-European Commission Decision Anticipated in
Approximately Two Months-
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 Medicines Agency’s
(EMA) Committee for Medicinal Products for Human Use (CHMP) has
adopted a positive opinion recommending approval of the marketing
authorisation application (MAA) for Roclanda® (netarsudil and
latanoprost ophthalmic solution) 0.02%/0.005%. The recommended
indication is 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 CHMP positive opinion is a scientific recommendation for
marketing authorisation, which is referred to the European
Commission for a final decision on the Company’s MAA. The final
decision is expected in approximately two months and will be
applicable to all European Union member states plus Iceland, Norway
and Liechtenstein.
“We are delighted that the CHMP has adopted a positive opinion
for Roclanda®,” said Vicente Anido, Jr., Ph.D., Chairman and Chief
Executive Officer at Aerie. “We look forward to the European
Commission’s final decision on the MAA for Roclanda®, which is
expected by early next year.”
Roclanda® is currently marketed as Rocklatan® in the United
States and is indicated for the reduction of elevated intraocular
pressure in patients with open-angle glaucoma or 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 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 future product
candidates, and there can be no assurance that we will receive FDA
approval for any future product candidates. In addition, FDA
approval of Rhopressa® and Rocklatan® and EMA approval of
Rhokiinsa® do not constitute regulatory approval of Rhopressa® and
Rocklatan® in other jurisdictions, including EMA approval of
Roclanda®, and there can be no assurance that we will receive
regulatory approval for Rhopressa® and Rocklatan® in such other
jurisdictions, including EMA approval of Roclanda®. Furthermore,
EMA acceptance of the MAA for Roclanda® and the CHMP opinion of
Roclanda® do not constitute EMA approval of Roclanda®, and there
can be no assurance that we will receive EMA approval of Roclanda®.
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/20201113005354/en/
Media: Tad Heitmann 949-526-8747; theitmann@aeriepharma.com
Investors: Ami Bavishi 908-947-3949; abavishi@aeriepharma.com
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