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|Item 7.01.||Regulation FD Disclosure.|
On October 24, 2019, Aerie Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that patient enrollment in its Phase 2 clinical trial of AR-1105 in patients with macular edema due to retinal vein occlusion is complete several weeks ahead of schedule. AR-1105 is an investigational sustained-release, bio-erodible intravitreal implant containing dexamethasone. A copy of this press release is furnished as Exhibit 99.1 hereto and is hereby incorporated by reference into this Item 7.01.
The information in this Item 7.01 (including Exhibit 99.1) is being furnished, not filed, pursuant to Regulation FD. Accordingly, the information in this Item 7.01 will not be incorporated by reference into any registration statement filed by the Company under the Securities Act of 1933, as amended, unless specifically identified therein as being incorporated therein by reference. The furnishing of the information in this Item 7.01 is not intended to, and does not, constitute a determination or admission by the Company that this information is material or complete, or that investors should consider this information before making an investment decision with respect to any security of the Company.
|Item 9.01.||Financial Statements and Exhibits.|
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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
AERIE PHARMACEUTICALS, INC.
Date: October 24, 2019
Richard J. Rubino
Chief Financial Officer
Aerie Pharmaceuticals Completes Enrollment in the Phase 2 Trial of AR-1105 (Dexamethasone Intravitreal Implant) in Patients with Macular Edema Associated with Retinal Vein Occlusion Ahead of Schedule
DURHAM, N.C. October 24, 2019 Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) (Aerie), an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, retinal diseases and other diseases of the eye, today announced that patient enrollment in its Phase 2 clinical trial of AR-1105 in patients with macular edema due to retinal vein occlusion (RVO) is complete several weeks ahead of schedule. AR-1105 is an investigational sustained-release, bio-erodible intravitreal implant containing dexamethasone.
The Phase 2 study (AR-1105-CS201), conducted at 19 centers in the United States, had an enrollment target of 45 patients. The trial is evaluating two formulations of AR-1105 (CF-1 and CF-2) that differ in the duration of dexamethasone release. A few additional patients are currently being screened and, if they are randomized, could bring the total number of patients in the final evaluation to a maximum of 49.
The primary objectives of the trial are to evaluate the safety, tolerability and efficacy of the AR-1105 dexamethasone intravitreal implant. Safety and efficacy will be evaluated at six months. More information about the study is available at www.clinicaltrials.gov under the study designation NCT 03739593.
We are grateful to our investigators and the patients who have enrolled in this proof-of-concept study for our proprietary sustained-release technology, said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer. We plan to conduct an interim analysis when the first 20 patients have reached the six month timepoint, which should be before the end of this year, making preliminary data available in 2020. The final patient visit should take place in Q2 2020. Meanwhile, our study team will be consulting with regulatory agencies in both the United States and the European Union as they move toward the design of our next trial of AR-1105 in DME.
AR-1105 is a bio-erodible implant that is designed to steadily release the steroid dexamethasone over a six-month period. It is administered by intravitreal injection, a commonly-used, in-office treatment method. In addition to its six-month duration of effect, the potential benefits of AR-1105 compared to other intravitreal steroid products include improved administration with a smaller 25G needle and the potential for fewer adverse events due to lower peak drug levels. The market for retinal disease therapeutics in the United States, which is dominated by anti-vascular endothelial growth factor agents, was approximately $6 billion in 2018. The intravitreal steroid segment represented approximately $200 million of that total.
About Aerie Pharmaceuticals, Inc.
Aerie is an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, retinal diseases and other diseases of the eye. Aeries first product, Rhopressa® (netarsudil ophthalmic solution) 0.02%, a once-daily eye drop approved by the U.S. Food and Drug Administration (FDA) for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, was launched in the United States in April 2018. In clinical trials of Rhopressa®, the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage. More information about Rhopressa®, including the product label, is available at www.rhopressa.com. Aeries second product for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, Rocklatan® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%, the first and only fixed-dose combination of Rhopressa® and the widely-prescribed PGA (prostaglandin analog) latanoprost, has been approved by the FDA and is now available in the United States. In clinical trials of Rocklatan®, the most common adverse reactions were conjunctival hyperemia, corneal verticillata, instillation site pain, and conjunctival hemorrhage. More information about Rocklatan®, including the product label, is available at www.rocklatan.com. Aerie continues to focus on global expansion and the development of additional product candidates and technologies in ophthalmology, including for wet age-related macular degeneration and diabetic macular edema. More information is available at www.aeriepharma.com.
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 Rhopressa® and Rocklatan®, with respect to regulatory approval outside of the United States or additional indications, and any current or future product candidates, including statements regarding the timing of initiation and completion of the studies and trials, such as statements in this press release regarding the clinical trials for AR-1105 and results of such clinical trials; our expectations regarding the commercialization and manufacturing of Rhopressa® and Rocklatan® or any future product candidates, including the timing, cost or other aspects of the commercial launch of Rhopressa® and Rocklatan® or any future product candidates; our commercialization, marketing, manufacturing and supply management capabilities and strategies; the timing of and our ability to request, obtain and maintain FDA or other regulatory authority approval of, or other action with respect to, as applicable, Rhopressa®, Rocklatan® or any future product candidates, including the expected timing of, and timing of regulatory and/or other review of, filings for, as applicable, Rhopressa®, Rocklatan® or any future product candidates; the potential advantages of Rhopressa® and Rocklatan® or any future product candidates; our plans to pursue development of additional product candidates and technologies within and beyond ophthalmology; our plans to explore possible uses of our existing proprietary compounds beyond glaucoma, including development of our retina program; 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, product candidates or technologies. By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics, industry change and other factors beyond our control, and depend on regulatory approvals and economic and other environmental 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, FDA approval of Rhopressa® and Rocklatan® do not constitute FDA approval of AR-1105, or any future product candidates, and there can be no assurance that we will receive FDA approval for AR-1105, or any future product candidates. FDA approval of Rhopressa® and Rocklatan® also do not constitute regulatory approval of Rhopressa® and Rocklatan® in jurisdictions outside the United States and there can be no assurance that we will receive regulatory approval for Rhopressa® and Rocklatan® in jurisdictions outside the United States. 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.
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