Editor’s note: Since the time of these presentations, Allergan submitted a de novo application for the Oculeve Intranasal Tear Neurostimulator device. According to the FDA, this process provides a pathway for medical devices for which general and/or special controls provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device.
Chronic dry eye disease (DED) affects more than 25 million people and to date the only pharmacologic therapies are topical or involve punctal plugs.
Results from two studies wth a neurostimulator indicate there may be a new pathway to upregulate the body’s tear system.
The device (Oculeve Intranasal Tear Neurostimulator, Allergan) comprises a disposable tip with hydrogel that tops a durable, rechargable stimulator unit, said John Berdahl, MD, Vance Thompson Vision, Sioux Falls, SD. Five levels of patient-adjusted stimulation are part of the device as well.
The device was developed at Stanford University by Michael Ackermann, PhD; James Loudin, PhD; and Daniel Palanker, PhD.
Stephen C. Pflugfelder, MD, chair and professor of ophthalmology, Baylor College of Medicine, Houston, said clinicians now know tear secretion is regulated by the lacrimal functional unit, and that the nasal cavities play a role.
“Schirmer with nasal stimulation with a cotton-tip applicator is recognized to induce reflex tearing,” Dr. Pflugfelder said, “Nasal anesthesia decreases tear production by 34% in normal subjects.”
Goblet cells secrete mucin in response to neural stimulation, he added.
Several publications confirm dry eye may disrupt neural signaling of tear secretion by decreased corneal sensitivity, anticholingergic medications, autoantibodies to acetylcholine receptors, or inflammatory cytokines, Dr. Pflugfelder said.