Aerie Pharmaceuticals Submits Marketing Authorisation Application for Roclanda® (netarsudil & latanoprost ophthalmic solutio...
December 03 2019 - 6:15AM
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, retinal diseases and other
diseases of the eye today announced that it has submitted the
marketing authorisation application (MAA) for Roclanda® (netarsudil
and latanoprost ophthalmic solution) 0.02%/0.005% with the European
Medicines Agency (EMA). Should the MAA for Roclanda® be accepted
for review by the EMA, an opinion from the Committee for Medicinal
Products for Human Use is expected in approximately 12 months.
Roclanda® is currently marketed in the United States as
Rocklatan®.
The MAA submission for Roclanda® was predicated on the receipt
of a marketing authorisation for Rhokiinsa® (netarsudil ophthalmic
solution) 0.02%, which the European Commission granted in November
2019. Rhokiinsa® is marketed as Rhopressa® in the United
States.
“Our regulatory team and other internal support groups worked
tirelessly to complete the Roclanda® MAA filing so quickly after
the receipt of the Rhokiinsa® marketing authorisation,” said
Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at
Aerie. “In Europe, fixed-dose combinations with prostaglandins are
frequently prescribed for the reduction of intraocular pressure
associated with glaucoma. If approved, the combination of our Rho
kinase inhibitor with a prostaglandin would be a first for Europe,
and we look forward to working with the EMA in the coming months
with the goal of bringing this potential new treatment to patients.
As EMA review of the Roclanda® MAA begins, we will be completing
and analyzing our Mercury 3 study, which compares Roclanda® to the
leading fixed-dose combination product in the European Union. We
expect results from this study will be reported next year, which
should support our pricing and reimbursement activities.”
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, 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 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 our 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®. 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/20191203005049/en/
Media: Tad Heitmann 949-526-8747; theitmann@aeriepharma.com
Investors: Ami Bavishi 908-947-3949;
abavishi@aeriepharma.com
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