UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 25, 2014
Aerie Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
Delaware | 001-36152 | 20-3109565 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification Number) |
135 US Highway 206, Suite 15
Bedminster, New Jersey 07921
(Address of principal executive offices) (Zip code)
Registrants telephone number, including area code: (908) 470-4320
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 7.01. | Regulation FD Disclosure. |
On February 25, 2014, Aerie Pharmaceuticals, Inc. (the Company) issued a press release announcing the results from a recently completed preclinical in vivo study of AR-13324 and its effect on episcleral venous pressure. A copy of the 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. |
(d) | Exhibits. |
The following exhibit relating to Item 7.01 shall be deemed to be furnished, and not filed:
99.1 | Press Release dated February 25, 2014. |
SIGNATURES
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: February 25, 2014 | By: | /s/ Richard J. Rubino | ||||
Richard J. Rubino | ||||||
Chief Financial Officer |
EXHIBIT INDEX
Exhibit |
Description | |
99.1 | Press Release dated February 25, 2014. |
Exhibit 99.1
Aerie Pharmaceuticals Announces Study Results Supporting Additional Mechanism of Action for Lead Glaucoma Drug Candidate AR-13324
AR-13324 Found to Lower Episcleral Venous Pressure (EVP) in Preclinical In Vivo Model, Providing Further Insight into Differentiated Efficacy Profile
BEDMINSTER, N.J., RESEARCH TRIANGLE PARK, N.C. & NEWPORT BEACH, Calif February 25, 2014 Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class glaucoma therapies, today announced the results of preclinical in vivo research demonstrating the ability of AR-13324 to reduce episcleral venous pressure (EVP) in the eye. AR-13324 previously has been shown to lower intraocular pressure (IOP) by increasing fluid outflow through the trabecular pathway, the eyes primary drain, and by reducing the production of fluid in the eye. The present study, sponsored by the Company and conducted by Jeffrey Kiel, Ph.D., and his team at the University of Texas Health Science Center, San Antonio, affirmed the hypothesis that AR-13324 also can lower IOP through a third mechanism of action, the reduction of EVP. This may represent a breakthrough in the lowering of IOP in patients with glaucoma and ocular hypertension.
According to the study results, administration of AR-13324 eye drops once daily demonstrated statistically significant reductions in EVP and IOP in an in vivo model following the third daily dose. EVP decreased by 35% relative to baseline, and IOP was reduced by 39%. Based on these results, the researchers estimated that up to 42% of the reduction in IOP caused by AR-13324 was due to the reduction in EVP. The study results will be presented at the 2014 annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) in May.
Casey Kopczynski, Ph.D., Aeries Chief Scientific Officer, commented, These data support an additional mechanistic explanation for the activity and clinical efficacy profile of AR-13324, distinguishing this compound from currently available glaucoma drugs, which typically have been found to have no effect on EVP. As expected in a drug that lowers EVP, AR-13324 previously demonstrated consistent IOP lowering irrespective of baseline IOP in our Phase 2b
clinical study, whereas the comparator agent, latanoprost, demonstrated reduced efficacy at lower baseline IOPs. AR-13324 also achieved large IOP reductions in normotensive subjects in our previous Phase 1 pharmacokinetics study. The current preclinical research adds further evidence of the differentiated profile of AR-13324.
IOP is determined by the contributions of four distinct mechanisms of action within the eye: aqueous humor (eye fluid) production, resistance to aqueous outflow via the trabecular meshwork and uveoscleral pathways, and EVP. Historical studies have shown that EVP accounts for approximately half of IOP in normotensive subjects and approximately one-third of IOP in patients with elevated pressures of 24 30 mmHg. Drugs that lower IOP without lowering EVP are most effective at high IOPs, where EVP is believed to contribute less to IOP, and are less effective at lower IOPs, where EVP is seen to constitute a larger portion of IOP.
About Aerie Pharmaceuticals, Inc.
Aerie is a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class glaucoma therapies. The Company is preparing for two Phase 3 registration trials, where the primary efficacy endpoint will be to demonstrate non-inferiority of IOP lowering for AR-13324 (dosed once daily) compared to timolol (dosed twice daily). In addition, the Company is conducting a Phase 2b clinical trial of its fixed-dose combination product PG324, where the primary efficacy endpoint will be to demonstrate superiority of PG324 to each of its components.
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, continue, estimates, anticipates, expects, plans, intends, may, could, might, will, should 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 clinical trials and anticipated Phase 3 and Phase 2b clinical trials for our current product candidates, including statements regarding the timing of initiation and completion of the 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 estimates regarding anticipated capital requirements and our needs for additional financing; our expectations regarding the clinical effectiveness of our product candidates and results of our clinical trials; the potential advantages of our product candidates, including reduction of EVP as an additional mechanism of action as discussed in this press release; our ability to protect our proprietary technology and enforce our intellectual property rights; and our expectations related
to the use of proceeds from our initial public offering. 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 section contained in our final prospectus from our initial public offering which is on file with the Securities and Exchange Commission (SEC), and in the quarterly and annual reports that we file with the SEC. 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.
Contacts
Aerie Pharmaceuticals
Richard Rubino, 908-470-4320
rrubino@aeriepharma.com
or
Burns McClellan, Inc. on behalf of Aerie Pharmaceuticals
Angeli Kolhatkar - Investors
akolhatkar@burnsmc.com
or
Justin Jackson - Media
jjackson@burnsmc.com
Both: 212-213-0006
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