Alcon achieves US approval for CyPass® Micro-Stent, a micro invasive surgical device to treat glaucoma - Seite 2

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.