Alcon introduces pre-loaded delivery system for the CyPass® Micro-Stent to enhance surgical experience

WASHINGTON, April 13, 2018 /PRNewswire/ -- Alcon, the global leader in eye care and a division of Novartis, launches the CyPass Ultra System designed to streamline the process of loading the CyPass Micro-Stent, a microinvasive glaucoma surgery (MIGS) device indicated for use in adult patients with mild-to-moderate primary open-angle glaucoma undergoing cataract surgery. The new system reduces the number of steps required to implant the CyPass Micro-Stent, to help deliver safe, consistent, long-term intraocular pressure (IOP) control.

"The introduction of the new CyPass Ultra System shows our commitment to partner with surgeons and continuously innovate in the surgical glaucoma space to ensure our technology delivers the best surgical experience possible," said Sergio Duplan, Region President, North America, Alcon. "This new pre-loaded system makes it easier for surgeons to deliver optimal outcomes for their glaucoma patients undergoing cataract surgery."

The CyPass Ultra System includes a pre-loaded CyPass Micro-Stent, which is housed in a loader tip attached to a hand-held surgical instrument called the CyPass applier. The CyPass Ultra System, along with the following data that reinforces the clinical value of the CyPass Micro-Stent, will headline the company's clinical program at the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting this year.

• Retrospective Review of Phacoemulsification Combined with a Suprachoroidal Stent Versus Phacoemulsification Combined with a Trabecular Bypass Stent for the Treatment of POAG (Drs. Steven Vold and Mike McFarland)
• Key Findings: In a retrospective review comparing 100 eyes undergoing cataract surgery combined with the CyPass Micro-Stent to 100 eyes undergoing cataract surgery with the Glaukos^® iStent ^®*, a greater percentage of eyes in the CyPass Micro-Stent arm achieved IOP?18 mmHg at 12 months post-surgery (82% vs. 55%, p<0.001). In addition, the mean IOP at 12 months post-surgery was 2.11 mmHg lower in the CyPass Micro-Stent arm (p<0.001).
• Interim Report of Outcomes of a Supracilliary Micro-Stent in Primary Open-Angle Glaucoma Patients (Drs. William Clifford and Jaime Dickerson)
• Key Findings: Interim results from the COMPASS extension study showed similar safety outcomes for CyPass Micro-Stent with cataract surgery as compared to cataract surgery alone, as well as sustained IOP lowering efficacy through 48 months post-surgery. 
• Effect of Supracilliary Micro-Stent Implantation Concurrent with Cataract Surgery on the Accuracy of IOL Calculations in Patients with Open-Angle Glaucoma (Dr. Brian Flowers)
• Key Findings: The CyPass Micro-Stent had minimal effects on predicted refractive outcome, and no statistical differences were found in refractive outcomes of 43 eyes undergoing cataract surgery with the CyPass Micro-Stent and 43 eyes undergoing cataract surgery alone.  
• Noninterventional Study of Data Extracted from an EHR-Based Registry to Assess Long-Term Outcomes of a Supraciliary Micro-Stent (Drs. Stephen Lane, Flora Lum and Alvin Relucio)
• Key Takeaways: In collaboration with the American Academy of Ophthalmology, Alcon plans to enroll 4,000 patients implanted with the CyPass Micro-Stent from the IRIS database over a 5-year period to collect real-world data that will be relevant to clinical usage and practice.

"Traditional treatment options for glaucoma patients can prove challenging for a variety of reasons, many of which reduce adherence and can worsen outcomes," said Dr. William Clifford, Fry Eye Associates, Garden City, Kansas. "We are excited about the long-term data that show the CyPass Micro-Stent has real promise for safely filling an unmet need in this population and can help reduce the reliance on topical medications."

The CyPass Micro-Stent received Food and Drug Administration (FDA) approval in 2016. This new pre-loaded system is expected to be widely available to surgeons in May 2018.  

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 the CyPass Micro-Stent 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 the CyPass Micro-Stent 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 available at www.alcon.com for a complete list of contraindications, warnings, precautions and adverse events.

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 "potential," "can," "will," "plan," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. 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 that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be widely available and/or commercially successful in the future. In particular, our expectations regarding such products 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; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, 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.

*Glaukos^® and iStent^® are registered trademarks of Glaukos Corporation.

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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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 122,000 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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