Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage
pharmaceutical company focused on the discovery, development and
commercialization of first-in-class glaucoma therapies, today reported
the successful results of its second Phase 3 trial for Rhopressa™,
a novel once-daily, triple-action eye drop being tested for its ability
to lower intraocular pressure (IOP) in patients with glaucoma or ocular
hypertension. The trial achieved its primary efficacy endpoint
demonstrating non-inferiority of Rhopressa™ compared to
timolol, the most widely used comparator. Management will host a
conference call and provide accompanying slides to discuss these results
at 5:00 p.m. ET today.
Rhopressa™ Phase 3 Highlights for Rocket 2
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Rhopressa™, dosed both once-daily and twice-daily, achieved
its primary efficacy endpoint demonstrating non-inferiority compared
to twice-daily timolol. The primary efficacy endpoint evaluated
subjects with pre-study baseline IOPs of above 20 to below 25 mmHg
(millimeters of mercury).
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The Rocket 2 efficacy results for Rhopressa™ demonstrated a
consistent level of IOP lowering across all baseline IOPs and
throughout the 90-day efficacy period.
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The most common Rhopressa™ adverse event was hyperemia, or
eye redness, which was reported as increased in 35 percent of patients
and was scored as mild for 83 percent of patients in the Rhopressa™
once-daily arm of the trial. The adverse event profile for the
Rhopressa™ once-daily arm was consistent with the results
of Rocket 1.
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With these successful Rocket 2 results, and the successful performance
of Rhopressa™ in Rocket 1 at baseline IOPs below 25 mmHg,
Aerie expects to file its NDA for Rhopressa™ in mid-2016.
As expected, Rhopressa™ dosed twice-daily generated a higher
incidence of adverse events and was slightly more efficacious than
Rhopressa™ dosed once-daily.
“We are very impressed by these Rhopressa™ Phase 3 results
from the Rocket 2 study. This product has demonstrated great promise
with its novel mechanisms of action, including its ability to target the
diseased tissue responsible for elevated IOP in glaucoma. The clear
success demonstrated in this clinical trial, combined with the
preclinical research to date on the disease-modification potential of
Rhopressa™, represent key building blocks in driving Aerie
toward becoming a major ophthalmic pharmaceutical company,” said Vicente
Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie.
Dr. Anido continued, “We look forward to our Rocket 2 safety results
expected at the end of 2015 or early 2016. Based on our previous
discussions with the FDA, we expect to file our Rhopressa™
NDA in mid-2016.”
Richard A. Lewis, M.D., Aerie’s newly appointed Chief Medical Officer
who is a glaucoma specialist in Sacramento, California, past President
of the American Society of Cataract and Refractive Surgeons (ASCRS) and
past President of the American Glaucoma Society (AGS), added,
“Clinicians have been waiting for an IOP-lowering product that targets
the diseased tissue. None of the treatments currently in the market have
this unique function. The Rhopressa™ efficacy data we see in
these Rocket 2 results point to a potential breakthrough for our
glaucoma patients.”
Triple-Action Rhopressa™
Rhopressa™ is a novel triple-action eye drop that we believe,
if approved, would become the only once-daily product available that
specifically targets the trabecular meshwork, the eye’s primary fluid
drain and the diseased tissue responsible for elevated IOP in glaucoma.
Preclinical results have demonstrated that Rhopressa™ also
lowers episcleral venous pressure, which contributes approximately half
of IOP in healthy subjects. Further, Rhopressa™ provides an
additional mechanism that reduces fluid production in the eye and
therefore lowers IOP. Biochemically, Rhopressa™ is known to
inhibit both Rho Kinase (ROCK) and norepinephrine transporter (NET).
Recent preclinical studies have shown that Rhopressa™ may
have disease-modifying properties, including an anti-fibrotic effect on
the trabecular meshwork and the potential to increase perfusion of the
trabecular meshwork. Preclinical research is also currently underway to
evaluate the potential neuroprotective benefits of Rhopressa™.
There are four Phase 3 registration trials for Rhopressa™.
“Rocket 2,” the efficacy results of which are reported in this press
release, is a 12-month safety trial with a 90-day interim efficacy
readout. Safety data for the 12-month period of the Rocket 2 trial is
expected late 2015 or early 2016. “Rocket 1,” the results of which were
initially reported in April 2015, was a 90-day efficacy trial that did
not achieve its primary endpoint, but did achieve its pre-specified
secondary endpoint. “Rocket 3” is a 12-month safety-only study in Canada
which is currently in progress. A fourth Phase 3 trial, named “Rocket
4,” is expected to commence in late September 2015. Based on the
successful results of Rocket 2, Aerie expects to submit a New Drug
Application filing for Rhopressa™ in mid-2016.
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 Rhopressa™ Phase 3
efficacy results from Rocket 2.
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 Rhopressa™ Rocket 2
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 42505859. 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 42505859. The telephone replay will be available until September 22,
2015.
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 reported today the successful results of the Phase 3
registration trial in the United States named Rocket 2, where the
primary efficacy endpoint was to demonstrate non-inferiority of IOP
lowering for Rhopressa™ compared to timolol. Aerie recently
completed its first Phase 3 registration trial, named Rocket 1, the
three-month efficacy results of which were initially reported in April
2015, and expects to commence a fourth Phase 3 registration trial, named
Rocket 4, in late September 2015. Aerie also completed in 2014 a Phase
2b clinical trial in which Roclatan™ met the primary efficacy
endpoint, demonstrating the statistical superiority of Roclatan™
to each of its components, and plans to commence the first Phase 3
registration trial for Roclatan™, named Mercury 1, in late
September 2015. Aerie also recently announced research collaborations
with GrayBug, Inc. and Ramot at Tel Aviv University as it further builds
it pipeline for future growth.
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: 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; 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 press release.

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