Aerie Pharmaceuticals Receives Positive CHMP Opinion for Rhokiinsa® in the European Union
September 20 2019 - 6:30AM
Business Wire
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, retinal diseases and other
diseases of the eye 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 Rhokiinsa® (netarsudil
ophthalmic solution) 0.02%. The recommended indication is the
reduction of elevated intraocular pressure in adult patients with
primary open-angle glaucoma or ocular hypertension.
The CHMP positive opinion is a scientific recommendation for
marketing authorisation 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 Rhokiinsa®,” 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 Rhokiinsa® and, if
approved, we plan to submit the MAA for Roclanda®, marketed as
Rocklatan® in the United States, shortly thereafter.”
Rhokiinsa® is currently marketed as Rhopressa® in the United
States and is indicated 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,
retinal diseases and other diseases of the eye. 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, has been approved by the FDA and was launched in the
United States in the second quarter of 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 include statements regarding our
intentions, beliefs, projections, outlook, analyses or current
expectations concerning, among other things: our expectations
regarding the commercialization and manufacturing of Rhopressa® and
Rocklatan® or any current or future product candidates, including
the timing, cost or other aspects of the commercial launch of
Rhopressa® and Rocklatan® or any current or future product
candidates; our commercialization, marketing, manufacturing and
supply management capabilities and strategies; 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 or additional
indications, and any current 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® 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 within and beyond
ophthalmology; 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 regulatory approval of Rhopressa® and
Rocklatan® in jurisdictions outside the United States and there can
be no assurance that we will receive regulatory approval for
Rhopressa® and Rocklatan® in jurisdictions outside the United
States. 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/20190920005191/en/
Media: Tad Heitmann 949-526-8747; theitmann@aeriepharma.com
Investors: Ami Bavishi 908-947-3949; abavishi@aeriepharma.com
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