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 European Commission (EC) has
granted a marketing authorisation for Roclanda® (netarsudil and
latanoprost ophthalmic solution) 0.02%/0.005% for the reduction of
elevated intraocular pressure in adult patients with primary
open-angle glaucoma or ocular hypertension for whom monotherapy
with a prostaglandin or netarsudil provides insufficient IOP
reduction.
The marketing authorisation application (MAA) for Roclanda® was
accepted for review by the European Medicines Agency (EMA) in
January 2020. Aerie received a positive scientific opinion
recommending approval of the Roclanda® MAA from the EMA’s Committee
for Medicinal Products for Human Use (CHMP) in November 2020.
“The receipt of the EC marketing authorisation for Roclanda®,
which is the only fixed-dose combination IOP-lowering therapy with
a prostaglandin analogue that does not include a beta blocker, is
an important regulatory milestone for Aerie on the heels of the
recently reported successful interim topline data from our Mercury
3 clinical trial which demonstrated efficacy that was non-inferior
to Ganfort®,” said Vicente Anido, Jr., Ph.D., Chairman and Chief
Executive Officer at Aerie. “We are preparing for pricing
discussions in Germany while continuing our evaluation of
collaboration opportunities for Europe, and the receipt of this
marketing authorisation represents an important step in furthering
all of those discussions.”
Roclanda® was approved by the U.S. Food and Drug Administration
(FDA) in March 2019 under the trade name Rocklatan® for the
reduction of elevated intraocular pressure in patients with
open-angle glaucoma or ocular hypertension. Rhokiinsa® was granted
a marketing authorisation by the EC in November 2019 for the
reduction of elevated intraocular pressure in adult patients with
primary open-angle glaucoma or ocular hypertension. Rhokiinsa® was
approved by the FDA in December 2017 under the trade name
Rhopressa® for the reduction of elevated intraocular pressure in
patients with open-angle glaucoma or ocular hypertension.
The marketing authorisation is valid in all 27 countries of the
European Union, plus Iceland, Norway and Liechtenstein. As the EC
decision was received after the end of the Brexit transition
period, Aerie will complete a further administrative step in order
to obtain a license in the United Kingdom. No reexamination of
clinical data by the U.K. Medicines and Healthcare Products
Regulatory Agency (MHRA) is expected.
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; 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 any current or future
product candidates, and there can be no assurance that we will
receive FDA approval for any current or future product candidates.
In addition, FDA approval of Rhopressa® and Rocklatan® and the EC
grant of a marketing authorisation for Rhokiinsa® and Roclanda® 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. 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/20210111005071/en/
Media: Tad Heitmann 949-526-8747; theitmann@aeriepharma.com
Investors: Ami Bavishi 908-947-3949; abavishi@aeriepharma.com
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