Allergan’s Oculeve on track for FDA submission this year

Allergan (NYSE:AGN) said today that it’s on track for an FDA submission this year for the 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. Today the company said a pair of pivotal trials passed their safety and efficacy endpoints, clearing the way for a pre-market approval submission in the 2nd half of the year. 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 Oculeve device for 6 months, with a safety endpoint of device-related adverse events and the same efficacy endpoint as OCUN-009. Allergan said all device-related adverse events were mild and no patients stopped treatment due to an adverse event, and that the efficacy endpoint was also met. “We are excited with the outcome of these 2 sets of pivotal data,” chief R&D officer David Nicholson said in prepared remarks. “The Oculeve intra...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Food & Drug Administration (FDA) Optical/Ophthalmic Regulatory/Compliance Allergan Inc. Oculeve Source Type: news

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