LOS ANGELES, Nov. 22, 2016 /PRNewswire-USNewswire/ -- Millions of glaucoma patients whose previous surgical treatment failed to reduce their eye pressure have new hope following several years of pivotal clinical trials conducted in refractory glaucoma patients, including work done at the University of Southern California (USC) Roski Eye Institute, as Allergan announces the Xen® Glaucoma Treatment System has been approved by the U.S. Food and Drug Administration (FDA).
Rohit Varma, MD, MPH, director of the USC Roski Eye Institute and dean of the Keck School of Medicine of USC, who led the work at USC, has called the Xen implantable device "a game changer" especially for those patients where refractory surgery treatments have failed to reduce intraocular pressure (IOP). It also is a breakthrough for patients with primary open angle glaucoma, pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy.
In 2015, Varma reported the results of his study participants. One year after the implant, Varma found eye pressure was reduced 44 percent and IOP medications were reduced 65 percent. Allergan has said the Xen stent will be available in the U.S. in early 2017.
"In our quest to prevent blindness and provide treatments that are less invasive and more effective, the Xen implantable device creates a new horizon for glaucoma patients," says Varma. "We were excited to be part of the team where we created a drainage channel with the permanent yet flexible Xen implant and effectively lowered IOP and also reduced the drops needed for many patients."
According to the World Health Organization, glaucoma is the second leading cause of blindness worldwide and the American Academy of Ophthalmology reports that more than 3 million Americans have glaucoma but only half of those are diagnosed. Glaucoma can cause blindness when fluid builds up in the front part of the eye putting pressure on the optic nerve. Without releasing that pressure, damage to the optic nerve and potential blindness can occur.
"Glaucoma does not have to lead to blindness," added Varma. "Because there may be no symptoms and the disease progresses slowly, an annual eye exam, especially after the age of 50 that includes a dilated eye exam, will help prevent blindness with early detection and treatment."