The company has submitted de novo application to the FDA for the handheld stimulator, which was investigated to temporarily increase tear production upon activation in patients with dry eye disease due to decreased tear production.
According to the FDA, this process offers a pathway for medical devices for which general or special controls provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device.
The two pivotal trials of the Oculeve device met their effectiveness endpoints, said the company.
Dry eye disease, which affects around 31 million people, occurs due to an advanced age, contact lens wear, certain medications and other medical conditions or environmental factors.
Without adequate tears, the film protecting the eye can break down, creating dry spots on the cornea.
Allergan chief R&D officer David Nicholson said: "The Oculeve intranasal tear neurostimulator is an exciting potential option for patients suffering from dry eye disease, and we are pleased to have filed the de novo application with FDA that will allow patients to gain access to this novel medical device.”
In June, the FDA accepted Allergan’s 510(k) premarket notification application (PNA) for the XEN glaucoma treatment system, which includes XEN45 gel stent and XEN injector.
XEN45 is a minimally invasive implantable crosslinked gelatin shunt designed to reduce intraocular pressure (IOP) associated with refractory glaucoma.
