-First Patient Dosed in 90-Day Efficacy Trial
Named COMET-1-
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 commencement of COMET-1, a
Phase 2b clinical trial of AR-15512 (TRPM8 agonist) ophthalmic
solution for the treatment of patients with dry eye disease.
The COMET-1 trial is a randomized, double-masked,
vehicle-controlled trial evaluating the efficacy and safety of
AR-15512 (TRPM8 agonist) in patients with dry eye disease.
Approximately 360 patients in total are expected to be enrolled.
Patients will receive either AR-15512 0.0014%, AR-15512 0.003% or
AR-15512 vehicle dosed as one drop twice daily in each eye over
three months. The primary efficacy endpoints of the clinical trial
are ocular discomfort (symptom) and tear production (sign).
Patients will be evaluated on multiple efficacy assessments at days
14, 28 and 84; safety will be assessed at all visits. Topline
results from COMET-1 are expected in the third quarter of 2021.
More information about the clinical trial is available at
www.clinicaltrials.gov under the study designation NCT04498182.
“We are excited to initiate COMET-1, Aerie’s first dry eye
clinical trial,” said Vicente Anido, Jr., Ph.D., Chairman and Chief
Executive Officer at Aerie. “With an estimated 30 million dry eye
sufferers in the United States and less than 3 million treated, we
believe there is a substantial unmet need in the treatment of dry
eye disease. By activating the TRPM8 receptor, AR-15512 may
stimulate tear production as well as reduce ocular discomfort
through a mild cooling sensation. We anticipate topline results of
COMET-1, which is powered as a Phase 3, in the third quarter of
2021.”
AR-15512, formerly AVX-012, was acquired by Aerie in November
2019 in the acquisition of Avizorex Pharma, S.L., a Spanish
ophthalmic pharmaceutical company developing therapeutics for the
treatment of dry eye disease.
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 current 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 current or future product candidates,
including statements regarding the timing of initiation and
completion of the studies and trials, such as statements in this
press release regarding any expected clinical trials for AR-15512
(formerly AVX-012), AR-1105 or AR-13503 and the results of such
clinical trials; our expectations regarding the effectiveness of
Rhopressa®, Rocklatan®, Rhokiinsa®, Roclanda® or any current 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 current or future product candidates,
including the expected timing of, and timing of regulatory and/or
other review of, filings for, as applicable, Rhopressa®, Rocklatan®
or any current or future product candidates; the potential
advantages of Rhopressa® and Rocklatan® or any current 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; and our expectations regarding strategic operations,
including our ability to in-license or acquire additional
ophthalmic products, product candidates or technologies. In
particular, FDA approval of Rhopressa® and Rocklatan® do not
constitute FDA approval of AR-15512, AR-1105 or AR-13503 or any
future product candidates, and there can be no assurance that we
will receive FDA approval for AR-15512, AR-1105 or AR-13503 or any
future product candidates. In addition, the initiation of the
clinical trial discussed in this press release does not constitute
FDA approval of AR-15512 and the outcome of later clinical trials
for AR-15512, including the clinical trial discussed in this press
release, may not be sufficient to submit an NDA with the FDA or to
receive FDA approval. 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/20201029005080/en/
Media: Tad Heitmann 949-526-8747; theitmann@aeriepharma.com
Investors: Ami Bavishi 908-947-3949; abavishi@aeriepharma.com
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