Conference Call and Webcast Today, April 12, at 5:00 p.m. ET
IRVINE, Calif.--(BUSINESS WIRE)--
Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage
pharmaceutical company focused on the discovery, development and
commercialization of first-in-class therapies for the treatment of
glaucoma and other diseases of the eye, today reported the successful
six-month topline safety and efficacy results of its Rocket 4 Phase 3
clinical trial for product candidate RhopressaTM, a novel
once-daily eye drop being tested for its ability to lower intraocular
pressure (IOP) in patients with glaucoma or ocular hypertension. The
Rocket 4 trial was designed to provide six-month safety data adequate
for European regulatory filing purposes. Rocket 4 was not necessary for
U.S. NDA (New Drug Application) filing purposes, although data from the
90-day efficacy component of the trial was included in the February 2017
RhopressaTM NDA submission as supportive.
Rocket 4 enrollment totaled approximately 700 patients and was a two-arm
six-month trial, which included a 90-day efficacy readout evaluating
once-daily RhopressaTM for non-inferiority to twice-daily
timolol. The 90-day efficacy readout, which took place in October 2016,
demonstrated successful achievement of the 90-day primary efficacy
endpoint. This final readout from Rocket 4 includes six-month safety
data and diurnal efficacy measurements at months four, five and six,
which do not constitute a primary efficacy endpoint.
Management will host a conference call and provide accompanying slides
to discuss these results at 5:00 p.m. ET today.
RhopressaTM Phase 3 Six-Month Topline
Highlights for Rocket 4
The objective of the RhopressaTM Rocket 4 clinical trial is
to provide six-month safety data adequate for regulatory filing in
Europe and is not required for U.S. FDA approval. The European
regulatory filing for RhopressaTM is currently expected to
take place in the second half of 2018.
Safety data observed over the six months were consistent with
observations in previous RhopressaTM three-month and
twelve-month Phase 3 clinical trials.
The most common RhopressaTM adverse event was hyperemia, or
eye redness, which was reported in approximately 48 percent of
patients, 75 percent of which was mild. Other adverse events, which
have also been observed in previous RhopressaTM clinical
trials, were reported in 5 percent to 25 percent of patients,
consistent with the 12-month safety data from Rocket 2. There were no
drug-related systemic or serious adverse events.
RhopressaTM performance at months four, five and six
remained within the non-inferiority range compared to timolol at each
of the intraocular pressure (IOP) measurement time points, including 8
a.m., 10 a.m., and 4 p.m. at baseline IOPs ranging from above 20 mmHg
(millimeters of mercury) to below 25 mmHg, and also from above 20 mmHg
to below 27 mmHg.
The Rocket 4 six-month efficacy results for RhopressaTM
demonstrated a consistent level of IOP lowering across all baseline
IOPs in the trial, and consistent IOP lowering throughout the
"These successful six-month Rocket 4 safety and efficacy results
reconfirm, as observed in our previous clinical trials, that RhopressaTM
is an efficacious and well-tolerated drug. Rocket 4 represents the final
Phase 3 clinical trial for RhopressaTM, and we now possess
clinical data on RhopressaTM for well over 2,000 patients,"
said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at
Dr. Anido continued, "We look forward to our upcoming 90-day efficacy
readout later this quarter from Mercury 2, the second Phase 3
registration trial for RoclatanTM (netarsudil/latanoprost
ophthalmic solution) 0.02%/0.005%. Mercury 2 is structured consistently
with Mercury 1, but is of 90-day duration. The 12-month safety data from
Mercury 1 are expected in the third quarter of this year."
RhopressaTM (netarsudil ophthalmic solution) 0.02%, is a
novel eye drop that we believe, if approved, would become the only
once-daily product available that, based on Aerie's preclinical and
clinical studies, specifically targets the trabecular meshwork, the
eye's primary fluid drain and the diseased tissue responsible for
elevated intraocular pressure (IOP) in glaucoma. Preclinical and
clinical studies have also demonstrated that RhopressaTM
lowers episcleral venous pressure, which contributes approximately half
of IOP in healthy subjects. Further, based on Aerie's preclinical
studies, RhopressaTM may provide an additional mechanism that
reduces fluid production in the eye and therefore lowers IOP.
