- Roclanda® Achieves Non-Inferiority to
Ganfort® - - Mercury 3 Performance Exceeds Prior Phase 3 Trials
-
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, ocular surface diseases and
retinal diseases, today announced successful interim 90-day topline
data from its six-month Phase 3b clinical trial in Europe known as
Mercury 3, comparing Roclanda® to Ganfort®.
Roclanda® is marketed in the United States as Rocklatan®
(netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%.
Ganfort® is approved for use in Europe but is not approved for use
in the United States.
Mercury 3 was designed as a non-inferiority trial to compare
intraocular pressure (IOP) reduction in patients with open-angle
glaucoma or ocular hypertension.
Interim 90-Day Topline
Highlights:
- Roclanda® met the overall trial objective by demonstrating
non-inferiority to Ganfort® across nine of nine timepoints over 90
days.
- Roclanda® demonstrated consistent IOP reduction throughout the
day of approximately 9.5 millimeters of mercury (mmHg) for an
average reduction from baseline IOPs of approximately 37
percent.
- The IOP reductions observed in Mercury 3 exceeded those from
both Mercury 1 and Mercury 2.
- The IOP reduction results for Roclanda® were highly consistent
with those of Ganfort®.
- Incidence of ocular adverse events for Roclanda® were lower
than observed in Mercury 1 and Mercury 2.
- Six-month topline results are expected by early 2021.
“We are pleased to have another set of clinical trial data that
yet again reinforces the excellent efficacy profile of Rocklatan®.
As background, Mercury 3 is not necessary for regulatory approval
in Europe but rather is intended to elucidate its pricing and
commercialization prospects in that region,” said Vicente Anido
Jr., Ph.D., Chairman and Chief Executive Officer at Aerie.
Dr. Anido continued, “We believe these interim topline results
point to consistent pricing levels for the two comparators in the
trial. While we expect to receive approval for Roclanda® by early
next year, we will wait for further clarity on U.S. pricing
ramifications before determining the nature and timing of launch
plans in Europe.”
About the Mercury 3 Clinical Trial and Comparators
Mercury 3 was designed as a non-inferiority trial to compare
intraocular pressure (IOP) reduction in patients with open angle
glaucoma or ocular hypertension. Approximately 430 subjects
satisfying inclusion criteria were randomized to one of two arms
and received masked study medication once-daily in the evening.
The Mercury 3 clinical trial included Roclanda®, which in the
United States is marketed as Rocklatan® (netarsudil and latanoprost
ophthalmic solution) 0.02%/0.005% and represents a fixed-dose
combination of Rhopressa® (netarsudil ophthalmic solution) 0.02%
and prostaglandin analog latanoprost. Ganfort® represented the
comparator, a fixed-dose combination of prostaglandin analog
Lumigan® and beta blocker timolol.
Rocklatan® is the only fixed-dose combination product
commercially available in the United States that includes a
prostaglandin analog. The Ganfort® fixed-dose combination includes
a prostaglandin analog and a beta blocker, and while it is approved
for use in Europe, it is not approved for use in the United
States.
About Rocklatan® (named Roclanda® in Europe)
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.
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,
ocular surface diseases and retinal diseases. 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 IOP 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, was launched in the United States in May 2019. 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 in this release include statements
regarding our intentions, beliefs, projections, outlook, analyses
or current expectations concerning, among other things: the
duration and severity of the coronavirus disease (COVID-19)
outbreak, including the impact on our clinical and commercial
operations, demand for our products and financial results and
condition of our global supply chains; our expectations regarding
the commercialization and manufacturing of Rhopressa®, Rocklatan®,
Rhokiinsa® and Roclanda® or any current or future product
candidates, including the timing, cost or other aspects of their
commercial launch; our commercialization, marketing, manufacturing
and supply management capabilities and strategies in and outside of
the United States; the success, timing, pricing 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, and any current or future product
candidates, including statements regarding the timing of initiation
and completion of the studies and trials, such as statements in
this press release regarding our expectations regarding the
effectiveness of Rhopressa®, Rocklatan®, Rhokiinsa®, Roclanda® or
any current or future product candidates; 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 current or 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 current or future product candidates;
the potential advantages of Rhopressa® and Rocklatan® or any
current or future product candidates; our plans to pursue
development of additional product candidates and technologies; 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. In particular, the topline data presented herein is
preliminary and based solely on information available to us as of
the date of this press release and additional information about the
results may be disclosed at any time. Additionally, FDA approval of
Rhopressa® and Rocklatan® and EMA approval of Rhokiinsa® do not
constitute regulatory approval of Rhopressa® and Rocklatan® in
other jurisdictions, including EMA approval of Roclanda®, and there
can be no assurance that we will receive regulatory approval for
Rhopressa® and Rocklatan® in such other jurisdictions, including
EMA approval of Roclanda®. In addition, FDA approval of Rhopressa®
and Rocklatan® do not constitute FDA approval of our current or any
future product candidates, and there can be no assurance that we
will receive FDA approval for our current or any future product
candidates. Furthermore, EMA acceptance of the MAA for Roclanda®
does not constitute EMA approval of Roclanda®, and there can be no
assurance that we will receive EMA approval of Roclanda®. 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). 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200924005095/en/
Media: Tad Heitmann 949-526-8747; theitmann@aeriepharma.com
Investors: Ami Bavishi 908-947-3949; abavishi@aeriepharma.com
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