Roclatan™ Successfully Demonstrates a
Positive Safety Profile and Efficacy Levels Consistent with
Previously Reported Results
Conference Call and Webcast Today, July 19,
at 5:00 p.m. ET
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
patients with glaucoma and other diseases of the eye, today
reported the successful 12-month safety results of the Company’s
“Mercury 1” Phase 3 registration trial for its fixed-dose
combination product candidate, Roclatan™. Mercury 1 is a 12-month
safety and efficacy trial which included a 90-day efficacy
endpoint. As previously reported, both Mercury 1 and Mercury 2, the
Company’s second Phase 3 registration trial of Roclatan™, achieved
their 90-day primary efficacy endpoints of demonstrating
statistical superiority over each of its components at all measured
time points, including Aerie product candidate Rhopressa™
(netarsudil ophthalmic solution) 0.02%, and market-leading
prostaglandin analogue (PGA) latanoprost, all of which were dosed
once daily in the evening.
The purpose of the 12-month Mercury 1 study is to provide
adequate safety data for an expected NDA (new drug application)
submission to the FDA in the first half of 2018. While not primary
endpoints, the study also included measurements of intraocular
pressure (IOP) at 8 a.m., 10 a.m. and 4 p.m. at months six, nine
and twelve. The 12-month safety and efficacy results of Mercury 1
were consistent with the 90-day results from the Mercury 1 and
Mercury 2 trials, each of which evaluated patients with maximum
baseline IOPs ranging from above 20 to below 36 mmHg (millimeters
of mercury). Management will host a conference call with
accompanying slides to discuss these results at 5:00 p.m. Eastern
Time (ET) today. The accompanying slides will be available at
Aerie’s website, aeriepharma.com.
Roclatan™ 12-Month Safety and Efficacy Highlights for Mercury
1
- Safety results for Roclatan™ for the
12-month period were consistent with those observed for the 90-day
efficacy period in the trial. There were no new adverse events that
developed following the initial 90-day period, and there were no
drug-related serious or systemic adverse events.
- As expected, the most common adverse
event for Roclatan™ was conjunctival hyperemia, or eye redness,
which was observed in approximately 60 percent of patients, of
which approximately 70 percent was determined to be mild by
biomicroscopy. As observed in previous trials, hyperemia was
sporadic, with only approximately 10 percent of patients with
hyperemia across each physician visit during the 12-month
period.
- The other Roclatan™ adverse events
observed during the 12-month trial are consistent with those
observed during the initial 90-day efficacy period, including
conjunctival hemorrhages (subconjunctival petechiae) and cornea
verticillata.
- In addition to the primary efficacy
endpoint at 90 days, IOPs were measured at 8 a.m., 10 a.m., and 4
p.m. at months six, nine and twelve. Roclatan™ IOP lowering
exceeded that of both latanoprost and Rhopressa™ in a range from 1
to 3 mmHg. Levels of IOP lowering were consistent with those
observed in the Mercury 1 and Mercury 2 90-day efficacy results for
all arms of the study. Roclatan™ also demonstrated consistent
levels of IOP lowering across the 12-month study period.
- Roclatan™ reduced mean diurnal IOPs to
16 mmHg or lower in 60 percent of patients, a significantly higher
percentage than observed in the two comparator arms.
- The Rhopressa™ arm of the study
performed consistently with previous Phase 3 trials from both a
safety and efficacy perspective. Rhopressa™ also demonstrated
consistent levels of IOP lowering across the 12-month study period.
At baseline IOPs below 25 mmHg, Rhopressa™ IOP lowering was similar
to latanoprost at month 12.
“With these positive 12-month Mercury 1 data, we have again
demonstrated the consistent and well-understood performance of
Roclatan™ and Rhopressa™ from both a safety and efficacy
perspective. Roclatan™ has the potential to become the most
efficacious IOP-lowering therapy to enter the market, if approved,
bolstered by an overall favorable safety and tolerability profile.
We continue to expect to submit our Roclatan™ NDA (new drug
application) in the first half of 2018,” said Vicente Anido, Jr.,
Ph.D., Chairman and Chief Executive Officer at Aerie.
Dr. Anido continued, “This data readout represents the last in
our series of Phase 3 trials for both Roclatan™ and Rhopressa™ for
approval in the U.S., and we are now actively engaged in
preparations for the expected Rhopressa™ commercialization next
year.”
Richard A. Lewis, M.D., Aerie’s Chief Medical Officer, added,
“As a clinician, I am very excited about the responder analysis
data for Roclatan™ showing such a profound drop in IOP. We now have
a robust understanding of the Roclatan™ safety profile and expect
that clinicians will be highly satisfied with the 12-month safety
and efficacy data.”
About Roclatan™
Roclatan™ is a once-daily eye drop that combines Rhopressa™, as
described below, with latanoprost, a widely prescribed PGA. Based
on the Company’s preclinical studies and clinical trials to date,
Aerie believes that Roclatan™, 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, Roclatan™ has the potential to provide a greater
IOP-lowering effect than any currently approved glaucoma
product.
