Aerie Pharmaceuticals Announces Acceptance for Review of the Roclanda® (netarsudil & latanoprost ophthalmic solution) 0.02%/...
January 02 2020 - 6:30AM
Business Wire
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, dry eye, retinal diseases and
other diseases of the eye today announced that the European
Medicines Agency (EMA) has accepted for review the marketing
authorisation application (MAA) for Roclanda ® (netarsudil and
latanoprost ophthalmic solution) 0.02%/0.005%. Roclanda® is
currently marketed as Rocklatan® in the United States, where it is
indicated for the reduction of elevated intraocular pressure in
patients with open-angle glaucoma or ocular hypertension. An
opinion from the EMA’s Committee for Medicinal Products for Human
Use on the MAA for Roclanda® is expected in late 2020.
“We are delighted that the European regulatory authorities have
accepted our Roclanda® filing for review. If approved, Roclanda®,
the combination of our Rho kinase inhibitor with a prostaglandin
analog, would be the first fixed-dose combination of its kind in
Europe,” said Vicente Anido, Jr., Ph.D., Chairman and Chief
Executive Officer at Aerie. “As EMA review continues of the
Roclanda® MAA, we expect to complete and analyze our Mercury 3
study in the second half of 2020. The Mercury 3 study, which
compares Roclanda® to the leading fixed-dose combination product in
Europe, is not a requirement for EMA approval, but rather is
designed to support pricing and reimbursement activities in
Europe.”
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,
dry eye, 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, was 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 dry eye, 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, as
applicable, Rhopressa®, Rocklatan®, Rhokiinsa®, Roclanda® or any
current or future product candidates, including the timing, cost or
other aspects of their commercial launch or commercialization,
marketing, manufacturing and supply management capabilities and
strategies in and outside 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 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®, Rhokiinsa®, Roclanda® 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® 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®. In
addition, EMA acceptance of the MAA for Roclanda® does not
constitute regulatory approval of Roclanda® by the EMA, and there
can be no assurance that we will receive regulatory approval of
Roclanda® by the EMA. 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/20200102005043/en/
Media: Tad Heitmann 949-526-8747; theitmann@aeriepharma.com
Investors: Ami Bavishi 908-947-3949; abavishi@aeriepharma.com
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