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 the commencement of patient
dosing in its Phase 2 clinical trial designed in accordance with
the requirements of Japan’s PMDA (Pharmaceuticals and Medical
Devices Agency) for potential regulatory submission of netarsudil
ophthalmic solution in Japan. Netarsudil ophthalmic solution 0.02%
is known by the name Rhopressa™ in the United States, for which
there is an FDA (U.S. Food and Drug Administration) PDUFA
(Prescription Drug User Fee Act) goal date of February 28,
2018.
This Phase 2 study will be conducted in the United States,
enrolling Japanese and Japanese-American subjects as a precursor to
Phase 3 trials that are expected to be subsequently conducted in
Japan. The primary objectives of this Phase 2 trial are to evaluate
for (1) non-inferiority the ocular hypotensive activity of two
different dose concentrations of netarsudil ophthalmic solution
relative to placebo over a 28-day period, and (2) the ocular and
systemic safety of netarsudil ophthalmic solution relative to
placebo over that period. Baseline IOP (intraocular pressure)
ranges in the trial are greater than or equal to 15 mmHg
(millimeters of mercury) to less than 35 mmHg for subjects with
open angle glaucoma, and greater than 22 mmHg to less than 35 mmHg
for subjects with ocular hypertension. The study will include three
arms of approximately 60 patients each: a netarsudil ophthalmic
solution 0.02% arm, a netarsudil ophthalmic solution 0.04% arm, and
a placebo arm, all taken once daily in the evening.
“Our global expansion strategy is now in full execution mode for
both Japan and Europe, with the previously announced initiation of
Mercury 3 in Europe. We are excited to commence our journey to
potentially gain approval in Japan for netarsudil ophthalmic
solution. Studies in Japan have shown that Japanese glaucoma
patients experience IOPs that are generally lower than those
experienced in the United States and Europe, hence the IOP ranges
in this study start at 15 mmHg. The Japanese glaucoma market is one
of the largest in the world at approximately $1 billion annually,
and we believe there continues to be substantial unmet need in this
market,” 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 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
second quarter of 2018. Aerie is also focused on global 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 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 of our product candidates; the potential
advantages of our product candidates; our plans to pursue
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 or
acquire 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’s vote
in favor of Rhopressa™ 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 that must be made or received
before it will approve the NDA, if ever, or that the FDA will
approve the NDA. 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/20171116006141/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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