The US Food and Drug Administration (FDA) has accepted Allergan’s 510(k) premarket notification application (PNA) for the XEN glaucoma treatment system.
XEN glaucoma treatment system is comprised of XEN45 gel stent and the XEN injector.
XEN45 is a minimally invasive implantable crosslinked gelatin shunt designed to reduce intraocular pressure (IOP) associated with refractory glaucoma.
Glaucoma is a group of diseases that impair the eye’s optic nerve, resulting in vision loss and blindness.
The company received CE mark approval for XEN45 system to reduce intraocular pressure in patients with primary open angle glaucoma, where previous medical treatments have failed.
It is also approved for use in Canada, Switzerland and Turkey.
Allergan chief R&D officer David Nicholson said: "We are pleased that the FDA has accepted the 510(k) filing for the XEN Glaucoma Treatment System, an excellent complement to Allergan’s ongoing portfolio and development programs in this critical treatment area.
"We look forward to working together with the FDA to bring this treatment to market and, in doing so, offer a potential new option to millions of Americans who suffer from glaucoma."