The first Phase 3 registration trial for Roclatan™, named
Mercury 1, is a 12-month safety and efficacy trial, which was just
completed and is the subject of this press release. Mercury 1 had a
successful 90-day efficacy readout in September 2016. The second
Phase 3 registration trial, named Mercury 2, is a 90-day efficacy
trial, which reported successful primary efficacy results in May
2017. The topline 90-day efficacy readouts for both Mercury 1 and
Mercury 2 demonstrated that Roclatan™ was statistically superior to
each of its components, thus achieving their primary clinical
endpoints. Aerie expects to submit a Roclatan™ NDA to the U.S. Food
and Drug Administration (FDA) in the first half of 2018. A third
Phase 3 registration trial, named Mercury 3, is expected to
commence in Europe in the third quarter of 2017. Mercury 3 is not
necessary for approval in the U.S., but rather to facilitate
regulatory approval and commercialization in Europe.
About Rhopressa™
Rhopressa™ (netarsudil ophthalmic solution) 0.02%, is a novel
eye drop that the Company believes, if approved, would become the
only once-daily product available that, based on Aerie’s
preclinical and clinical studies to date, specifically targets the
trabecular meshwork, the eye’s primary fluid drain and the diseased
tissue responsible for elevated IOP in glaucoma. Preclinical and
clinical studies have also demonstrated that Rhopressa™ lowers
episcleral venous pressure, which contributes approximately half of
IOP in healthy subjects. Further, based on Aerie’s preclinical
studies, Rhopressa™ may provide an additional mechanism that
reduces fluid production in the eye and therefore lowers IOP.
Biochemically, the active ingredient in Rhopressa™, netarsudil, has
been shown in Aerie studies to inhibit both Rho kinase (ROCK) and
norepinephrine transporter (NET). Recent preclinical studies have
also shown that Rhopressa™ may have disease-modifying properties,
including an anti-fibrotic effect of netarsudil on trabecular
meshwork cells and the potential to increase perfusion of the
trabecular meshwork.
The results of two Phase 3 registration trials (Rocket 2 and
Rocket 1) for Rhopressa™ were included in the NDA submission to the
FDA in February 2017. There were two additional Phase 3
registration trials for Rhopressa™, named Rocket 3 and Rocket 4.
Rocket 3 was a small 12-month safety-only study in Canada that was
not necessary for the NDA submission and for which enrollment has
been discontinued. Rocket 4, which was successfully completed in
April 2017, was designed to provide adequate six-month safety data
for regulatory filing purposes in Europe, and was also not
necessary 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 Roclatan™ (netarsudil/latanoprost
ophthalmic solution) 0.02%/0.005%, were also included in the
Rhopressa™ NDA submission as supportive. The FDA has set the
Prescription Drug User Fee Act (PDUFA) goal date for the completion
of the FDA’s review of the Rhopressa™ NDA for February 28,
2018.
Conference Call / Webcast Information
Aerie management will host a live conference call and webcast at
5:00 p.m. ET today to discuss the Roclatan™ Phase 3 12-month safety
and efficacy results from Mercury 1, including a review of the
associated slides that are posted on Aerie’s website,
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
48191718. 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 48191718. The telephone replay will be available
until July 26, 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 current product candidates are
once-daily intraocular pressure lowering therapies with novel
mechanisms of action to treat patients with glaucoma or ocular
hypertension. The NDA for Rhopressa™ (netarsudil ophthalmic
solution) 0.02% was submitted to the FDA in February 2017, and, in
May 2017, the FDA set the PDUFA goal date for the completion of the
FDA’s review of the Rhopressa™ NDA for February 28, 2018. Aerie’s
second product candidate, Roclatan™ (netarsudil/latanoprost
ophthalmic solution) 0.02%/0.005%, which is a fixed dose
combination of Rhopressa™ and widely prescribed PGA latanoprost,
achieved its primary efficacy endpoint in two Phase 3 registration
trials, named Mercury 1 and Mercury 2, and also achieved successful
12-month safety and efficacy results in Mercury 1. The Roclatan™
NDA submission is expected to take place in the first half of 2018.
Aerie is also focused on the development of additional product
candidates and technologies in ophthalmology.
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 and potential future 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 FDA or other regulatory authority
approval of, or other action with respect to, our product
candidates, including the expected timing of, and timing of
regulatory and/or other review of, filings for our product
candidates; our expectations regarding the commercialization and
manufacturing of our product candidates; the potential advantages
of our product candidates; our plans to pursue development of
additional product candidates and technologies in ophthalmology,
including 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; 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 or
technologies. 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, 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. The receipt of the PDUFA goal date notification does not
constitute FDA approval of the Rhopressa™ NDA, and there can be no
assurance that the FDA will complete its review by the PDUFA goal
date, that the FDA will not require changes or additional data,
whether as a result of recommendations, if any, made by any FDA
advisory committee or otherwise, that must be made or received
before it will approve the NDA, if ever, or that the FDA will
approve the NDA. 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170719006087/en/
Aerie PharmaceuticalsRichard Rubino,
908-947-3540rrubino@aeriepharma.comorBurns McClellan, Inc., on
behalf of Aerie PharmaceuticalsInvestorsAmi Bavishi,
212-213-0006abavishi@burnsmc.comorMediaJustin Jackson,
212-213-0006jjackson@burnsmc.com
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