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, in their review of Aerie
product candidate RhopressaTM (netarsudil ophthalmic solution)
0.02%, the members of Dermatologic and Ophthalmic Drugs Advisory
Committee of the U.S. Food and Drug Administration (FDA) voted as
follows on the two points for Advisory Committee consideration:
1. Do the clinical trials support the efficacy of netarsudil
ophthalmic solution for reducing elevated intraocular pressure in
patients with open-angle glaucoma or ocular hypertension?
Results: (10-0) There were ten yes votes and zero no votes.
2. Does the efficacy of netarsudil ophthalmic solution,
demonstrated in the clinical trials, outweigh the safety risks
identified for the drug product?
Results: (9-1) There were nine yes votes and one no vote.
In addition, there was general discussion on suggestions
regarding the draft product labeling proposed by the FDA, which
will ultimately be determined based on follow-on discussions
between Aerie and the FDA.
The goal date for the FDA to take action under the Prescription
Drug User Fee Act (PDUFA) is February 28, 2018. The FDA is not
bound by the Advisory Committee's guidance, but takes its advice
into consideration when reviewing investigational medicines.
“We are delighted with the outcome of the FDA’s Advisory
Committee, and we now have our sights set on the February 28th
PDUFA date. We believe there are significant unmet needs in the
treatment of patients with open-angle glaucoma or ocular
hypertension, and we are very excited about the prospects for
RhopressaTM,” said Vicente Anido, Jr., Ph.D., Chairman and Chief
Executive Officer at Aerie.
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 (new drug
application) 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 RhopressaTM
(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 RhopressaTM NDA
for February 28, 2018. Aerie’s 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, 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 RoclatanTM 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 FDA advisory committee’s vote in favor of
RhopressaTM do not constitute FDA approval of the RhopressaTM 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 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/20171013005587/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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