Allergan asks FDA to approve Oculeve neurostim device

Allergan (NYSE:AGN) said today that it filed a de novo approval application with the FDA for its Oculeve nasal neurostimulation device for dry eye it bought last year. Oculeve is a hand-held device designed to be inserted into the nostril to stimulate the nerves serving the lacrimal gland. Allergan paid $125 million plus unspecified milestones for Oculeve last year. The de novo protocol is for low- to moderate-risk devices that don’t have a “substantially equivalent predecessor” device already on the market. “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,” chief R&D officer David Nicholson said in prepared remarks. In May the company said a pair of pivotal trials passed their safety and efficacy endpoints, clearing the way for a pre-market approval submission. The 48-patient OCUN-009 trial evaluated intra- and extra-nasal use of the Oculeve device compared with sham intra- and extra-nasal treatments at 6 months, using a safety endpoint of device-related adverse events and an efficacy endpoint of tear production during treatment with tear production during the sham applications. Allergan said the study met the efficacy endpoint. The 2nd study, OCUN-010, tracked 97 subjects who used the Oculev...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Neuromodulation/Neurostimulation Optical/Ophthalmic Regulatory/Compliance Allergan Inc. Oculeve Source Type: news

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