IRVINE, Calif.--(BUSINESS WIRE)--Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of first-in-class therapies for glaucoma and other diseases of the eye, today announced that two paper abstracts and two poster abstracts are scheduled to be presented at the American Glaucoma Society (AGS) 26th Annual Meeting, taking place March 3-6, 2016, in Fort Lauderdale, Florida. These presentations provide additional insights into AR-13324, an active ingredient in both of Aerie’s advanced clinical-stage products, RhopressaTM (netarsudil ophthalmic solution) 0.02% and RoclatanTM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%. AR-13324 has recently been granted the USAN name “netarsudil.” The abstracts will be posted on Aerie’s website on March 3, 2016, including all investigator credits.
“Anti-fibrotic Effects of AR-13324 in a 3D Bioengineered Human Trabecular Meshwork Model”
Paper Abstracts:
- “Topical Administration of a ROCK/NET Inhibitor Promotes Retinal Ganglion Cell Survival and Axon Regeneration,” to be presented by Jeffrey Goldberg, M.D., Professor and Chair of Ophthalmology at the Byers Eye Institute at Stanford University
- “Anti-fibrotic Effects of AR-13324 in a 3D Bioengineered Human Trabecular Meshwork Model,” to be presented by Cheng-Wen Lin, Ph.D., Aerie Pharmaceuticals
Poster Abstracts:
- “The Mechanisms of Increasing Outflow Facility by AR-13324M in Human Eyes,” to be presented by Haiyan Gong, M.D., Ph.D., Professor of Ophthalmology and Anatomy and Neurobiology at Boston University
- “AR-13324 Ophthalmic Solution 0.02%: Topline Results of Two Phase 3 Clinical Studies in Patients with Open-Angle Glaucoma and Ocular Hypertension,” to be presented by Jason Bacharach, M.D., North Bay Eye Associates, Petaluma, CA
“These four abstracts provide meaningful insights into the differentiating characteristics of RhopressaTM. The abstracts include details associated with product attributes we have discussed in the past, including the potential effects of RhopressaTM on outflow mechanisms. In addition, for the first time promising new preclinical data supporting the neuroprotection potential of RhopressaTM will be presented,” said Vicente Anido, Jr., Ph.D., Chief Executive Officer and Chairman at Aerie.
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-daiIy IOP-lowering therapies with novel mechanisms of action to treat patients with glaucoma and ocular hypertension. It is expected that the NDA filing for RhopressaTM (netarsudil ophthalmic solution) 0.02% will take place 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 one Phase 3 registration trial underway, named Mercury 1, with a second trial expected to commence in March 2016. If these trials are successful, a RoclatanTM NDA filing is expected to take place in the second half of 2017. Aerie also announced in 2015 its research collaborations with GrayBug, Inc. and Ramot at Tel Aviv University as it further builds its pipeline for future growth.
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; and 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 the outcome of later clinical trials. Any future clinical trial results may not demonstrate safety and efficacy sufficient to obtain regulatory approval related to the preclinical research findings discussed in this press release. 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.
Aerie Pharmaceuticals
Richard Rubino, 908-947-3540
rrubino@aeriepharma.com
or
Burns McClellan, Inc., on behalf of Aerie Pharmaceuticals
Investors
Ami Bavishi, 212-213-0006
abavishi@burnsmc.com
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Media
Justin Jackson, 212-213-0006
jjackson@burnsmc.com