Allergan’s chronic eye disease treatment meets endpoints in pivotal trials
pharmafile | May 17, 2016 | News story | Manufacturing and Production, Sales and Marketing | Allergan, FDA, chronic eye disease
Allergan has announced positive top line results from two pivotal late-stage trials for the first and only neurostimulation device for increasing tear production in dry eye disease.
The Oculeve Intranasal Tear Neurostimulator was put the test in the OCUN-009 and OCUN-010 trials and met the primary and secondary endpoints in each. The handheld device with daily disposable tips increased tear production upon stimulation in patients with dry eye disease due to decreased tear production.
Chronic dry eye disease affects over 25 million people. It is usually caused by advanced age, contact lens wear, certain medications, eye diseases, other medical conditions or environmental factors. Without enough tears, the film protecting the eye can break down, creating dry spots on the cornea.
With the trials testing the device on over 200 adult patients, the positive safety and efficacy of the device is set to lead to a regulatory submission to the US Food and Drug Administration (FDA) by the end of the year.
David Nicholson, chief R&D officer at Allergan, comments: “We are excited with the outcome of these two sets of pivotal data. The Oculeve Intranasal Tear Neurostimulator is a novel approach and has the potential to help patients suffering from dry eye by increasing their natural tears. This device is part of Allergan’s strong eye care development pipeline and will complement our leading dry eye treatment Restasis. This is a major step forward in providing a promising new option for eye care professionals and their patients with dry eye disease.”
Sean Murray
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