Electronic Stimulator of Lacrimal Gland

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DESCRIPTION (provided by applicant): More than 25 million Americans have Dry Eye Disease (DED) with 3 million suffering from the most severe form - a debilitating condition with no effective treatments. Patients and physicians are desperate for a cure. Symptoms of DED include intense pain, light sensitivity, blurriness, increased risk of infection, and possible visin loss. Insufficient tear volume on the ocular surface in DED is initially caused by insufficient ter production or excessive tear evaporation. Insufficient tear volume results in tear hyperosmolarity, causing inflammation and nerve damage, leading to progressive loss of tear production and quality. RestasisTM - the only FDA approved medication for the treatment of DED, increases tear production by only 23%, and therefore does not significantly slow or reverse progression of the disease. We have demonstrated in both humans and in animal model that tear production can be dramatically increased by electrical stimulation of the lacrimal gland. We hypothesize that increase in tear volume should improve tear film osmolarity, ocular surface health, symptoms and therefore quality of life. It may also reverse the progression of disease. Electric current will be delivered to lacrimal gland via a RF- powered micro-stimulator inserted into the eye orbit next to the lacrimal gland. The stimulator safely and painlessly delivers electrical current to the lacrimal gland, restoring tear production. Power is wirelessly transmitted to the stimulator from a small RF transmitter placed on the temple of glasses, or as an adhesive patch on the patient's temple. Stimulation of lacrimal gland in rabbits demonstrated a dramatic increase in tear production over baseline: up to 7-fold (+600%). Acute clinical study with a commercially available external stimulator resulted in 3-fold (+195%) increase in tear production in patients with severe DED, compared to baseline. This is more than 8-fold improvement compared to RestasisTM. This project brings together a unique combination of engineers and ophthalmologists to complete the development and evaluate the efficacy and safety of the lacrimal gland stimulator. We will study the mechanisms of stimulation, optimize the electrode geometry and waveforms, and assess biocompatibility, safety and efficacy of chronic stimulation in animal model in preparation for translating this technology to clinical studies.