Alcon presents new data on the CyPass® Micro-Stent in patients with mild-to-moderate primary open-angle glaucoma
Oct 07, 2017
Two studies involving nearly 1,000 patients demonstrated the safety and efficacy of the CyPass® Micro-Stent in patients suffering from glaucoma
The CyPass® Micro-Stent is designed to reduce intraocular pressure (IOP) in patients with mild-to-moderate primary open-angle glaucoma undergoing cataract surgery
More than 60 million people are affected by glaucoma, the leading cause of irreversible blindness worldwide
LISBON, Portugal – October 7, 2017 - Alcon, the global leader in eye care and a division of Novartis, announced today that additional data from the COMPASS and CyCLE clinical studies reinforce the efficacy and safety profile of its CyPass® Micro-Stent, a micro-invasive glaucoma surgical (MIGS) device to treat cataract patients with mild-to-moderate primary open-angle glaucoma. The additional data will be presented during the XXXV congress of the European Society of Cataract & Refractive Surgeons (ESCRS) taking place October 7 – 11 in Lisbon, Portugal.
“The new findings from COMPASS and CyCLE confirm the CyPass® Micro-Stent as a key option for managing glaucoma,” said Stephan Eigenmann, Surgical Franchise Head, Europe, Middle East and Africa (EMEA), Alcon. “With innovations like the CyPass® Micro-Stent, we are demonstrating Alcon’s commitment to developing technologies that improve people’s lives.”
The CyPass® Micro-Stent, implanted just below the surface of the eye, is uniquely designed to reduce IOP in patients with mild-to-moderate primary open-angle glaucoma. This is the first marketed 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 represents a new option that is less invasive than traditional glaucoma surgery,” explained Keith Barton, M.D., a glaucoma specialist at Moorfields Eye Hospital in London. “It is also important to emphasize that it helps reduce the patient treatment burden by lowering dependence on topical glaucoma medications.”
The COMPASS clinical trial is the largest MIGS study to date with a two-year follow-up for more than 500 mild-to-moderate glaucoma patients undergoing cataract surgery. One new analysis shows that best-corrected visual acuity (BCVA) outcomes were similar between the control group and CyPass® group at all time points through 24 months. In addition, Alcon will highlight data from COMPASS that reveals that of those patients who achieved the primary endpoint (unmedicated mean diurnal IOP reductions ≥ 20%), 93 percent were not using ocular hypotensive medication at 24 months, as compared to 72.4 percent of patients in the control group.
Alcon will also present the three-year results from the CyCLE Study for Supraciliary Micro-Stent Implantation Combined with Cataract. The main conclusions of the study reveal that at three years postoperative, subgroups with controlled and uncontrolled IOP at baseline (<21 mmHg and ≥21 mmHg, respectively) had a higher proportion of subjects using no medications and a lower proportion of subjects using three or more medications compared to baseline. In addition, at the 36-month postoperative examination, mean medicated IOP decreased by 8.1 mmHg in subjects with uncontrolled IOP at BL.
Data from the COMPASS and CyCLE studies will be presented on Monday, October 9 during the following times at the Feira Internacional de Lisboa (FIL) congress center:
Scientific Paper Presentation: Ocular Hypotensive Medication Use in Patients Undergoing Combined Cataract Surgery and Supraciliary Micro-Stent Implantation for Open-Angle Glaucoma in the COMPASS Trial, Dr. S. Sarkisian, Jr. (9:12 – 9:18 a.m., Room 4.1, FIL congress center)
Scientific Paper Presentation: Three-year Results from the CyCLE Study for Supraciliary Micro-Stent Implantation Combined with Cataract Surgery for Open-Angle Glaucoma, Dr. H. Hoh (9:30 – 9:36 a.m., Room 4.1, FIL congress center)
Scientific Paper Presentation: Combined Cataract Surgery and Supraciliary Micro-Stent Implantation for Open-Angle Glaucoma: BCVA Outcomes from the COMPASS Trial, Dr. T. Ianchulev (9:36 – 9:42 a.m., Room 4.1, FIL congress center)
The CyPass® Micro-Stent has now launched in Spain, Germany and UK.
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 with a CE mark indication for use (a) in conjunction with cataract surgery for the reduction of IOP in adult patients with mild to moderate primary open-angle glaucoma, and (b) for use in conjunction with cataract surgery or as a standalone procedure for the reduction of IOP in adult patients with primary open-angle glaucoma in cases 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.
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 (last visited October 3, 2017).