Aerie Pharma (AERI) Announces Submission of Rhopressa NDA to FDA for IOP

September 6, 2016 4:02 PM EDT

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Aerie Pharmaceuticals, Inc. (Nasdaq: AERI) announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Rhopressa (netarsudil ophthalmic solution) 0.02%. RhopressaTM 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 RhopressaTM, named Rocket 1 and Rocket 2.

“The RhopressaTM 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,” said Vicente Anido, Jr., Ph.D., Chief Executive Officer and Chairman at Aerie.

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™

RhopressaTM (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, RhopressaTM provides an additional mechanism that reduces fluid production in the eye and therefore lowers IOP. Biochemically, RhopressaTM has been shown in Aerie studies to inhibit both Rho Kinase (ROCK) and norepinephrine transporter (NET). Recent preclinical studies have also shown that RhopressaTM 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 RhopressaTM.

The results of two Phase 3 registration trials (Rocket 2 and Rocket 1) for RhopressaTM 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.

About Aerie Pharmaceuticals, Inc.

Aerie is a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye. Aerie's two lead product candidates are once-daily IOP-lowering therapies with novel mechanisms of action to treat patients with glaucoma or ocular hypertension. The NDA for RhopressaTM (netarsudil ophthalmic solution) 0.02% was filed in the third quarter of 2016. The second product candidate, RoclatanTM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, which is a fixed dose combination of RhopressaTM and widely prescribed PGA latanoprost, currently has two Phase 3 registration trials underway, named Mercury 1 and Mercury 2. If these trials are successful, a RoclatanTM NDA filing is expected to take place in the second half of 2017.

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