|[June 25, 2014]
Aerie Pharmaceuticals Reports RoclatanTM Phase 2b Results Achieve All Clinical Endpoints
BEDMINSTER, N.J. & RESEARCH TRIANGLE PARK, N.C. & NEWPORT BEACH, 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 results of its Phase 2b trial for once-daily,
quadruple-action RoclatanTM, a combination of Aerie's
triple-action RhopressaTM with latanoprost, a prostaglandin
analogue (PGA). Management will host a conference call to discuss these
results at 8:00 a.m. ET today.
Quadruple-Action RoclatanTM Phase 2b
RoclatanTM achieved its primary efficacy endpoint of
statistically significant superiority over each of its components on
day 29. The Phase 2b 28-day clinical trial included 297 patients. The
baseline intraocular pressures (IOPs) tested in the study ranged from
22 to 36 millimeters of mercury (mmHg). RoclatanTM lowered
mean diurnal IOP on day 29 from 25.1 mmHg at baseline to 16.5 mmHg, a
34 percent decrease in IOP. RoclatanTM mean diurnal IOP
reduction on day 29 was approximately 2 mmHg greater than latanoprost.
RoclatanTM efficacy exceeded that of latanoprost, the most
widely prescribed glaucoma drug, by 1.6 to 3.2 mmHg across each time
point evaluated during the study (8am, 10am, 4pm on days 8, 15 and
29). These results were statistically significant at all time points
with p-values less than 0.05.
The most common RoclatanTM adverse event was hyperemia, or
eye redness, which was reported in 40 percent of patients and was
scored as mild for the large majority of the RoclatanTM
In addition to the significant RoclatanTM findings, other
performance highlights of the Phase 2b trial include:
On day 29, 50 percent of RoclatanTM patients compared
to 28 percent of latanoprost patients experienced a 35 percent or
greater decrease in mean diurnal IOP from baseline.
On day 29, 46 percent of RoclatanTM patients compared
to 18 percent of latanoprost patients had a mean diurnal IOP of 16
mmHg or less.
The RhopressaTM arm of the RoclatanTM study
performed similarly to the results observed in the RhopressaTM
Phase 2b study, lowering mean diurnal IOP on day 29 by 6.3 mmHg from
"We are very impressed by the RoclatanTM Phase 2b results.
This product has demonstrated great promise to potentially become the
most effective IOP-lowering product on the market, creating new hope for
glaucoma sufferers. With this success we believe we have an approvable
product, and Phase 3 preparatory activities for RoclatanTM are
commencing immediately. The entire Aerie team remains focused on moving
forward towards Phase 3 registration trials for RoclatanTM,
and initiating the Phase 3 registration trials for our other innovative
product, triple-action RhopressaTM," said Vicente Anido, Jr.,
Ph.D., Chairman and Chief Executive Officer at Aerie.
With regard to commercialization potential, Dr. Anido added, "With these
strong data, we are even more confident that our products have
blockbuster potential. We continue to expect to market our products
through our own sales force in North America, and plan to commence
licensing discussions for commercialization outside of North America."
Richard L. Lewis, MD, a glaucoma specialist in Sacramento, California,
President of the American Society of Cataract and Refractive Surgeons
(ASCRS), and Chairman of Aerie's Scientific Advisory Board added, "These
powerful data suggest that we are on the verge of a true breakthrough in
IOP-lowering agents for the treatment of glaucoma. Practitioners will
welcome the quadruple-action MOAs, including the targeting of the
trabecular meshwork, the diseased tissue in glaucoma, and the reduction
of episcleral venous pressure."
Aerie Product Summary
Aerie's first-in-class product candidates are all single drop,
once-daily medications that are well tolerated and have shown no
systemic drug-related adverse events. Aerie fully owns its product
candidates, has no licenses, and has patent protection for both use and
composition of matter through 2030.
Roclatan™ is a once-daily eye drop that combines our triple-action
Rhopressa™ (discussed below) with latanoprost, a prostaglandin analogue
that is the most widely prescribed glaucoma drug. I approved, we
believe that Roclatan™ would be the first glaucoma product to lower IOP
through all known actions: (i) increasing fluid outflow through the
trabecular meshwork (TM) or primary drain, (ii) increasing fluid outflow
through the uveoscleral pathway or secondary drain, (iii) reducing fluid
production in the eye and (iv) reducing episcleral venous pressure (EVP).
