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Media Release

New data on the CyPass® Micro-Stent find fewer disease progression events, reduced dependence on traditional medications in glaucoma patients undergoing cataract surgery

  • New analyses from COMPASS, the first 500+ patient MIGS clinical trial, to be presented during the 2018 American Glaucoma Society annual meeting
  • Lower incidence of adverse events associated with glaucoma disease progression found in patients implanted with the CyPass® Micro-Stent
  • Analysis from a circadian model shows reductions in both mean intraocular pressure and the amplitude of fluctuations throughout the day in glaucoma patients

NEW YORK – March 1, 2018 – Alcon, the global leader in eye care and a division of Novartis, today presented new data from the COMPASS Randomized Controlled Trial that reinforce the clinical value of its CyPass® Micro-Stent, a microinvasive glaucoma surgery (MIGS) device implanted at the time of cataract surgery in patients with mild-to-moderate primary open-angle glaucoma. The data were presented today at the 2018 American Glaucoma Society (AGS) annual meeting, taking place March 1-4, 2018 in New York City.

“We are encouraged by this new data because it has potential real-world implications for patients and physicians struggling to manage glaucoma and who might be looking for better surgical options,” said Jaime Dickerson, Senior Global Brand Medical Affairs Lead, Alcon. “The CyPass® Micro-Stent is not only an important contribution to the MIGS space, but it may also help to slow the progression of glaucoma and stabilize intraocular pressure throughout the day, while helping to relieve patients of the burden of adhering to daily topical medications.”

The COMPASS clinical trial for the CyPass® Micro-Stent was the first MIGS study with a two-year follow-up for more than 500 patients with mild-to-moderate primary open-angle glaucoma (POAG) undergoing cataract surgery. In a post-hoc analysis, the incidence of markers associated with disease progression was compared between the CyPass® Micro-Stent group and the control group (cataract surgery only). There was a lower incidence in events associated with glaucoma disease progression, including adverse events for visual field deterioration, optic disc hemorrhage, intraocular pressure (IOP) spikes, and the need for additional glaucoma surgery, in patients implanted with the CyPass®Micro-Stent at the time of cataract surgery than in the control group. The difference in the occurrence of IOP spikes was statistically significant (P<0.001).

The analysis also shows that a lower proportion of patients in the COMPASS trial who were implanted with the CyPass® Micro-Stent at the time of cataract surgery required IOP-lowering medications at 24 months post-implantation (15.2 percent) than those who had cataract surgery alone (40.9 percent).

In a different study fitting the COMPASS data to a circadian IOP model, the results suggest that implantation of the CyPass® Micro-Stent resulted in lower mean daily IOP compared to the control group (16.6 mmHg vs. 17.7 mmHg) and a smaller amplitude of IOP fluctuations throughout the day (0.36 mmHg vs. 0.69 mmHg).

These findings will be presented during a scientific poster session at AGS on Thursday, March 1, 7 – 8 a.m. in the Astor Ballroom, New York Marriott Marquis:
 

  • Supraciliary Micro-Stent is Associated with Lack of Disease Progression and Minimum Usage of IOP Lowering Medications in Patients with POAG 2-Years Post-Implantation, Presented by Dr. Brian Flowers
  • Evaluation of IOP and a 24-Hour Circadian Rhythm Model after Implantation with a Supraciliary Micro-Stent, Presented by Dr. Brian A. Francis

The CyPass® Micro-Stent is implanted just below the surface of the eye, and is uniquely designed to reduce IOP in patients with mild-to-moderate primary open-angle glaucoma. It is the first FDA-approved 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.

About Glaucoma 

Glaucoma refers to a group of diseases in which there is progressive damage of the optic nerve. It is the leading cause of blindness worldwide, affecting more than 60 million people globally. Early diagnosis of glaucoma is critical to managing the disease, as glaucoma 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 irreversible loss of vision and blindness. Many glaucoma treatments address elevated pressure in the eye (intraocular pressure, or IOP), a major risk factor for optic nerve damage, and the only known modifiable risk factor for glaucoma1,2.

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 for a complete list of contraindications, warnings, precautions and adverse events.

References

  1. Tham, Yih-Chung et al. Global Prevalence of Glaucoma and Projections of Glaucoma Burden through 2040. Ophthalmology. 2014:121:2081-90. http://www.aaojournal.org/article/S0161-6420(14)00433-3/fulltext. Accessed October 3, 2017.
  2. National Eye Institute. Facts About Glaucoma. https://nei.nih.gov/health/glaucoma/glaucoma_facts. Accessed October 3, 2017.