IRVINE, Calif.--(BUSINESS WIRE)--Oct. 13, 2017--
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20171013005587/en/
Source: Aerie Pharmaceuticals, Inc.
Aerie Pharmaceuticals
Richard Rubino, 908-947-3540
rrubino@aeriepharma.com
or
Burns
McClellan, Inc., on behalf of Aerie Pharmaceuticals
Investors
Ami
Bavishi, 212-213-0006
abavishi@burnsmc.com
or
Media
Justin
Jackson, 212-213-0006
jjackson@burnsmc.com
