Aerie Pharmaceuticals Announces U.S. Food & Drug Administration Approval of its Athlone, Ireland Facility for Production of R...
September 15 2020 - 6:45AM
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 its sterile fill production
facility in Athlone, Ireland has received approval from the U.S.
Food and Drug Administration (FDA) for production of Rhopressa®
(netarsudil ophthalmic solution) 0.02% for commercial distribution
in the United States. This approval comes following the FDA review
of the New Drug Application Prior Approval Supplement (PAS), which
added the Athlone production facility as a drug product
manufacturer for Rhopressa®.
“The PAS approval for Rhopressa® represents another important
manufacturing achievement for Aerie in 2020,” said Vicente Anido,
Jr., Ph.D., Chairman and Chief Executive Officer at Aerie. “What
began as a vision to control our destiny from a manufacturing
standpoint in 2015 has led to the FDA approval of our facility
earlier this year to produce Rocklatan®, and now Rhopressa®, for
commercial distribution in the United States. We started shipping
Rocklatan® to the United States earlier in the third quarter of
2020 and have also manufactured supplies of Rhopressa® for our
upcoming Phase 3 clinical trials in Japan. Additionally, we expect
to begin shipping Rhopressa® to the United States in the fourth
quarter of 2020 as we continue to work towards the goal of having
our Athlone facility supply our ophthalmic products for all markets
in which we plan to operate.”
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,
including statements regarding the timing of initiation and
completion of the studies and trials, such as statements in this
press release regarding any expected clinical trials for AR-15512
(formerly AVX-012), AR-1105 or AR-13503 and the results of such
clinical trials; 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, statements in this press release regarding our Athlone,
Ireland facility are forward looking statements. 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®. Additionally,
FDA approval of Rhopressa® and Rocklatan® do not constitute FDA
approval of our current or any future product candidates, and there
can be no assurance that we will receive FDA approval for our
current or any future product candidates. Furthermore, EMA
acceptance of the MAA for Roclanda® does not constitute EMA
approval of Roclanda®, and there can be no assurance that we will
receive EMA approval of Roclanda®. In addition, the acceptance of
the INDs by the FDA for AR-15512, AR-1105 and AR-13503 do not
constitute FDA approval of AR-15512, AR-1105 or AR-13503 and the
outcomes of later clinical trials for AR-15512, AR-1105 or AR-13503
may not be sufficient to submit an NDA with the FDA or to receive
FDA approval. 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/20200915005132/en/
Media: Tad Heitmann 949-526-8747; theitmann@aeriepharma.com
Investors: Ami Bavishi 908-947-3949; abavishi@aeriepharma.com
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