Topline results expected in the third 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 COMET-1, a Phase 2b clinical trial of AR-15512
(TRPM8 Agonist) (“AR-15512”) ophthalmic solution for the treatment
of patients with dry eye disease.
The first patient to enter this randomized, double-masked,
vehicle-controlled Phase 2b clinical trial evaluating the efficacy
and safety of AR-15512 in patients with dry eye disease was dosed
in October 2020. A total of 369 patients were randomized across
three arms, AR-15512 (0.0014%), AR-15512 (0.003%) or AR-15512
vehicle. Patients were given one drop twice daily in each eye over
three months. Patients are evaluated at days 14, 28 and 84, with
the primary efficacy measures of ocular discomfort (a symptom) and
tear production (a sign). The regulatory pathway for dry eye
product approval requires that both safety and efficacy need to be
demonstrated in at least 2 well-controlled clinical trials.
Efficacy for sign and symptom do not need to be shown in the same
trial but both have to be shown in multiple trials. More
information about the clinical trial is available at
www.clinicaltrials.gov under the study designation NCT04498182.
“With an estimated 30 million dry eye sufferers in the United
States and less than 3 million treated, there remains a significant
unmet need in the treatment of dry eye disease. When activated, the
TRPM8 receptor may increase tear production, a sign for dry eye
disease, and its cooling sensation may lead to reduction in
discomfort and ocular pain, a symptom of dry eye disease. This
unique mechanism of action targeting both the signs and symptoms of
dry eye disease is different from currently marketed eye products
and we believe has the potential for use as a monotherapy and in
conjunction with other approved products,” said Vicente Anido, Jr.,
Ph.D., Chairman and Chief Executive Officer at Aerie. “We are
pleased that our dry eye clinical activities continue to advance
with the completion of enrollment in this Phase 2b clinical trial,
COMET-1. We currently expect to report topline results for this
trial in the third quarter of this year.”
AR-15512, formerly AVX-012, was acquired by Aerie in November
2019 in connection with the acquisition of Avizorex Pharma, S.L., a
Spanish ophthalmic pharmaceutical company developing therapeutics
for the treatment of dry eye disease. AR-15512 has intellectual
property protection for pharmaceutical composition and method of
use through 2031.
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, including
AR-15512, or other 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, including AR-15512, 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, including
AR-15512, or other 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, including AR-15512, 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/20210429005235/en/
Media: Tad Heitmann 949-526-8747; theitmann@aeriepharma.com
Investors: Ami Bavishi 908-947-3949; abavishi@aeriepharma.com
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