Rhopressa (netarsudil ophthalmic solution) filed with FDA for patients with glaucoma or ocular hypertension- Aerie Pharmaceuticals
Aerie Pharmaceuticals announced the submission of its New Drug Application (NDA) to the FDA for Rhopressa (netarsudil ophthalmic solution) 0.02%. Rhopressa is a novel once-daily eye drop designed to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. The filing includes the results of the first two Phase III registration trials for Rhopressa, named Rocket 1 and Rocket 2.
Rocket 2 represents the pivotal trial and Rocket 1 is supportive. Rocket 3 is a 12-month safety-only study in Canada which is not needed for the NDA filing. Rocket 4 is designed to provide adequate six-month safety data for regulatory filing purposes in Europe, and is also not needed for the NDA filing.
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