This article is more than 5 years old. Information may no longer be current.
Aerie Pharmaceuticals submits NDA for Rhopressa
Click Here to Manage Email Alerts
Aerie Pharmaceuticals submitted a new drug application to the FDA for Rhopressa, a once-daily eye drop designed to lower IOP in patients with glaucoma or ocular hypertension.
The application includes results of the Rocket 1 and Rocket 2 studies, the first two phase 3 registration trials for Rhopressa (netarsudil ophthalmic solution 0.02%), according to a press release from Aerie.
The Rocket 2 study was a pivotal trial, and Rocket 1 was supportive. Rocket 3, a 12-month safety study being conducted in Canada, and Rocket 4, designed to provide 6-month safety data for regulatory filing in Europe, are not needed for the NDA filing, the release said.
The company expects the FDA review process to take the standard 12 months.
Rhopressa targets the trabecular meshwork, reduces episcleral venous pressure and fluid production in the eye, and has been shown to inhibit Rho kinase and the norepinephrine transporter.