Aerie Pharmaceuticals Reports Positive RhopressaTM QD (netarsudil ophthalmic solution) 0.02% 12 Month Interim Safety Results for Rocket 2
RhopressaTM QD Maintained Consistent
IOP-Lowering Efficacy through 12 Months
Conference Call and Webcast with Accompanying Slides Today, February
17, 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 glaucoma therapies, today reported
the successful 12-month interim safety results of Rocket 2, Aerie's
second Phase 3 registration trial for RhopressaTM (netarsudil
ophthalmic solution) 0.02%, a novel once-daily eye drop being tested for
its ability to lower intraocular pressure (IOP) in patients with
glaucoma or ocular hypertension. The Company previously reported that
Rocket 2 had achieved its primary 90-day efficacy endpoint of
demonstrating non-inferiority of IOP lowering for RhopressaTM
QD compared to timolol BID. The Rocket 2 trial is a pivotal trial
expected to be part of Aerie's NDA filing for RhopressaTM,
which we expect to submit to the FDA in the third quarter of 2016.
Management will host a conference call and provide accompanying slides
to discuss these results at 5:00 p.m. ET today.
RhopressaTM QD Safety and Efficacy
Highlights for Rocket 2
The first 118 patients on RhopressaTM QD for the 12-month
period demonstrated safety results consistent with those observed for
the 90 day efficacy period. There were no new adverse events that
developed over the 12-month period, and there were no drug-related
serious adverse events.
As expected, the most common adverse event was conjunctival hyperemia,
or eye redness. Increased hyperemia over baseline was observed by
biomicroscopy at a rate of 30 percent, of which 76 percent was
considered mild. Hyperemia was sporadic; 70 percent of patients with
prior conjunctival hyperemia had no hyperemia at month 12.
The other adverse events observed during the twelve-month trial are
consistent with those observed during the initial 90-day efficacy
period. They included conjunctival hemorrhages, corneal deposits, and
blurry vision, ranging from 5 percent to 23 percent of the 118
Rocket 2 included IOP measurements at 8 am only at months six, nine
and 12, in addition to the diurnal measurements taken during the
initial 90-day efficacy period. For the first 118 patients who reached
the 12-month mark, RhopressaTM QD demonstrated a consistent
level of IOP lowering at 8 am from day 90 through month 12, with a
nominal variance of only 0.1 mmHg between day 90 and month 12.
"We are very pleased to see that RhopressaTM QD continues to
demonstrate a positive safety profile and, very importantly, consistent
IOP lowering throughout the 12-month period. Our NDA filing remains on
track for the third quarter of 2016," said Vicente Anido, Jr., Ph.D.,
Chief Executive Officer and Chairman at Aerie.
Dr. Anido continued, "In addition to proceeding with our RhopressaTM
NDA filing, we also look forward to our first Phase 3 90-day efficacy
readout for RoclatanTM, also expected in the third quarter of
2016. On a separate note, we are reporting that our preliminary cash
burn for full-year 2015 is consistent with our earlier guidance of
approximately $60 million, and our year-end 2015 cash, marketable
securities and investments amounted to approximately $150 million. We
remain well-financed for 2016."
Richard A. Lewis, M.D., Aerie's Chief Medical Officer, and glaucoma
specialist, stated, "We expect that clinicians will be highly satisfied
with the long-term safety and efficacy results demonstrated in our
clinical trials. They have waited for a generation for a product with
the novel qualities of RhopressaTM."
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 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
RhopressaTM also lowers episcleral venous pressure, which
contributes approximately half of IOP in healthy subjects. Further,
RhopressaTM provides an additional mechanism that reduces
fluid production in the eye and therefore lowers IOP. Biochemically,
RhopressaTM is known to inhibit both Rho Kinase (ROCK) and
norepinephrine transporter (NET). Recent preclinical studies have shown
that RhopressaTM 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 RhopressaTM. The representations
above regarding the RhopressaTM mechanisms of action are the
result of Aerie's preclinical studies and clinical trials.
There are two Phase 3 registration trials (Rocket 2 and Rocket 1) for
RhopressaTM required for NDA filing. Rocket 2 will be the
pivotal trial and Rocket 1 will be supportive for the NDA filing that we
expect to submit to the FDA in the third quarter of 2016. Rocket 2, the
interim safety results of which are reported in this press release, is a
12-month trial which previously achieved its 90-day primary efficacy
endpoint. For Rocket 2, the 90-day efficacy period included IOP
measurements at week two, week six and day 90 at 8 am, 10 am and 4 pm.
Thereafter, safety observations and IOP measurements were conducted at 8
am only at the end of months six, nine and twelve. 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 but not needed for NDA
filing. A fourth Phase 3 trial, Rocket 4, commenced in late September
2015, and is designed to provide adequate six-month safety data to meet
regulatory filing requirements in Europe, and is also not required for
the NDA filing in the U.S.
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
twelve-month safety 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 Rocket 2 safety study will be
discussed on the conference call and are posted to Aerie's website.
Please connect to Aerie'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 54571139.
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 54571139.
The telephone replay will be available until February 24, 2016.
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 IOP-lowering
therapies with novel mechanisms of action to treat patients with
glaucoma and ocular hypertension. It is expected that the NDA filing for
RhopressaTM (netarsudil ophthalmic solution) 0.02% will take
place in the third quarter of 2016. The 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 one Phase 3
registration trial underway, named Mercury 1, with a second trial
expected to commence in March 2016. If these trials are successful, a
RoclatanTM NDA filing is expected to take place in the second
half of 2017. Aerie also announced in 2015 its research collaborations
with GrayBug, Inc. and Ramot at Tel Aviv University as it further builds
its pipeline for future growth.
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 the issuance and sale of shares of our common stock in
connection with our "at the market" sales agreements; 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; and our expectations regarding strategic
operations, including our ability to in-license or acquire additional
ophthalmic products or product candidates. 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. In addition, the financial information presented above is
preliminary, based solely on information available to us as of the date
of this press release, and may differ materially from final 2015
financial results. 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: http://www.businesswire.com/news/home/20160217006453/en/
Richard Rubino, 908-947-3540
McClellan, Inc., on behalf of Aerie Pharmaceuticals
Source: Aerie Pharmaceuticals, Inc.
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