Aerie Pharmaceuticals Provides Update on Timing of NDA Filing for RhopressaTM (netarsudil ophthalmic solution) 0.02%
December 23 2016 - 6:30AM
Business Wire
Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage
pharmaceutical company focused on the discovery, development and
commercialization of first-in-class therapies for the treatment of
glaucoma and other diseases of the eye, today reported that it has
been notified by its third party manufacturing vendor that the
manufacturing line related to RhopressaTM in their Tampa, Florida
facility will not be ready for pre-approval inspection by the FDA
until the end of February 2017. In October 2016, the RhopressaTM
NDA (New Drug Application) was withdrawn due to the contract drug
product manufacturer not being prepared for pre-approval inspection
by the FDA. The contract drug product manufacturer had previously
advised Aerie and the FDA that it expected to be prepared for FDA
inspection in January 2017. The delay apparently does not result
from any new findings, but rather additional time needed to
complete validation of new equipment.
Aerie now expects to resubmit the RhopressaTM NDA filing near
the end of the first quarter of 2017 after receiving notification
from the contract drug product manufacturer that the manufacturing
line related to RhopressaTM at the Tampa, Florida site is
inspection ready.
About Rhopressa™
RhopressaTM (netarsudil ophthalmic solution) 0.02%, is a novel
eye drop that we believe, if approved, would become the only
once-daily product available that, based on Aerie’s preclinical
studies, specifically targets the trabecular meshwork, the eye’s
primary fluid drain and the diseased tissue responsible for
elevated intraocular pressure (IOP) in glaucoma. Preclinical
studies have also demonstrated that RhopressaTM lowers episcleral
venous pressure, which contributes approximately half of IOP in
healthy subjects. Further, based on Aerie’s preclinical studies,
RhopressaTM provides an additional mechanism that reduces fluid
production in the eye and therefore lowers IOP. Biochemically,
RhopressaTM has been shown in Aerie studies to inhibit both Rho
Kinase (ROCK) and norepinephrine transporter (NET). Recent
preclinical studies have also shown that RhopressaTM may have
disease-modifying properties, including an anti-fibrotic effect on
the trabecular meshwork and the potential to increase perfusion of
the trabecular meshwork. Preclinical research is also currently
underway to evaluate the potential neuroprotective benefits of
RhopressaTM.
The results of two Phase 3 registration trials (Rocket 2 and
Rocket 1) for RhopressaTM were included in a NDA filing submitted
to the FDA in the third quarter of 2016 that was withdrawn in
October 2016 due to the contract drug product manufacturer not
being prepared for pre-approval inspection by the FDA, and is now
expected to be resubmitted near the end of the first quarter of
2017. Rocket 2 will represent the pivotal trial, and Rocket 1 will
be supportive. There are two additional Phase 3 registration trials
currently underway for RhopressaTM, named Rocket 3 and Rocket 4.
Rocket 3 is a 12-month safety-only study in Canada that is not
needed for the NDA filing. Rocket 4 is designed to provide adequate
six-month safety data for regulatory filing purposes in Europe, and
is also not needed for the NDA filing. Available data from Rocket 4
and Mercury 1, the initial Phase 3 registration trial for Aerie
product candidate RoclatanTM (netarsudil/latanoprost ophthalmic
solution) 0.02%/0.005%, are expected to be included in the
resubmitted RhopressaTM NDA filing as supportive.
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 lead product candidates are
once-daiIy IOP-lowering therapies with novel mechanisms of action
to treat patients with glaucoma or ocular hypertension. The NDA
filing for RhopressaTM (netarsudil ophthalmic solution) 0.02% was
originally submitted in the third quarter of 2016 and is expected
to be resubmitted near the end of the first quarter of 2017. The
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,
currently has two Phase 3 registration trials underway, named
Mercury 1 and Mercury 2. If these trials are successful, a
RoclatanTM NDA filing is expected to take place near year-end 2017.
Aerie is also focused on 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 U.S. Food and Drug Administration or other regulatory
authority approval of, or other action with respect to, our product
candidates, including the expected resubmission of the NDA filing
for RhopressaTM discussed in this press release; our expectations
regarding the commercialization of our product candidates; our
expectations related to the use of proceeds from our equity and
debt financings; our estimates regarding anticipated capital
requirements and our needs for additional financing; 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; and our
ability to protect our proprietary technology and enforce our
intellectual property rights. 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” in the quarterly and annual
reports that we file with the Securities and Exchange Commission
(SEC). In particular, 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/20161223005013/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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