DURHAM, N.C.--(BUSINESS WIRE)--Apr. 30, 2018--
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 and other diseases of the eye, today announced that it has
launched Rhopressa® in the United States. Rhopressa®
is now in national and regional U.S. pharmaceutical distributors, and
patients have access to Rhopressa® through their local
pharmacies across the nation.
“We are pleased to announce the availability in the United States of
Rhopressa®, the first new drug class in more than two decades
for the reduction of intraocular pressure in patients with glaucoma or
ocular hypertension. Our national sales force is fully trained,
deployed, and already providing product information and samples to
physicians. Formulary contracts for commercial insurance coverage in
2018 and Medicare Part D program coverage beginning in 2019 are in the
final stages of being executed. In addition, through the availability of
a co-pay savings card program, all patients covered by commercial
insurance will have immediate access to Rhopressa®. Aerie has
also proactively engaged the major e-prescribing platforms to ensure
physicians are able to prescribe Rhopressa® electronically
for their patients. We look forward to providing additional details as
part of our business update during our first-quarter 2018 financial
results call scheduled for May 8, 2018,” said Vicente Anido, Jr., Ph.D.,
Chairman and Chief Executive Officer.
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 glaucoma and ocular hypertension, and was approved by the
FDA in December 2017. Rhopressa® is specifically designed to
increase 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 open-angle glaucoma and other diseases of the
eye. Aerie's first product, Rhopressa® (netarsudil ophthalmic
solution) 0.02%, for the reduction of elevated intraocular pressure
(IOP) in patients with open-angle glaucoma or ocular hypertension, was
approved by the U.S. Food and Drug Administration (FDA) in December 2017
and was launched in the U.S. market in April 2018. A link to the full
product label is available on the Aerie website at http://investors.aeriepharma.com.
Aerie’s advanced-stage product candidate, RoclatanTM
(netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, which is a
fixed dose combination of Rhopressa® and widely-prescribed
PGA (prostaglandin analog) 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 RoclatanTM 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: our
expectations regarding the commercial launch and potential future sales
of Rhopressa® and RoclatanTM 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 RoclatanTM and any future product candidates, if
approved; the glaucoma patient market size and the rate and degree of
market adoption of Rhopressa® and RoclatanTM 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 RoclatanTM 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 RoclatanTM 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®, RoclatanTM 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®,RoclatanTM
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®,
RoclatanTM and any future product candidates; the potential
advantages of Rhopressa®,RoclatanTM
and any future product candidates; our plans to pursue development of
additional product candidates and technologies in ophthalmology,
including development of Rhopressa® and RoclatanTM
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
RoclatanTM, and there can be no assurance that we will
receive FDA approval for RoclatanTM or 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180430005006/en/
Source: Aerie Pharmaceuticals, Inc.
Aerie Pharmaceuticals
Media:
Tad
Heitmann, 949-526-8747
theitmann@aeriepharma.com
or
Investors:
Richard
Rubino, 908-947-3540
rrubino@aeriepharma.com
or
Burns
McClellan, Inc., on behalf of Aerie Pharmaceuticals
Media:
Justin
Jackson, 212-213-0006
jjackson@burnsmc.com
or
Investors:
Ami
Bavishi, 212-213-0006
abavishi@burnsmc.com
