Aerie Pharmaceuticals Submits Prior Approval Supplement to the U.S. Food & Drug Administration to Allow Production of Rocklat...
September 19 2019 - 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, retinal diseases and other
diseases of the eye today announced the submission of a prior
approval supplement (PAS) to the U.S. Food and Drug Administration
(FDA). If approved, the PAS will permit production of Rocklatan®
(netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% for
sale in the United States in Aerie’s new manufacturing plant in
Athlone, Ireland.
“Along with the successful GMP inspection and authorization of
the Athlone plant for product manufacturing by Ireland’s Health
Products Regulatory Authority (HPRA), we have also successfully
executed process validation studies for Rocklatan® and generated
stability data to support registration of the Athlone plant with
the FDA,” said Vicente Anido, Jr., Ph.D., Chairman and Chief
Executive Officer. “Our PAS submission is another milestone for
Aerie as we continue to move towards having our state-of-the-art
plant facilitate the global supply of Aerie products.”
Based on FDA timelines, Aerie expects the PAS filing review to
be completed within 60 days, with final PAS review in 4 months. In
addition, the Company anticipates a preapproval inspection of the
Athlone manufacturing plant during the 4-month review. A successful
inspection along with FDA approval of the supplement would allow
Rocklatan® to be manufactured in Athlone for sale in the United
States in the first half of 2020. The Company also plans to file a
PAS in the first half of 2020 to obtain FDA approval to manufacture
Rhopressa® (netarsudil ophthalmic solution) 0.02% in Athlone.
Rocklatan® was approved by the FDA in the United States on March
12, 2019 and the commercial launch in the United States occurred on
May 1, 2019.
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 permission to manufacture Rhopressa®
and Rocklatan® by us and there can be no assurance that we will
receive permission to manufacture Rhopressa® and Rocklatan®. 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/20190919005174/en/
Media: Tad Heitmann 949-526-8747; theitmann@aeriepharma.com
Investors: Ami Bavishi 908-947-3949; abavishi@aeriepharma.com
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