– First and Only Once-Daily, Fixed-Dose
Combination of a Prostaglandin Analog and a Rho Kinase (ROCK)
Inhibitor –
– Rocklatan™ Demonstrated Statistical
Superiority over Widely-Prescribed First-Line Agent Latanoprost
–
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,
retinal diseases and other diseases of the eye, today announced
that the U.S. Food and Drug Administration (FDA) has approved
Rocklatan™ (netarsudil and latanoprost ophthalmic solution)
0.02%/0.005% to reduce 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.
Rocklatan™ is a once-daily eye drop that is a fixed-dose
combination of latanoprost, the most widely-prescribed
prostaglandin analog (PGA), and netarsudil, the active ingredient
in Rhopressa® (netarsudil ophthalmic solution) 0.02%, a
first-in-class Rho kinase (ROCK) inhibitor specifically designed to
target the trabecular meshwork (the eye’s principal drainage
pathway). The diseased trabecular meshwork is considered to be the
main cause of elevated IOP in open-angle glaucoma and ocular
hypertension. Rhopressa® works by restoring outflow through the
trabecular meshwork, while latanoprost increases fluid outflow
through a secondary mechanism known as the uveoscleral pathway.
Aerie launched Rhopressa® in the United States in April 2018.
The Company plans to launch Rocklatan™ in the United States in the
second quarter of 2019.
“We are in the unique position of receiving FDA approval on a
second glaucoma treatment less than a year from the U.S. launch of
Rhopressa®,” said Vicente Anido, Jr., Ph.D., chairman and chief
executive officer at Aerie. “Together, Rocklatan™ and Rhopressa®
give us a broad therapeutic franchise, based on our ROCK inhibitor
netarsudil, that addresses many of the needs of clinicians and
patients in a wide variety of treatment settings. Our existing
salesforce, which has been calling on U.S. eye-care professionals
since last May, is very well positioned to introduce Rocklatan™ to
these doctors and help them understand the clinical utility of both
products in the care of their patients with glaucoma. We have also
been working diligently on securing favorable reimbursement for our
products, with Rhopressa® now enjoying broad commercial and
Medicare Part D coverage, and Rocklatan™ already under review by
major payers.”
The FDA approval of Rocklatan™ is based on data from two Phase 3
registration trials, MERCURY 1 and MERCURY 2. In these studies,
Rocklatan™ achieved its primary 90-day efficacy endpoint as well as
positive 12-month safety and efficacy results, demonstrating
statistically superior IOP reduction over latanoprost and
netarsudil at every measured time point. More than 60% of patients
taking Rocklatan™ in the two MERCURY studies achieved an IOP
reduction of 30% or more, a frequency that was nearly twice that
achieved by participants taking latanoprost alone. Rocklatan™ also
helped more patients get to low target pressures. Nearly twice as
many patients taking Rocklatan™ reached 16 mmHg or lower and nearly
three times as many reached 14 mmHg or lower compared to
latanoprost.
In the two MERCURY studies, Rocklatan™ treatment was associated
with generally mild and tolerable ocular adverse events, with
minimal systemic side effects. The most common ocular adverse event
in controlled clinical studies with Rocklatan™ was conjunctival
hyperemia. Ninety percent of patients who experienced hyperemia
reported it as mild and 5% discontinued because of it. Other common
ocular adverse effects reported in the studies include instillation
site pain, corneal verticillata and conjunctival hemorrhage.
About Rocklatan™
Indications and Usage
ROCKLATAN™ (netarsudil and latanoprost ophthalmic solution)
0.02%/0.005% is indicated for the reduction of elevated intraocular
pressure (IOP) in patients with open-angle glaucoma or ocular
hypertension.
Select Important Safety Information
Although not observed in the two MERCURY studies, latanoprost
has been reported to cause changes to pigmented tissues, including
pigmentation of the iris, periorbital tissue (eyelid) and
eyelashes. Iris pigmentation is likely to be permanent. Latanoprost
has also been associated with gradual changes to eyelashes
including increased length, thickness and number of lashes. These
changes are usually reversable.
About Glaucoma
Glaucoma is a disease that causes damage to the optic nerve. It
is characterized by progressive degeneration of retinal cells,
resulting in irreversible vision loss and, potentially, blindness.
At least 60 million people worldwide are thought to be affected.
The National Eye Institute estimates that more than 2.7 million
people in the United States suffer from glaucoma, a number expected
to reach 4.3 million by 2030. Furthermore, The Eye Diseases
Prevalence Research Group has estimated that only half of Americans
with glaucoma know they have the disease. As a result, glaucoma
remains a leading cause of adult blindness but, with diagnosis and
effective treatment, is also one of the most preventable.
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 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, 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, 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 is expected to be launched in the United States in the
second quarter of 2019. 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 future product candidates, including the timing,
cost or other aspects of the commercial launch of Rhopressa® and
Rocklatan™ or any 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 future product
candidates, including statements regarding the timing of initiation
and completion of the studies and 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, as
applicable, Rhopressa®, Rocklatan™ or any 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 future product candidates; the
potential advantages of Rhopressa® and Rocklatan™ or any 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. 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® and Rocklatan™ do not constitute FDA approval of
AR-1105, AR-13503 or any future product candidates, and there can
be no assurance that we will receive FDA approval for AR-1105,
AR-13503 or any future product candidates. FDA approval of
Rhopressa® and Rocklatan™ also do not constitute regulatory
approval of Rhopressa® and Rocklatan™ in jurisdictions outside the
United States and there can be no assurance that we will receive
regulatory approval for Rhopressa® and Rocklatan™ in jurisdictions
outside the United States. 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/20190312005935/en/
Media: Tad Heitmann 949-526-8747;
theitmann@aeriepharma.comInvestors: Ami Bavishi 908-947-3949;
abavishi@aeriepharma.com
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