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 that it has launched
Rocklatan® (netarsudil and latanoprost ophthalmic solution)
0.02%/0.005% into the United States glaucoma market.
Rocklatan® is now with national and regional U.S. pharmaceutical
wholesalers, and patients can fill prescriptions for Rocklatan®
through their local pharmacies across the nation.
Rocklatan® has already gained non-preferred brand coverage with
payors representing 60% of commercial lives. Additionally,
effective May 1, Medicare Part D preferred tier coverage for
Rhopressa® (netarsudil ophthalmic solution) 0.02% increased
from approximately 40% to 75%. Commercial coverage for Rhopressa®
remains at 90% of lives, with 55% of lives in a preferred tier.
“We are very pleased to announce the availability of
Rocklatan® in the United States. As the first fixed-dose
combination glaucoma medication including a prostaglandin analog
introduced in this country, and the first to contain a Rho kinase
(ROCK) inhibitor in the world, Rocklatan® adds an important
new tool to the treatment paradigm – and a second way to provide
the benefits of a ROCK inhibitor – for physicians and their
patients with glaucoma or ocular hypertension,” said Vicente Anido,
Jr., Ph.D., Chairman and Chief Executive Officer. “In fact,
the approval of Rocklatan® in mid-March was greeted very
enthusiastically by the glaucoma treatment community. These eye
care professionals are now able to prescribe Rocklatan® and
obtain samples of the product.”
Dr. Anido added, “We are also providing a single savings card to
reduce out-of-pocket costs for commercially-insured patients who
are prescribed either Rocklatan® or Rhopressa®. We are
committed to maximum access for patients and we continue to meet
with commercial and Medicare Part D plans to accelerate market
access for Rocklatan® on those formularies. Ultimately, we
believe Rocklatan® has the potential to become a new
cornerstone of medical therapy for glaucoma and ocular
hypertension. At this point, Rhopressa® is covered in a
preferred tier for the majority of commercial and Medicare Part D
lives in the United States. We are delighted to have obtained this
level of market access within one year of the Rhopressa® launch and
believe the increased Medicare Part D coverage to 75% of lives will
bolster volume growth going forward, and Rocklatan® coverage is
already off to a strong start.”
About Rocklatan®
Rocklatan® (netarsudil and latanoprost ophthalmic solution)
0.02%/0.005% 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 intraocular pressure (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. 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.
Rocklatan® was approved by the FDA in March 2019. 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,
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 intraocular pressure
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 is now available
in the United States. 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 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 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/20190501005199/en/
Media: Tad Heitmann
949-526-8747; theitmann@aeriepharma.comInvestors: Ami Bavishi
908-947-3949; abavishi@aeriepharma.com
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