Nicox PursuesTransformation Into Ophthalmic Specialty Company – And Partner
Nicox of France pins hopes on glaucoma drug Vesneo – targeted for FDA submission in second quarter 2015 – and recent purchase of Aciex Therapeutics to build itself into an international ophthalmic player and ‘partner of choice’ in Europe.
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The latest drug development news and highlights from our FDA Performance Tracker.
Recent progress on the US regulatory front is generating renewed interest in device-based glaucoma therapies, which potentially could grow to a multibillion-dollar industry. The list of companies targeting this space continues to expand, as does the variety of potential device-based solutions: the current pipeline includes several innovative and less invasive products and technologies designed to improve surgical outcomes, a growing number of advanced drug-delivery inserts to address the patient noncompliance issue that is so common in this arena, and some unique patient monitoring devices.
Naproxcinod Must Show More Data On Both Safety And Therapeutic Benefit After "Complete Response" Letter
FDA tells NicOx it wants long-term studies on drug's cardiovascular and gastrointestinal safety, but no additional efficacy trials.