Aerie Pharmaceuticals Completes Enrollment of the Netarsudil Ophthalmic Solution Phase 2 Clinical Trial in Japan Months Ahead...
July 09 2019 - 6:30AM
Business Wire
Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) (Aerie), 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 enrollment for its Phase
2 clinical trial of netarsudil ophthalmic solution in Japan is
complete, a milestone reached several months earlier than
previously anticipated.
The first patients to enter this prospective, double-masked,
multi-center, placebo-controlled, parallel group Phase 2 study were
dosed in late March 2019. In approximately 3 months, a total of 215
patients were successfully randomized across four treatment arms:
netarsudil ophthalmic solution 0.01%, netarsudil ophthalmic
solution 0.02%, netarsudil ophthalmic solution 0.04%, and placebo,
all administered once daily in the evening. Netarsudil ophthalmic
solution 0.02% is known by the name Rhopressa® in the United States
where it is approved for the reduction of elevated intraocular
pressure (IOP) in patients with open-angle glaucoma or ocular
hypertension.
“We believe this rapid enrollment reflects the enthusiasm of the
clinical investigators at the 25 centers across Japan that
participated in the study and is a credit to our clinical
operations teams in Tokyo and the United States,” said Vicente
Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie.
“We expect to have topline data from this study in fourth-quarter
2019, allowing us to confirm the concentration of netarsudil we
will take forward into Phase 3 trials in Japan.”
The study was designed in accordance with the requirements of
Japan’s PMDA (Pharmaceuticals and Medical Devices Agency) as a
precursor to Phase 3 trials supporting potential regulatory
submission of netarsudil ophthalmic solution in Japan. The
objective of the study is to evaluate the IOP-reducing effect and
safety of the three concentrations of netarsudil ophthalmic
solution over a 28-day period. Entry criteria include unmedicated
baseline IOP ranges at 9:00 AM of 15 mmHg (millimeters of mercury)
to less than 35 mmHg for patients with open-angle glaucoma, and 22
mmHg to less than 35 mmHg for patients with ocular hypertension.
Studies of glaucoma in Japan suggest that patients have baseline
IOP that is generally lower than patients in other populations,
hence the baseline IOP range in this study begins at 15 mmHg, lower
than is typical of glaucoma studies in the United States or
Europe.
As agreed with the PMDA, the design of this trial is consistent
with that of a recent Phase 2 pilot study that Aerie conducted in a
Japanese-American population in the United States, with the
addition of the netarsudil ophthalmic solution 0.01% treatment arm
to confirm the concentration of netarsudil most suitable for
Japanese patients. Topline results of the pilot study showed that
netarsudil ophthalmic solution 0.02% reduced mean diurnal IOP by a
range of 5.0 to 5.3 mmHg in patients with an average baseline IOP
of 18.3 mmHg and netarsudil ophthalmic solution 0.04% reduced mean
diurnal IOP by a range of 5.2 to 6.6 mmHg in patients with average
baseline IOP of 20.2 mmHg. Both netarsudil arms produced
significantly greater IOP reduction than placebo at Day 28. The
safety findings were consistent with previous netarsudil
trials.
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 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, has been approved by the FDA and was launched in the
United States in the second quarter of 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 include statements regarding our
intentions, beliefs, projections, outlook, analyses or current
expectations. In this release those include discussion of our
expectations regarding the success, timing and cost of our ongoing
and anticipated preclinical studies and clinical trials in Japan,
and the expected timing of, and timing of regulatory and/or other
review of, filings for, as applicable, netarsudil ophthalmic
solution and any future product candidates and technologies within
and beyond ophthalmology. 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 any future product candidates. 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/20190709005117/en/
Media: Tad Heitmann 949-526-8747; theitmann@aeriepharma.com
Investors: Ami Bavishi 908-947-3949; abavishi@aeriepharma.com
Aerie Pharmaceuticals (NASDAQ:AERI)
Historical Stock Chart
From Aug 2024 to Sep 2024
Aerie Pharmaceuticals (NASDAQ:AERI)
Historical Stock Chart
From Sep 2023 to Sep 2024