Biochemically, the active ingredient in RhopressaTM,
netarsudil, has been shown in Aerie studies to inhibit both Rho Kinase
(ROCK) and norepinephrine transporter (NET). Recent preclinical studies
have also shown that RhopressaTM may have disease-modifying
properties, including an anti-fibrotic effect of netarsudil on
trabecular meshwork cells and the potential to increase perfusion of the
The results of two Phase 3 registration trials (Rocket 2 and Rocket 1)
for RhopressaTM were included in the NDA submission to the
FDA in February 2017. Rocket 2 represents the pivotal trial, and Rocket
1 is supportive. There were two recently completed additional Phase 3
registration trials for RhopressaTM, named Rocket 3 and
Rocket 4. Rocket 3 was a small 12-month safety-only study in Canada that
is now completed but was not necessary for the NDA submission. Rocket 4
was designed to provide adequate six-month safety data for regulatory
filing purposes in Europe, and was also not needed for the NDA
submission. The 90-day efficacy results from Rocket 4 and Mercury 1, the
initial Phase 3 registration trial for Aerie product candidate RoclatanTM
(netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, were also
included in the RhopressaTM NDA submission as supportive.
Conference Call / Web Cast Information
Aerie management will host a live conference call and webcast at 5:00
p.m. Eastern Time today to discuss the RhopressaTM Phase 3
six-month clinical trial results from Rocket 4.
The live webcast and a replay may be accessed by visiting Aerie's
website at http://investors.aeriepharma.com.
In addition, key data slides from the RhopressaTM Rocket 4
study will be discussed on the conference call and are posted to the
website. Please connect to the Company's website at least 15 minutes
prior to the live webcast to ensure adequate time for any software
download that may be needed to access the webcast. Alternatively, please
call 1-888-734-0328 (U.S.) or 1-678-894-3054 (international) to listen
to the live conference call. The conference ID number for the live call
is 4540190. Please dial in approximately 10 minutes prior to the call.
Telephone replay will be available approximately two hours after the
call. To access the replay, please call 1-855-859-2056 (U.S.) or
1-404-537-3406 (international). The conference ID number for the replay
is 4540190. The telephone replay will be available until April 19, 2017.
About Aerie Pharmaceuticals, Inc.
Aerie is a clinical-stage pharmaceutical company focused on the
discovery, development and commercialization of first-in-class therapies
for the treatment of patients with glaucoma and other diseases of the
eye. Aerie's two lead product candidates are once-daiIy intraocular
pressure-lowering therapies with novel mechanisms of action to treat
patients with glaucoma or ocular hypertension. The NDA for RhopressaTM
(netarsudil ophthalmic solution) 0.02% was submitted to the FDA in
February 2017. Aerie's second product candidate, RoclatanTM
(netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, which is a
fixed dose combination of RhopressaTM and widely prescribed
PGA latanoprost, currently has two Phase 3 registration trials underway,
named Mercury 1 and Mercury 2. If these trials are successful, a RoclatanTM
NDA submission is expected to take place in late 2017 or early 2018.
Aerie is also focused on the development of additional product
candidates and technologies in ophthalmology.
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: the
success, timing and cost of our ongoing and anticipated preclinical
studies and clinical trials for our current product candidates,
including statements regarding the timing of initiation and completion
of the studies and trials; our expectations regarding the clinical
effectiveness of our product candidates and results of our clinical
trials; the timing of and our ability to obtain and maintain U.S. Food
and Drug Administration or other regulatory authority approval of, or
other action with respect to, our product candidates; our expectations
regarding the commercialization of our product candidates; our
expectations related to the use of proceeds from our initial public
offering and the issuance and sale of our senior secured convertible
notes and additional subsequent financings; our estimates regarding
anticipated capital requirements and our needs for additional financing;
the potential advantages of our product candidates; our plans to pursue
development of our product candidates for additional indications and
other therapeutic opportunities; our plans to explore possible uses of
our existing proprietary compounds beyond glaucoma; and our ability to
protect our proprietary technology and enforce our intellectual property
rights. By their nature, forward-looking statements involve risks and
uncertainties because they relate to events, competitive dynamics and
industry change, and depend on regulatory approvals and economic
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, the preclinical research
discussed in this press release is preliminary and the outcome of such
preclinical studies may not be predictive of the outcome of later
clinical trials. Any future clinical trial results may not demonstrate
safety and efficacy sufficient to obtain regulatory approval related to
the preclinical research findings discussed in this press release.
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
View source version on businesswire.com: http://www.businesswire.com/news/home/20170412006000/en/
Richard Rubino, 908-947-3540
McClellan, Inc., on behalf of Aerie Pharmaceuticals
Source: Aerie Pharmaceuticals, Inc.
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