Netarsudil Ophthalmic Solution 0.02% Once Daily
Demonstrated Superiority to Ripasudil 0.4% Twice Daily
Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), an ophthalmic
pharmaceutical company, today reported positive topline results for
the Company’s Phase 3 clinical trial in Japan evaluating netarsudil
ophthalmic solution 0.02% (“netarsudil 0.02%”) versus ripasudil
hydrochloride hydrate ophthalmic solution 0.4% (“ripasudil 0.4%”).
The results showed that netarsudil 0.02% once daily was superior to
ripasudil 0.4% twice daily in lowering intraocular pressure (“IOP”)
at week four (p<0.0001), the primary endpoint for the study.
Both netarsudil 0.02% and ripasudil 0.4% are Rho kinase (ROCK)
inhibitors. They are designed to treat open-angle glaucoma and
elevated IOP by increasing outflow of aqueous humor through the
trabecular outflow pathway, the drainage pathway responsible for
maintaining normal IOP in the eye.
The clinical trial was a single-masked comparison of netarsudil
0.02% dosed once daily versus ripasudil 0.4% dosed twice daily in
245 subjects for four weeks. The baseline mean diurnal IOP was 20.5
and 20.8 millimeters of mercury (“mmHg”) in the netarsudil 0.02%
and ripasudil 0.4% arm, respectively. At four weeks, netarsudil
0.02% reduced mean diurnal IOP by 4.7 mmHg (22.6%) from baseline
compared to 3.0 mmHg (14.3%) with ripasudil 0.4% (p<0.0001).
Netarsudil 0.02% is known by the name Rhopressa® in the United
States and is approved for the reduction of elevated IOP in
patients with open-angle glaucoma or ocular hypertension.
Netarsudil 0.02% is known by the name Rhokiinsa® in the European
Union, where it is approved for the reduction of elevated IOP in
adult patients with primary open-angle glaucoma or ocular
hypertension.
“We are pleased to have successfully completed our first Phase 3
clinical trial in Japan which further confirmed that netarsudil
ophthalmic solution 0.02% achieves impressive IOP-lowering efficacy
in a patient population with lower baseline pressures. We believe
that the statistically superior IOP-lowering of netarsudil versus
the comparator in our study may suggest a very bright future for
our product in Japan, a market where the comparator product is the
only rho-kinase inhibitor commercially available. The IOP-lowering
with netarsudil was consistent with that seen in the previous Phase
2 study conducted in Japan as well as in our ROCKET and MERCURY
studies conducted in the United States for Rhopressa® and
Rocklatan®, respectively. With its once-daily dosing and strong
safety profile, we believe that netarsudil will fulfill an unmet
need for these patients with lower baseline IOPs,” said Benjamin F.
McGraw, III, Pharm.D., Interim Executive Chairman at Aerie.
“The findings also suggest that the IOP reduction may predict
strong efficacy in normal or low-tension glaucoma patients,” said
David A. Hollander, M.D., MBA, Chief R&D Officer at Aerie.
“These patients suffer damage to the optic nerve in spite of having
IOPs in the normal range. Historically it has been challenging to
achieve the IOP reductions needed to prevent vision loss in this
patient population.”
Netarsudil Ophthalmic Solution Phase 3 Clinical Trial
Highlights
- This randomized, multi-center, parallel-group Phase 3 clinical
trial was initiated in November 2020. The objective of the study
was to evaluate the ocular hypotensive efficacy and safety of
netarsudil 0.02% once daily compared to ripasudil 0.4% twice daily,
over a four-week period in patients with open angle glaucoma or
ocular hypertension.
- The study was designed in accordance with the requirements of
Japan’s Pharmaceuticals and Medical Devices Agency (“PMDA”) to
support the potential regulatory submission of netarsudil
ophthalmic solution in Japan. The primary efficacy endpoint was
mean diurnal IOP at four weeks.
- A total of 245 randomized subjects were included, with 122
subjects in the netarsudil 0.02% arm and 123 subjects in the
ripasudil 0.4% arm. A total of 238 patients (97%) completed the
study.
- The baseline mean diurnal IOP was 20.5 and 20.8 mmHg in the
netarsudil 0.02% and ripasudil 0.4% arm, respectively.
- At week four (primary endpoint), the mean diurnal IOP was
statistically significantly lower (16.0 mmHg) in the netarsudil
0.02% group compared to the ripasudil 0.4% group (17.7 mmHg,
p<0.0001).
- Netarsudil 0.02% reduced mean diurnal IOP by 4.7 mmHg (22.6%)
from baseline compared to 3.0 mmHg (14.3%) with ripasudil 0.4%
(p<0.0001). Statistically significant IOP lowering with
netarsudil was also observed at each of the study timepoints, 9 am,
11 am, and 4 pm at all study visits at weeks one, two and four
(p<0.01).
- The medications were safe and well-tolerated. The most common
treatment emergent adverse event was conjunctival hyperemia (54.9%
of subjects with netarsudil 0.02% and 62.6% of subjects with
ripasudil 0.4%). The majority of ocular adverse events were rated
as mild.
Aerie and Santen Pharmaceutical Co., Ltd. (“Santen”) announced
an exclusive collaboration and license agreement for Rhopressa® and
Rocklatan® (netarsudil and latanoprost ophthalmic solution
0.02%/0.0005%) in Japan and several other Asian countries in
October 2020. As part of this agreement, Santen is responsible for
all regulatory process and commercialization related to the
products in the territories covered by the agreement; however,
Aerie and Santen collaborated on this first Phase 3 clinical trial
for Rhopressa® in Japan, which they co-funded.
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 the treatment of dry eye disease,
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 product candidates, preclinical
implants or other future product candidates, including the success
of any partnerships or collaborations entered in connection
therewith, and 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 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 product candidates, preclinical implants or
future product candidates, including statements regarding the
timing of initiation and completion of the studies and trials; our
expectations regarding the effectiveness of Rhopressa®, Rocklatan®,
Rhokiinsa®, Roclanda® or any product candidates, preclinical
implants or other 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 product candidates,
preclinical implants or future product candidates; the potential
advantages of Rhopressa® and Rocklatan® or any product candidates,
preclinical implants or future product candidates; our plans to
pursue development of additional product candidates and
technologies; 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 or to develop new
intellectual property; and our expectations regarding strategic
operations, including our ability to in-license or acquire
additional ophthalmic products, product candidates or technologies.
In particular, FDA and European Medicines Agency (EMA) approval of
Rhopressa® and Rocklatan® do not constitute regulatory approval of
Rhopressa® and Rocklatan® in other jurisdictions, and there can be
no assurance that we will receive regulatory approval for
Rhopressa® and Rocklatan® in such other jurisdictions, including
Japan’s PMDA. In addition, FDA approval of Rhopressa® and
Rocklatan® do not constitute FDA approval of our product
candidates, preclinical implants or any future product candidates,
and there can be no assurance that we will receive FDA approval for
our product candidates, preclinical implants or any future product
candidates. 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/20211012005106/en/
Ami Bavishi (908) 947-3949; abavishi@aeriepharma.com
Aerie Pharmaceuticals (NASDAQ:AERI)
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