FDA clears Allergan's $300M glaucoma gel stent

Allergan HQ
Allergan headquarters

Allergan has been aggressively pursuing treatments for “underserved” eye diseases, shelling out hundreds of millions on a pair of glaucoma device makers in the past 18 months. Now, its bet on a gel stent and injector combo is paying off: It bagged an FDA nod Tuesday for the treatment of refractory glaucoma.

Picked up in Allergan’s $300 million acquisition of AqueSys in September 2015, the Xen Glaucoma Treatment System is a new surgical option for patients in whom previous surgery and medicines have failed. The Xen45 gel stent is a soft shunt made of collagen-derived gelatin about the width of a human hair. It is implanted using a preloaded injector through an incision in the cornea.

Glaucoma refers to a group of diseases that affect the optic nerve and can cause vision loss or blindness. It is often caused by abnormally high pressure in the eye. The Xen45 implant relieves this pressure by creating a channel through which aqueous humor can drain from the anterior chamber—which is between the cornea and iris—into the area beneath the conjunctiva. Intraocular pressure (IOP) in glaucoma patients is currently treated with eye drop therapies, but these are fiddly to use and can have low patient adherence.

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"XEN is a new option that provides an opportunity for surgical intervention in refractory glaucoma patients,” said Dr. Robert Weinreb, chairman and distinguished professor of Ophthalmology at the University of California, San Diego, in a statement. Studies have shown that after using the Xen implant for 12 months, patients used less eye drop medication than they did before implantation, he said.

The U.S. pivotal trial involved 52 patients and showed that the average use of IOP-lowering drugs at 12 months was 1.7, about half of the average 3.5 the patients used before treatment, according to the statement.

Allergan plans to launch the Xen system in the U.S. early next year. Meanwhile, the pharma continues to forge ahead in the “underserved” eye disease arena—in September, it acquired ForSight Vision and its in-development periocular ring for glaucoma in a $95 million deal. And in July, Allergan filed a de novo application with the FDA for the dry eye neurostimulator it snagged in its $125 million acquisition of Oculeve.

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