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.--(BUSINESS WIRE)--
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
eye's 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., Aerie's 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.
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.
Richard Rubino, 908-470-4320
McClellan, Inc. on behalf of Aerie Pharmaceuticals
Jackson - Media
Source: Aerie Pharmaceuticals, Inc.
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