Eyeworld

EW CORNEA 64 July 2016 by Liz Hillman EyeWorld Staff Writer Intranasal device stimulates a reflex pathway that produces natural tears for dry eye patients F rom warm compresses to drops to punctal plugs, there are a range of options to offer some relief to dry eye patients. Yet a 2008 survey of nearly 8,000 ophthalmol- ogists in the U.S. revealed that 94% felt more treatment options were needed for patients with a moderate to severe form of the disease. 1 Michael Ackermann, PhD, vice president of neurostimulation, Allergan, San Francisco, held a biodesign fellowship at Stanford University from 2010 to 2012. There he spent a month in the ophthalmology department, ob- serving clinical care and looking for opportunities where it could be improved. Dry eye quickly presented itself as an obvious problem. "It seemed like every third patient was coming in the door with dry eye," he said. Doing a deep dive into the pathophysiology of this disease, Dr. Ackermann and his colleagues gained an understanding of the neural pathways involved in tear production. This led them to create a device that could stimulate natural tear production using electrical stimulation, a technique common in other areas of medicine such as pain control and movement disorder treatment. "Neurostimulation in general is a very widely used type of tech- nology. What's so neat about it is it offers clinicians the opportunity to allow patients to treat themselves by activating their own tear production system," Dr. Ackermann said. "It turns out that the tear film is made of up 3 components, all of which are neurally innervated." Dr. Ackermann started the com- pany Oculeve, which was acquired by Allergan (Dublin) in July 2015, to further develop the device, which began as a surgical implant less than the size of a fingertip. In its current design iteration though, the Oculeve Intranasal Tear Neurostimulator is a nonsurgical, externally applied device. It consists of a rechargeable handheld unit and a disposable hy- drogel tip, which is inserted into the nasal passage and used to stimulate the trigeminal nerve. Three studies using the neurostimulator were presented at the 2016 ASCRS•ASOA Sympo- sium & Congress in New Orleans: 1 randomized and controlled trial showing increased tear production over 2 controls (Richard Lewis, MD); 1 study showing safety and effectiveness over 180 days of use (Arturo Chayet, MD); and 1 randomized and controlled study showing that the device increases the mucin layer and the aqueous layer of the tear film with stimula- tion (Stephen Pflugfelder, MD). Oculeve was not originally destined to be an externally applied device, but a chance observation in some patients with the implant led to this discovery. Neurostimulation offers a new frontier in dry eye treatment D ry eye has certainly become a hot topic in the world of cornea and anterior segment with increasing focus on the importance of the tear film in refractive outcomes. While there are increasing treatment options for our dry eye patients, lubrication drops in many forms— preserved, non-preserved, lipid-containing, hyaluronate-containing, gels, ointments, etc.—have been the mainstay of treatment for patient symptoms. However, these can be messy, over time quite expensive, and some elderly patients or those with arthritis may have difficulty with using the dispens- ing bottles and minims. What if an alternate option existed? This month's "Cornea editor's corner of the world" focuses on a novel device that utilizes neurostimulation to engage our body's reflex pathway leading to tear production. Michael Ackermann, PhD, and Daniel Palanker, PhD, discuss the back- ground of how this device was developed, how it can effectively stimulate production of all 3 layers of the tear film (lipid, aque- ous, and mucin), and some of the results from early clinical studies. Clara Chan, MD, FRCSC, FACS, cornea editor The Oculeve Intranasal Tear Neurostimulator is a nonsurgical device administered in a patient's nose, stimulating the trigeminal nerve with electrical impulses to produce natural tears. Cornea editor's corner of the world The device consists of a rechargeable handheld unit and a disposable hydrogel tip. Source: Allergan

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