FDA Advisory Committee to Review New Drug
Application for Rhopressa™ (netarsudil ophthalmic solution)
0.02%
Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) (Aerie or the
Company), 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, today announced that NASDAQ has halted trading
of the Company’s common stock. A meeting of the Dermatologic and
Ophthalmic Drugs Advisory Committee of the U.S. Food and Drug
Administration (FDA) has been scheduled for today to review the
Company’s New Drug Application (NDA) for Rhopressa™ (netarsudil
ophthalmic solution) 0.02% for the treatment of patients with
open-angle glaucoma or ocular hypertension. Aerie submitted the NDA
for Rhopressa™ to the FDA in February 2017, following which the FDA
set a PDUFA (Prescription Drug User Fee Act) goal date of February
28, 2018 for the completion of its review of the Rhopressa™
NDA.
The Advisory Committee meeting is scheduled to begin at 8:30
a.m. ET today. Additional information can be found on the FDA
website, www.fda.gov.
About Rhopressa™
Rhopressa™ (netarsudil ophthalmic solution) 0.02%, is a novel
eye drop that the Company believes, if approved, would become the
only once-daily product available that, based on Aerie’s
preclinical and clinical studies to date, specifically targets the
trabecular meshwork, the eye’s primary fluid drain and the diseased
tissue responsible for elevated intraocular pressure (IOP) in
glaucoma. Preclinical and clinical 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™ may provide an
additional mechanism that reduces fluid production in the eye and
therefore lowers IOP. Biochemically, the active ingredient in
Rhopressa™, netarsudil, 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 of
netarsudil on trabecular meshwork cells and the potential to
increase perfusion of the trabecular meshwork.
The results of two Phase 3 registration trials (Rocket 2 and
Rocket 1) for Rhopressa™ were included in the NDA submission to the
FDA in February 2017. There were two additional Phase 3
registration trials for Rhopressa™, named Rocket 3 and Rocket 4.
Rocket 3 was a small 12-month safety-only study in Canada that was
not necessary for the NDA submission and for which enrollment has
been discontinued. Rocket 4, which was successfully completed in
April 2017, was designed to provide adequate six-month safety data
for regulatory filing purposes in Europe, and was also not
necessary for the NDA submission. The 90-day efficacy results from
Rocket 4 and Mercury 1, the initial Phase 3 registration trial for
Aerie product candidate Roclatan™ (netarsudil/latanoprost
ophthalmic solution) 0.02%/0.005%, were also included in the
Rhopressa™ NDA submission as supportive. The FDA has set the
Prescription Drug User Fee Act (PDUFA) goal date for the completion
of the FDA’s review of the Rhopressa™ NDA for February 28,
2018.
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 current product candidates are
once-daily intraocular pressure lowering therapies with novel
mechanisms of action to treat patients with glaucoma or ocular
hypertension. The NDA (new drug application) for Rhopressa™
(netarsudil ophthalmic solution) 0.02% was submitted to the U.S.
Food and Drug Administration (FDA) in February 2017, and, in May
2017, the FDA set the PDUFA (Prescription Drug User Fee Act) goal
date for the completion of the FDA’s review of the Rhopressa™ NDA
for February 28, 2018. Aerie’s second product candidate, Roclatan™
(netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, which is
a fixed dose combination of Rhopressa™ and widely prescribed PGA
latanoprost, achieved its primary efficacy endpoint in two Phase 3
registration trials, named Mercury 1 and Mercury 2, and also
achieved successful 12-month safety and efficacy results in Mercury
1. The Roclatan™ NDA submission is expected to take place in the
first half of 2018. Aerie is also focused on international
expansion and the development of additional product candidates and
technologies in ophthalmology.
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 and potential future 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
request, obtain and maintain FDA or other regulatory authority
approval of, or other action with respect to, our product
candidates, including the expected timing of, and timing of
regulatory and/or other review of, filings for our product
candidates; our expectations regarding the commercialization and
manufacturing of our product candidates; the potential advantages
of our product candidates; our plans to pursue development of
additional product candidates and technologies in ophthalmology,
including 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, acquire and develop additional ophthalmic products or
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, the receipt of the PDUFA goal date
notification and the FDA advisory committee date do not constitute
FDA approval of the Rhopressa™ NDA, and there can be no assurance
that the FDA will complete its review by the PDUFA goal date, that
the FDA will not require changes or additional data, whether as a
result of recommendations, if any, made by any FDA advisory
committee or otherwise, that must be made or received before it
will approve the NDA, if ever, or that the FDA will approve the
NDA. In addition, 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20171013005021/en/
Aerie PharmaceuticalsRichard Rubino,
908-947-3540rrubino@aeriepharma.comorBurns McClellan, Inc., on
behalf of Aerie PharmaceuticalsInvestorsAmi Bavishi,
212-213-0006abavishi@burnsmc.comorMediaJustin Jackson,
212-213-0006jjackson@burnsmc.com
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