We believe that Roclatan™, if approved, would be the only glaucoma
product that covers the full spectrum of known IOP-lowering mechanisms,
giving it the potential to provide a greater IOP-lowering effect than
any currently approved glaucoma product. Therefore, we believe
Roclatan™, if approved, could compete in both the PGA and non-PGA
markets and become the product of choice for patients requiring maximal
IOP lowering, including those with IOPs in excess of 26 mmHg and those
who present with significant disease progression despite currently
A successful 28-day Phase 2b clinical trial for Roclatan™ was recently
completed, and preparatory steps for Phase 3 registration trials are
expected to commence immediately.
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 TM, the eye's primary fluid drain and the
diseased tissue responsible for elevated intraocular pressure (IOP) in
glaucoma. Recent preclinical results have demonstrated that Rhopressa™
also lowers EVP, which contributes approximately half of IOP in healthy
subjects. Further, we believe Rhopressa™ provides an additional
mechanism which reduces fluid production in the eye and therefore lowers
IOP. Biochemically, Rhopressa™ is known to inhibit both Rho Kinase
(ROCK) and norepinephrine transporter (NET (News - Alert)).
If successful, we expect Rhopressa™ to compete against PGA products as
an initial therapy for patients with IOPs of 26 mmHg or below at the
time of diagnosis, which represents the majority of patients with
glaucoma and ocular hypertension. Additionally, we believe Rhopressa™
may be used as the add-on product of choice for patients on PGA therapy
requiring further IOP lowering, due to its high efficacy, once daily
dosing and ability to target the TM. PGAs target the secondary
uveoscleral outflow mechanism, which is not the diseased tissue in
glaucoma. We also believe Rhopressa™ may become the product of choice
where PGAs may be contraindicated and for patients who are not
responsive to PGAs or choose to avoid the cosmetic issues associated
In our Phase 2b clinical trial, which was successfully completed in June
2013, Rhopressa™ demonstrated a strong IOP-lowering effect, with mean
IOP reductions of 5.7 and 6.2 mmHg on days 28 and 14, respectively. In
addition, Rhopressa™ demonstrated a consistent mean IOP-lowering effect
irrespective of the baseline IOPs of the patients entered into the
trial. This differentiates Rhopressa™ from currently marketed
IOP-lowering agents such as market-leading PGAs and beta blockers, which
have their highest effect at higher baseline IOPs, while losing efficacy
as the baseline diminishes, as shown in published studies. This is
significant given that the majority of glaucoma patients have low to
moderately elevated IOPs of 26 mmHg or below at the time of diagnosis.
In the Roclatan™ Phase 2b trial recently completed in June 2014,
Rhopressa™ performed with similar results as it had in its Phase 2b
trial completed in June 2013.
Rhopressa™ is expected to begin three Phase 3 registration trials in
July 2014, with total expected enrollment of approximately 1,300
patients. The trials will measure efficacy over three months and safety
over 12 months. The primary efficacy endpoint of the trials will be to
demonstrate non-inferiority of IOP lowering for Rhopressa™ (dosed once
daily and twice daily) compared to timolol (dosed twice daily). There
will be two trials conducted in the U.S., and one safety-only study in
Canada. Timolol is the most widely used comparator in registration
trials for glaucoma, and is also the most widely prescribed add-on
therapy to PGAs.
Assuming the trials commence as expected in July 2014, three-month
efficacy results are expected to be released in mid-2015, and if the
trials are successful, we expect to submit our NDA filing in mid-2016.
Conference Call / Web Cast Information
Aerie management will host a live conference call and webcast at 8:00
a.m. Eastern Time today to discuss the RoclatanTM Phase 2b
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 RoclatanTM Phase 2b
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 (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 66255242. 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
66255242. The telephone replay will be available until July 9, 2014.
About Aerie Pharmaceuticals, Inc.
Aerie is a clinical-stage pharmaceutical company focused on the
discovery, development and commercialization of first-in-class glaucoma
therapies. The Company is preparing for two Phase 3 registration trials
in the U.S. where the primary efficacy endpoint will be to demonstrate
non-inferiority of IOP lowering for Rhopressa™ (dosed once daily and
twice daily) compared to timolol (dosed twice daily), along with a third
Phase 3 registration safety-only trial in Canada. The Company also
recently completed a Phase 2b clinical trial where RoclatanTM
met the primary efficacy endpoint, demonstrating the statistical
superiority of Roclatan™ to each of its components.
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