Aerie submits NDA to 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 3 registration trials for Rhopressa, named Rocket 1 and Rocket 2.

Aerie CEO and chairman Vicente Anido said: "The Rhopressa NDA filing represents a significant achievement for Aerie. We are very proud of our many dedicated employees who worked tirelessly to have this filing submitted on schedule. We expect a standard twelve-month FDA review process.

Dr. Anido continued, "In the meantime, we look forward to our Mercury 1 interim efficacy readout for RoclatanTM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, expected this month."

About Rhopressa

Rhopressa (netarsudil ophthalmic solution) 0.02%, is a novel eye drop that we believe, if approved, would become the only once-daily product available that, based on Aerie's preclinical studies, specifically targets the trabecular meshwork, the eye's primary fluid drain and the diseased tissue responsible for elevated IOP in glaucoma.

Preclinical studies have also demonstrated that RhopressaTM lowers episcleral venous pressure, which contributes approximately half of IOP in healthy subjects. Further, based on Aerie's preclinical studies, Rhopressa provides an additional mechanism that reduces fluid production in the eye and therefore lowers IOP.

Biochemically, Rhopressa has been shown in Aerie studies to inhibit both Rho Kinase (ROCK) and norepinephrine transporter (NET). Recent preclinical studies have also shown that Rhopressa may have disease-modifying properties, including an anti-fibrotic effect on the trabecular meshwork and the potential to increase perfusion of the trabecular meshwork.

Preclinical research is also currently underway to evaluate the potential neuroprotective benefits of Rhopressa.

The results of two Phase 3 registration trials (Rocket 2 and Rocket 1) for Rhopressa were submitted in the NDA filing. 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.