patients they serve."

Acquired in February 2016 by Alcon, Transcend Medical, Inc. developed the CyPass Micro-Stent to treat mild to moderate primary open-angle glaucoma. The MIGS device is implanted just below the surface of the eye in conjunction with cataract surgery. It is designed to treat less severe glaucoma by enhancing part of the natural drainage pathways of the eye with minimal tissue disruption. This allows the excess fluid in the eye to drain with the goal of reducing intraocular pressure levels.

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 methods.[1]-[3]

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 IOP in adult patients with mild to moderate primary open-angle glaucoma. The use of the CyPass Micro-Stent is contraindicated in eyes with angle closure glaucoma and eyes with traumatic, malignant, uveitic or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle. If IOP is not adequately maintained after implantation of a CyPass Micro-Stent, additional therapy may be needed for IOP control. 

In a randomized, multicenter clinical trial comparing cataract surgery with CyPass to cataract surgery alone, the most common post-operative adverse events included: Best Corrected Visual Acuity (BCVA) loss of 10 or more letters at 3 months after surgery (8.8% for CyPass vs. 15.3% for cataract surgery only); anterior chamber cell and flare requiring steroid treatment 30 or more days after surgery (8.6% vs. 3.8%); worsening of visual field mean deviation by 2.5 or more decibels (6.7% vs. 9.9%); IOP increase of 10 or more mmHg 30 or more days after surgery (4.3% vs. 2.3%); and corneal edema 30 or more days after surgery, or severe in nature (3.5% vs. 1.5%). Please refer to the Instructions for Use for the CyPass Micro-Stent for a complete list of contraindications, warnings, precautions and adverse events. 

Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as "may," "portfolio," "emerging," "will," "goal," "excited," "offer," 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 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, 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.

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 2015, the Group achieved net sales of USD 49.4 billion, while R&D throughout the Group amounted to approximately USD 8.9 billion (USD 8.7 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 119,000 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] Lighthouse International. Prevalence of Vision Impairment. http://www.lighthouse.org/research/statistics-on-vision-impairment/prevalence-of-vision-impairment/.
[2] Quigley and Broman. The Number of People with Glaucoma Worldwide in 2010 and 2020. Br J Ophthalmol 2006;90:262-7.
[3] http://myeyes.com/glaucoma.shtml

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