RoclatanTM Successfully Achieves Primary
Efficacy Endpoint in Mercury 1 Study
Conference Call and Webcast Today, September 14, 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
90-day primary efficacy results of its 12-month Phase 3 "Mercury 1"
clinical trial for its fixed-dose combination product candidate, RoclatanTM.
The study achieved its primary efficacy endpoint demonstrating
statistical superiority over each of its components, including Aerie
product candidate RhopressaTM (netarsudil ophthalmic
solution) 0.02%, and market leading prostaglandin analogue (PGA)
latanoprost, all of which were dosed once daily in the evening. The
study evaluated patients with maximum baseline intraocular pressures
(IOPs) ranging from above 20 to below 36 mmHg (millimeters of mercury).
The IOP-lowering effect of RoclatanTM was 1 to 3 mmHg greater
than monotherapy with either latanoprost or RhopressaTM
throughout the duration of the study. Management will host a conference
call with accompanying slides to discuss these results at 5:00 p.m. ET
today. The accompanying slides are available at Aerie's web site,
RoclatanTM Phase 3 Highlights for Mercury 1
RoclatanTM dosed once daily achieved the primary efficacy
endpoint of demonstrating statistical superiority over both
latanoprost and RhopressaTM at the primary endpoint range
of baseline IOPs from above 20 to below 36 mmHg for each of the nine
measured time points.
IOPs were measured at 8 a.m., 10 a.m., and 4 p.m. at week 2, week 6,
and day 90. RoclatanTM IOP lowering exceeded that of
latanoprost in a range of 1.3 to 2.5 mmHg, and exceeded RhopressaTM
IOP lowering in a range of 1.8 to 3.0 mmHg. Efficacy levels were
consistent across the 90-day period for all arms in the study.
RoclatanTM mean diurnal IOP-lowering exceeded that of
latanoprost by an average across the study duration of 1.9 mmHg and
exceeded RhopressaTM by 2.6 mmHg.
RoclatanTM reduced mean diurnal IOPs to 16 mmHg or lower in
61 percent of patients, a significantly higher percentage than
observed in the comparator arms.
The most common RoclatanTM adverse event was hyperemia, or
eye redness, which was reported in approximately 50 percent of
patients, or 30 percent above baseline, and was scored as mild for the
large majority of these patients. There were no drug-related serious
adverse events for any of the comparators in the trial.
Aerie will hold an "Investor Day" in New York City on October 5, 2016
to cover further details from the Mercury 1 trial and to provide a
general business update.
"We are very pleased by these RoclatanTM 90-day efficacy
results from the Mercury 1 clinical trial. As expected, the topline
efficacy demonstrated in this trial clearly reconfirms the potential for
RoclatanTM to become the most efficacious IOP-lowering
therapy to enter the market, if approved. If Mercury 1 and 2 are
successful, we expect to file the NDA for RoclatanTM near
year-end 2017," said Vicente Anido, Jr., Ph.D., Chairman and Chief
Executive Officer at Aerie.
Dr. Anido continued, "We also noted that the RhopressaTM arm
demonstrated high levels of efficacy across the full range of baseline
IOPs studied, and the efficacy was maintained for the 90-day period.
Importantly, RhopressaTM demonstrated comparable levels of
IOP lowering to latanoprost at baseline IOPs ranging from 20 to 25 mmHg
in Mercury 1. This performance for RhopressaTM is consistent
with levels observed in the previous Phase 2b trials for RhopressaTM
Richard A. Lewis, M.D., Aerie's Chief Medical Officer added, "Once-daily
RoclatanTM has shown a degree of IOP lowering in Mercury 1
that is quite impressive, especially when considering its ability to
bring patient pressures down to levels as low as 8 to 14 mmHg. The
safety profile of RoclatanTM observed thus far in Mercury 1
points to a safe and tolerable product."
RoclatanTM is a once-daily eye drop that combines RhopressaTM,
as described below, with latanoprost, a PGA that is the most widely
prescribed glaucoma drug in the world. Based on our preclinical studies
and clinical trials, we believe that RoclatanTM, if approved,
would be the first glaucoma product to lower IOP through all known
mechanisms: (i) increasing fluid outflow through the trabecular
meshwork, the eye's primary drain, (ii) increasing fluid outflow through
the uveoscleral pathway, the eye's secondary drain, (iii) reducing fluid
production in the eye, and (iv) reducing episcleral venous pressure
(EVP). By covering the full spectrum of known IOP-lowering mechanisms,
RoclatanTM has the potential to provide a greater
IOP-lowering effect than any currently approved glaucoma product.
The first Phase 3 registration trial for RoclatanTM, named
Mercury 1 is a 12-month safety trial in 718 patients with a 90-day
efficacy readout, which is the subject of this press release. The
topline efficacy readout demonstrated that RoclatanTM was
statistically superior to each of its components. The second Phase 3
registration trial, named Mercury 2, is a 90-day efficacy trial that
commenced in March 2016, and a third Phase 3 registration trial, named
Mercury 3, is expected to commence in Europe in the first half of 2017.
Mercury 3 is not necessary for approval in the U.S., but rather to
facilitate regulatory approval and commercialization in Europe.
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 studies,
specifically targets the trabecular meshwork, the eye's primary fluid
drain and the diseased tissue responsible for elevated IOP in glaucoma.
Preclinical 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 provides an additional mechanism that
reduces fluid production in the eye and therefore lowers IOP.
Biochemically, RhopressaTM 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
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 results of two Phase 3 registration trials (Rocket 2 and Rocket 1)
for RhopressaTM were included in a NDA filing submitted to
the FDA in the third quarter of 2016. Rocket 2 represents the pivotal
trial, and Rocket 1 is supportive. There are two additional Phase 3
trials currently underway for RhopressaTM, named Rocket 3 and
Rocket 4. Rocket 3 is a 12-month safety-only study in Canada that is not
needed for the NDA filing. Rocket 4 is designed to provide adequate
six-month safety data for regulatory filing purposes in Europe, and is
also not needed for the NDA filing.
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 RoclatanTM Phase 3
efficacy results from Mercury 1, including a review of the associated
slides that are posted on Aerie's web site, aeriepharma.com.
The live webcast and a replay may be accessed by visiting Aerie's
website at http://investors.aeriepharma.com.
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 (888)
734-0328 (U.S.) or (678) 894-3054 (international) to listen to the live
conference call. The conference ID number for the live call is 81417412.
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 (855) 859-2056 (U.S.) or (404) 537-3406
(international). The conference ID number for the replay is 81417412.
The telephone replay will be available until September 21, 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-daily IOP-lowering
therapies with novel mechanisms of action to treat patients with
glaucoma or ocular hypertension. The NDA filing for RhopressaTM
(netarsudil ophthalmic solution) 0.02% was submitted 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 two Phase 3 registration trials underway,
named Mercury 1 and Mercury 2. If these trials are successful, a RoclatanTM
NDA filing is expected to take place near year-end 2017. 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 request, 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
topline Mercury 1 data presented herein is preliminary and based solely
on information available to us as of the date of this press release and
additional information about the results may be disclosed at any time,
including at our Investor Day on October 5, 2016. In addition, 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160914006223/en/
Richard Rubino, 908-947-3540
McClellan, Inc., on behalf of Aerie Pharmaceuticals
Source: Aerie Pharmaceuticals, Inc.
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