A single event stood out in everyone’s mind when Ophthalmology Times asked experts to think back on the year in glaucoma surgery: the July 29 approval by the U.S. Food and Drug Administration (FDA) of the CyPass Micro-Stent.
The CyPass, developed by Transcend Medical of Menlo Park, provides an alternative to the only other minimally invasive glaucoma surgery (MIGS) device currently in the U.S. market, the iStent Trabecular Micro-Bypass Stent System sold by Glaukos.
“There has been really a revolutionary change in our field since the introduction of the iStent,” said Andrew Iwach, MD, executive director, Glaucoma Center of San Francisco, San Francisco.
Since winning approval June 25, 2012, the iStent has soared in popularity, with implantations overtaking trabeculectomy as the most commonly billed glaucoma procedure in Medicare, Dr. Iwach said.
CyPass and iStent both provide surgical relief of IOP without creating a filtering bleb and its attendant risks.
The CyPass acts as a conduit between the anterior chamber and the supraciliary space, while the iStent bypasses the inner wall of Schlemm’s canal and allows aqueous humor more direct access from the anterior chamber to the collector channels at the outer aspect of Schlemm’s canal.
Other MIGS devices achieved milestones on the route to the U.S. market in 2016.
- Allergan announced the FDA granted approval of its Xen Glaucoma Treatment System, a gelatin micro-stent that works by subconjunctival filtration. At the American Society of Retina Specialists (ASRS) annual meeting, the company presented data showing promise for the device both with cataract surgery and as a standalone procedure for mild to moderate primary open-angle glaucoma (POAG), and for use with mitomycin-C. The Xen also already has approval in Europe where it is indicated for the reduction of IOP in patients with primary open-angle glaucoma for whom previous medical treatments have failed.