Topline results expected in the fourth quarter
of 2021
Aerie Pharmaceuticals, Inc. (NASDAQ: AERI), an ophthalmic
pharmaceutical company focused on the discovery, development and
commercialization of first-in-class therapies for the treatment of
patients with open-angle glaucoma, ocular surface diseases and
retinal diseases, today announced the completion of patient
enrollment for its first Phase 3 clinical trial of netarsudil
ophthalmic solution in Japan, comparing netarsudil ophthalmic
solution 0.02% (“netarsudil”), administered once a day in the
evening, to ripasudil hydrochloride hydrate ophthalmic solution
0.4% (“ripasudil”), marketed as Glanatec® in Japan, administered
twice a day, in the morning and evening.
The first patient to enter this randomized, single-masked,
multi-center, parallel-group Phase 3 study was dosed in early
December 2020. A total of 245 patients were successfully randomized
across the netarsudil and ripasudil treatment arms. The netarsudil
arm includes a netarsudil drop in the evening and netarsudil
ophthalmic solution vehicle administered in the morning to preserve
the masking of the trial. The ripasudil arm is administered twice a
day, once in the morning and once in the evening, consistent with
the product labeling in Japan.
“We are pleased that our clinical activities in Japan continue
to advance with the completion of enrollment in this first Phase 3
clinical trial. As we have stated previously, we expect to conduct
a total of three Phase 3 clinical trials for Rhopressa® in Japan,
two 4-week trials and one 12-month safety trial. We currently
expect to complete the first Phase 3 clinical trial by the end of
2021 and expect to report topline results from the trial shortly
thereafter,” stated Vicente Anido, Jr., Ph.D., Chairman and Chief
Executive Officer at Aerie.
Aerie and Santen Pharmaceutical Co., Ltd. (“Santen”) announced
an exclusive collaboration and license agreement for Rhopressa® and
Rocklatan® in Japan and several other Asian countries in October
2020. As part of this agreement, Santen is responsible for all
development and commercialization costs and activities related to
the products in the territories covered by the agreement; however,
Aerie and Santen have collaborated for this first Phase 3 study for
Rhopressa® in Japan, which they are co-funding.
The study was designed in accordance with the requirements of
Japan’s Pharmaceuticals and Medical Devices Agency (“PMDA”) to
support a potential regulatory submission of netarsudil ophthalmic
solution in Japan. The objective of the study, a superiority study,
is to evaluate the ocular hypotensive efficacy and safety of
netarsudil once daily compared to ripasudil twice daily, over a
4-week period in patients with primary open-angle glaucoma or
ocular hypertension. More information about the study is available
at www.clinicaltrials.gov under the study designation
NCT04620135.
Netarsudil is marketed as Rhopressa® in the United States where
it is approved for the reduction of elevated intraocular pressure
in patients with open-angle glaucoma or ocular hypertension.
About Aerie Pharmaceuticals, Inc.
Aerie is an ophthalmic pharmaceutical company focused on the
discovery, development and commercialization of first-in-class
therapies for the treatment of patients with open-angle glaucoma,
ocular surface diseases and retinal diseases. Aerie’s first
product, Rhopressa® (netarsudil ophthalmic solution) 0.02%, a
once-daily eye drop approved by the U.S. Food and Drug
Administration (FDA) for the reduction of elevated intraocular
pressure (IOP) in patients with open-angle glaucoma or ocular
hypertension, was launched in the United States in April 2018. In
clinical trials of Rhopressa®, the most common adverse reactions
were conjunctival hyperemia, corneal verticillata, instillation
site pain, and conjunctival hemorrhage. More information about
Rhopressa®, including the product label, is available at
www.rhopressa.com. Aerie’s second product for the reduction of
elevated IOP in patients with open-angle glaucoma or ocular
hypertension, Rocklatan® (netarsudil and latanoprost ophthalmic
solution) 0.02%/0.005%, the first and only fixed-dose combination
of Rhopressa® and the widely-prescribed PGA (prostaglandin analog)
latanoprost, was launched in the United States in May 2019. In
clinical trials of Rocklatan®, the most common adverse reactions
were conjunctival hyperemia, corneal verticillata, instillation
site pain, and conjunctival hemorrhage. More information about
Rocklatan®, including the product label, is available at
www.rocklatan.com. Aerie continues to focus on global expansion and
the development of additional product candidates and technologies
in ophthalmology, including for wet age-related macular
degeneration and diabetic macular edema. More information is
available at www.aeriepharma.com.
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 in this release include statements
regarding our intentions, beliefs, projections, outlook, analyses
or current expectations concerning, among other things: the
duration and severity of the coronavirus disease (COVID-19)
outbreak, including the impact on our clinical and commercial
operations, demand for our products and financial results and
condition of our global supply chains; our expectations regarding
the commercialization and manufacturing of Rhopressa®, Rocklatan®,
Rhokiinsa® and Roclanda® or any product candidates or future
product candidates, including the timing, cost or other aspects of
their commercial launch; our commercialization, marketing,
manufacturing and supply management capabilities and strategies in
and outside of the United States; the success, timing and cost of
our ongoing and anticipated preclinical studies and clinical trials
for Rhopressa® and Rocklatan®, with respect to regulatory approval
outside of the United States, and any product candidates or future
product candidates, including statements regarding the timing of
initiation and completion of the studies and trials; our
expectations regarding the effectiveness of Rhopressa®, Rocklatan®,
Rhokiinsa®, Roclanda® or any product candidates or future product
candidates; the timing of and our ability to request, obtain and
maintain FDA or other regulatory authority approval of, or other
action with respect to, as applicable, Rhopressa®, Rocklatan® or
any product candidates, preclinical implants or future product
candidates; the potential advantages of Rhopressa® and Rocklatan®
or any product candidates or future product candidates; our plans
to pursue development of additional product candidates and
technologies; our plans to explore possible uses of our existing
proprietary compounds beyond glaucoma, including development of our
retina program; our ability to protect our proprietary technology
and enforce our intellectual property rights or to develop new
intellectual property; and our expectations regarding strategic
operations, including our ability to in-license or acquire
additional ophthalmic products, product candidates or technologies.
In particular, FDA and European Medicines Agency (EMA) approval of
Rhopressa® and Rocklatan® do not constitute regulatory approval of
Rhopressa® and Rocklatan® in other jurisdictions, and there can be
no assurance that we will receive regulatory approval for
Rhopressa® and Rocklatan® in such other jurisdictions, including
Japan’s PMDA. In addition, FDA approval of Rhopressa® and
Rocklatan® do not constitute FDA approval of our product candidates
or any future product candidates, and there can be no assurance
that we will receive FDA approval for our product candidates or any
future product candidates. 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).
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: https://www.businesswire.com/news/home/20210617005036/en/
Media: Tad Heitmann 949-526-8747; theitmann@aeriepharma.com
Investors: Ami Bavishi 908-947-3949; abavishi@aeriepharma.com
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