Aerie Pharmaceuticals Receives Marketing Authorisation of Roclanda® 50 micrograms/ml + 200 micrograms/ml Eye Drops, Solution...
April 19 2021 - 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, ocular surface diseases and
retinal diseases, today announced that Roclanda® 50 micrograms/ml +
200 micrograms/ml Eye Drops, Solution (latanoprost + netarsudil)
(“Roclanda®”) has received marketing authorisation from the
Medicines and Healthcare Products Regulatory Agency (“MHRA”) in
Great Britain. Roclanda® is indicated for the reduction of elevated
intraocular pressure (“IOP”) in adult patients with primary
open-angle glaucoma or ocular hypertension for whom monotherapy
with a prostaglandin or netarsudil provides insufficient IOP
reduction (reference Great Britain Summary of Product
Characteristics).
Roclanda® was granted a marketing authorisation by the European
Commission (“EC”) in January 2021 for the same indication. The EC
marketing authorisation is valid in all 27 countries of the
European Union, plus Iceland, Norway and Liechtenstein. Through the
EC marketing authorisation, Roclanda® is also authorised in
Northern Ireland. As the EC decision was received after the end of
the Brexit transition period, Aerie was required to complete a
further administrative step in order to obtain authorisation in
Great Britain, which has now been granted.
“The authorisation of Roclanda® in Great Britain, the only
fixed-dose combination IOP-lowering therapy with a prostaglandin
analogue that does not include a beta blocker, is another important
regulatory milestone for Aerie on the heels of the receipt of the
EC marketing authorisation for Roclanda® in January,” said Vicente
Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie.
“We continue to evaluate our potential collaboration opportunities
in Europe and this authorisation is another important step in
furthering those discussions.”
Roclanda® was authorised by the U.S. Food and Drug
Administration in March 2019 under the trade name Rocklatan® for
the reduction of elevated IOP 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,
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, and instillation
site pain. 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 product candidates 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
authorisation outside of the United States, and any product
candidates 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®, Rhokiinsa®, Roclanda® or any product
candidates or future product candidates; the timing of and our
ability to request, obtain and maintain FDA or other regulatory
authority authorisation of, or other action with respect to, as
applicable, Rhopressa®, Rocklatan® or any product candidates,
preclinical implants or future product candidates; the potential
advantages of Rhopressa® and Rocklatan® or any product candidates
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 or to develop new intellectual property; and our
expectations regarding strategic operations, including our ability
to in-license or acquire additional ophthalmic products, product
candidates or technologies. In particular, FDA authorisation of
Rhopressa® and Rocklatan®, European Medicines Agency (EMA)
authorisation Rhokiinsa® and Roclanda® and MHRA authorisation of
Roclanda® do not constitute regulatory authorisation of Rhopressa®
and Rocklatan® in other jurisdictions, and there can be no
assurance that we will receive regulatory authorisation for
Rhopressa® and Rocklatan® in such other jurisdictions. In addition,
FDA authorisation of Rhopressa® and Rocklatan® do not constitute
FDA authorisation of our product candidates or any future product
candidates, and there can be no assurance that we will receive FDA
authorisation for our product candidates or any future product
candidates. 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 authorisations 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/20210419005046/en/
Media: Tad Heitmann 949-526-8747; theitmann@aeriepharma.com
Investors: Ami Bavishi 908-947-3949; abavishi@aeriepharma.com
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