Allergan plc announced that it has filed with the U.S. FDA the 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.
This handheld stimulator was investigated for temporarily increasing tear production upon activation in patients with dry eye disease due to decreased tear production. Recently Allergan announced that two pivotal trials of the Oculeve Intranasal Tear Neurostimulator each met their effectiveness endpoints.
“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,” said David Nicholson, Chief R&D Officer, at Allergan.
The Oculeve Intranasal Tear Neurostimulator will complement Allergan’s robust existing dry eye portfolio and provide physicians with a significant opportunity to treat more patients through this novel, device-based approach.
About Dry Eye Disease
Dry eye disease affects over 31 million people. It can be 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.
Allergan plc headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women’s health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world’s third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.For more information, visit Allergan’s website at www.allergan.com