DURHAM, N.C.–(BUSINESS WIRE)–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.
Contacts
Media: Tad Heitmann 949-526-8747; theitmann@aeriepharma.com
Investors:
Ami Bavishi 908-947-3949; abavishi@aeriepharma.com