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Rhopressa

Treatment for Glaucoma

Aerie Pharmaceuticals Submits NDA to U.S. FDA for Rhopressa (netarsudil ophthalmic solution) 0.02%

IRVINE, Calif.--(BUSINESS WIRE) September 6, 2016 -- Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of glaucoma and other diseases of the eye, today 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%. 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.

"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," 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 Roclatan (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 Rhopressa 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.

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 Rhopressa (netarsudil ophthalmic solution) 0.02% was filed in the third quarter of 2016. The second product candidate, Roclatan (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 Roclatan NDA filing is expected to take place in the second half of 2017.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "exploring," "pursuing" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the success, timing and cost of our ongoing and anticipated preclinical studies and clinical trials for our current product candidates, including statements regarding the timing of initiation and completion of the studies and trials; our expectations regarding the clinical effectiveness of our product candidates and results of our clinical trials; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, our product candidates; our expectations regarding the commercialization of our product candidates; our expectations related to the use of proceeds from our initial public offering and the issuance and sale of our senior secured convertible notes and the issuance and sale of shares of our common stock in connection with our "at the market" sales agreements; our estimates regarding anticipated capital requirements and our needs for additional financing; the potential advantages of our product candidates; our plans to pursue development of our product candidates for additional indications and other therapeutic opportunities; our plans to explore possible uses of our existing proprietary compounds beyond glaucoma; our ability to protect our proprietary technology and enforce our intellectual property rights; and our expectations regarding strategic operations, including our ability to in-license or acquire additional ophthalmic products or product candidates. By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics and industry change, and depend on regulatory approvals and economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. We discuss many of these risks in greater detail under the heading "Risk Factors" in the quarterly and annual reports that we file with the Securities and Exchange Commission (SEC). In particular, the preclinical research discussed in this press release is preliminary and the outcome of such preclinical studies may not be predictive of clinical outcomes. Forward-looking statements are not guarantees of future performance and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Source: Aerie Pharmaceuticals, Inc.

Posted: September 2016

Rhopressa (netarsudil) FDA Approval History

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