Product Approved Ahead of the Scheduled PDUFA Date of February 28,
2018
IRVINE, Calif.--(BUSINESS WIRE)--Dec. 18, 2017--
Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) (Aerie or the Company), 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 and other diseases of the eye, today
announced that the U.S. Food and Drug Administration (FDA) has approved
Rhopressa® (netarsudil ophthalmic solution) 0.02% for the
lowering of elevated intraocular pressure (IOP) in patients with
open-angle glaucoma or ocular hypertension. A link to the full product
label is available on the Aerie website at http://investors.aeriepharma.com.
The FDA approval decision was made two months ahead of the scheduled
PDUFA (Prescription Drug User Fee Act) goal date of February 28, 2018.
“The approval of once-daily Rhopressa® represents the single
greatest achievement in Aerie’s history to date, and represents exciting
news for patients with open-angle glaucoma or ocular hypertension, and
physicians. It is a testament to years of successful research and
development and the incredible talents of our dedicated employees, to
whom we owe much gratitude. We have been preparing for commercialization
for well over a year, and our plans are clear. We will hire our sales
force of 100 sales representatives early in the first quarter of 2018,
and plan to launch by mid-second quarter of 2018. As the 2018 year
progresses, it is our goal to make strides in gaining formulary coverage
for commercial plans, which represent approximately half of the U.S.
market. The other half of the U.S. market is covered through Medicare
Part D, and we expect our formulary presence for this market to commence
in January 2019. We also remain on track to file our Roclatan™ new drug
application to the FDA in second quarter 2018,” said Vicente Anido, Jr.,
Ph.D., Chairman and Chief Executive Officer at Aerie.
Dr. Anido continued, “As we reflect on the Rhopressa® approval,
we pay tribute to Aerie’s late co-founder, Dr. David Epstein. He was a
visionary in the field of glaucoma and always believed in the potential
IOP-lowering benefits of Rho kinase inhibition. This is a fulfillment of
his dream.”
About Rhopressa®
Rhopressa® (netarsudil ophthalmic solution) 0.02%, is a novel
once-daily eye drop for the lowering of elevated intraocular pressure in
patients with open-angle glaucoma or ocular hypertension, and was
approved by the FDA in December 2017. Rhopressa® is believed
to reduce IOP by increasing the outflow of aqueous humor (the fluid
inside the eye) through the trabecular meshwork, the main fluid drain of
the eye. A link to the full product label is available on the Aerie web
site at http://investors.aeriepharma.com.
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 glaucoma and other diseases of the eye.
Aerie's first product, Rhopressa® (netarsudil ophthalmic
solution) 0.02%, for the lowering of intraocular pressure (IOP) in
patients with glaucoma or ocular hypertension, was approved by the U.S.
Food and Drug Administration (FDA) in December 2017. Aerie’s second
product candidate, Roclatan™ (netarsudil/latanoprost ophthalmic
solution) 0.02%/0.005%, which is a fixed dose combination of Rhopressa®
and widely prescribed PGA latanoprost, 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. The Roclatan™ NDA submission is expected to take
place in the second quarter of 2018. Aerie is also focused on global
expansion and the development of additional product candidates and
technologies in ophthalmology.
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: the
success, timing and cost of our ongoing and anticipated preclinical
studies and clinical trials for our current product candidates,
including statements regarding the timing of initiation and completion
of the studies and trials; our expectations regarding the clinical
effectiveness of our product candidates and results of our clinical
trials; the timing of and our ability to request, obtain and maintain
FDA or other regulatory authority approval of, or other action with
respect to, our product candidates, including the expected timing of,
and timing of regulatory and/or other review of, filings for our product
candidates; our expectations regarding the commercialization of our
product candidates; the potential advantages of our product candidates;
our plans to pursue development of our product candidates for additional
indications and other therapeutic opportunities; our plans to explore
possible uses of our existing proprietary compounds beyond glaucoma; 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 or 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 approval of
Roclatan™, and there can be no assurance that we will receive FDA
approval for Roclatan™ or any future product candidates. 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20171218006125/en/
Source: Aerie Pharmaceuticals, Inc.
Aerie Pharmaceuticals
Richard Rubino, 908-947-3540
rrubino@aeriepharma.com
or
Burns
McClellan, Inc., on behalf of Aerie Pharmaceuticals
Investors
Ami
Bavishi, 212-213-0006
abavishi@burnsmc.com
or
Media
Justin
Jackson, 212-213-0006
jjackson@burnsmc.com
