NDA Archives

A treatment for dry eye symptoms associated with Meibomian gland dysfunction (MGD) has been submitted under a New Drug Application (NDA) and will be considered by the US Food and Drug Administration. The application was submitted at the end of last month (June) by the Canada-based global eye health company, Bausch and Lomb Corporation, and German-based Novaliq – a biopharmaceutical company focusing on ocular therapeutics. The companies, both dedicated to helping people to see and live better are seeking approval for NOV03 (perfluorohexyloctane) – an investigational treatment associated with MGD. Dry eye disease Joseph C Papa, CEO and chairman at Bausch and Lomb said: “We are thrilled to have the potential to advance the care of people suffering from dry eye disease associated with Meibomian gland dysfunction. If approved by the FDA, NOV03 will be the first available therapy indicated to address the signs and symptoms for this patient population. The NOV03 filing is an example of the commitment of Bausch + Lomb toward bringing novel treatment options to the industry so that we can better serve patients.” Dry eye disease (DED) is one of the most common ocular surface disorders, with approximately 18 million Americans currently diagnosed with it. MGD is a major cause of the development and progression of evaporative DED, which is caused by a deficient tear film lipid layer that leads to increased tear evaporation. In one study, it was found that approximately 86% of patients with DED had MGD involvement. Christian Roesky, CEO of Novaliq said: “We are working hand-in-hand with Bausch + Lomb to bring this novel treatment option, if approved, to the optometric and ophthalmic community so they can help address the needs of patients with dry eye disease associated with Meibomian gland dysfunction. Water-free therapy “This New Drug Application submission is a critical milestone and the first drug submission of a water-free therapy. We are excited to unfold the full potential of NOV03 by bringing this novel drug option for this condition to the United States.” NOV03 is an investigational, proprietary, water-free, single-component preservative-free eye drop. In 2019, Bausch + Lomb acquired an exclusive license for the commercialization and development of NOV03 in the United States and Canada.

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