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Aerie Pharmaceuticals Announces Early Notification of FDA Acceptance of NDA Submission for Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% with PDUFA Date Set for March 14, 2019

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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, retina diseases and other diseases of the eye, today reported
that it has received the "Day 74" notification from the U.S. Food and
Drug Administration (FDA) earlier than scheduled, the FDA has completed
its initial 60-day review of the NDA (new drug application) for
Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% and
the FDA has determined that the application is sufficiently complete to
permit a substantive review. The PDUFA (Prescription Drug User Fee Act)
goal date for the completion of the FDA's review of the Roclatan™ NDA is
set for March 14, 2019. This date reflects a standard 10-month review
period and is consistent with management's expectations for the
505(b)(2) filing. The "Day 74" notification indicated that the FDA has
not identified any potential review issues, and did not mention the need
for an advisory committee.

"We are delighted with this positive news on our Roclatan™ NDA, and, if
approved, we expect to be fully prepared to launch Roclatan™ using our
existing sales force, which is already making excellent progress in the
early months of our Rhopressa® launch," said Vicente Anido,
Jr., Ph.D., Chairman and Chief Executive Officer at Aerie.

About Roclatan™

Roclatan™ (netarsudil/latanoprost ophthalmic solution)
0.02%/0.005%, is a once-daily eye drop designed to reduce intraocular
pressure (IOP) in patients with glaucoma or ocular hypertension. It is a
fixed dose combination of Aerie's Rhopressa® (netarsudil
ophthalmic solution) 0.02%, which is currently available in the United
States, and widely-prescribed PGA (prostaglandin analog) latanoprost.
Roclatan™ successfully achieved its primary efficacy endpoint in two
Phase 3 registration trials, named Mercury 1 and Mercury 2, and also
achieved successful 12-month safety and efficacy results in Mercury 1.
Aerie submitted the Roclatan™ New Drug Application (NDA) with the U.S.
Food and Drug Administration (FDA) in May 2018 and, in July 2018, the
FDA set the PDUFA (Prescription Drug User Fee Act) goal date for the
completion of the FDA's review of the Roclatan™ NDA for March 14, 2019.
A third Phase 3 trial for Roclatan™, named Mercury 3, is currently
underway in Europe but is not required for approval in the United States.

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, retina diseases and
other diseases of the eye. Aerie's first product, Rhopressa® (netarsudil
ophthalmic solution) 0.02%, a once-daily eyedrop 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, cornea verticillata, instillation
site pain, and conjunctival hemorrhage. More information about Rhopressa®,
including the product label, is available at www.rhopressa.com.
Aerie's advanced-stage product candidate,
Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, a
fixed-dose combination of Rhopressa® and the
widely-prescribed PGA (prostaglandin analog) latanoprost, achieved its
3-month primary efficacy endpoint in two Phase 3 registration trials,
Mercury 1 and Mercury 2, and also showed safety and efficacy throughout
12 months in Mercury 1. Aerie submitted the Roclatan™ New Drug
Application (NDA) in May 2018 and, in July 2018, the FDA set the PDUFA
(Prescription Drug User Fee Act) goal date for the completion of the
FDA's review of the Roclatan™ NDA for March 14, 2019. 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 commercial launch and sales of Rhopressa®
and Roclatan™ and any future product candidates, if approved; our
commercialization, marketing, manufacturing and supply management
capabilities and strategies; third-party payer coverage and
reimbursement of Rhopressa® and Roclatan™ and any future
product candidates, if approved; the glaucoma patient market size and
the rate and degree of market adoption of Rhopressa® and
Roclatan™ and any future product candidates, if approved, by eye-care
professionals and patients; the timing cost or other aspects of the
commercial launch of Rhopressa® and Roclatan™ and any future
product candidates, if approved; the success, timing and cost of our
ongoing and anticipated preclinical studies and clinical trials for
Rhopressa®, with respect to regulatory approval outside the
United States, and Roclatan™ and any future product candidates,
including statements regarding the timing of initiation and completion
of the studies and trials; our expectations regarding the effectiveness
of Rhopressa®, Roclatan™ and any future product candidates
and results of our clinical trials and any potential preclinical
studies; 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®, Roclatan™
and any future product candidates in the United States, Canada, Europe,
Japan and elsewhere, including the expected timing of, and regulatory
and/or other review of, filings for, as applicable, Rhopressa®,
Roclatan™ and any future product candidates; the potential advantages of
Rhopressa®, Roclatan™ and any future product
candidates; our plans to pursue development of additional product
candidates and technologies in ophthalmology, including development of
Rhopressa® and Roclatan™ for additional indications, our
preclinical retina programs and other therapeutic opportunities; our
plans to explore possible uses of our existing proprietary compounds
beyond glaucoma and ophthalmology; our ability to protect our
proprietary technology and enforce our intellectual property rights; and
our expectations regarding collaborations, licensing, acquisitions and
strategic operations, including our ability to in-license or acquire
additional ophthalmic products, product candidates or technologies. 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). In particular, FDA
approval of Rhopressa® does not constitute FDA approval of
Roclatan™, and there can be no assurance that we will receive FDA
approval for Roclatan™ on the timeframe discussed in this press release,
if at all, or for any future product candidates. FDA approval of
Rhopressa® also does not constitute regulatory approval of
Rhopressa® in jurisdictions outside the United States, and
there can be no assurance that Rhopressa® will obtain
regulatory approval in other jurisdictions. 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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