Three-Month Efficacy Results Expected Mid-2015; Potential to File New
Drug Application by Mid-2016
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 announced
that on July 11, dosing commenced of the first patients enrolled in the
Company's Phase 3 registration clinical trials of RhopressaTM,
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. Aerie anticipates total enrollment of approximately 1,300
patients in three Phase 3 registration trials of RhopressaTM.
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 RhopressaTM
compared to timolol. Timolol is the most widely used comparator in
registration trials for glaucoma. There will be two trials conducted in
the United States, named "Rocket 1" and "Rocket 2," and one safety-only
study in Canada, named "Rocket 3."
Brian Levy, O.D., M.Sc., Aerie's Chief Medical Officer, commented, "The
initiation of the RhopressaTM Phase 3 clinical trials follows
previous positive findings in Phase 2b trials, in which RhopressaTM
demonstrated strong and consistent IOP lowering, irrespective of the
patient's baseline IOP. In contrast, currently marketed IOP-lowering
agents, including prostaglandin analogues (PGAs), have been shown to be
less effective at lower baseline IOPs, as reported in published studies.
We believe this will be a key differentiation for RhopressaTM,
along with targeting the trabecular meshwork, which is the diseased
tissue in glaucoma. Furthermore, RhopressaTM has been shown
to lower episcleral venous pressure, which may add to the IOP-lowering
efficacy particularly at lower baseline IOPs."
Pending success of the studies and regulatory approval, Aerie expects
RhopressaTM 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 significant majority of patients with
glaucoma and ocular hypertension. Additionally, the Company believes
RhopressaTM may be used as the add-on product of choice for
patients on PGA therapy requiring further IOP lowering, due to its
strong and consistent IOP-lowering effect, once-daily dosing and ability
to target the trabecular meshwork. PGAs target the secondary uveoscleral
outflow mechanism, which is not the diseased tissue in glaucoma. Aerie
also believes 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 with PGAs.
"The advancement of RhopressaTM into pivotal trials,
following our recent reporting of positive RoclatanTM Phase
2b results last month, underscores Aerie's commitment to delivering
innovative medicines that hold promise for individuals with glaucoma,"
said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at
Aerie. "Given our current timelines, we expect to report top-line
three-month efficacy results from the RhopressaTM Phase 3
clinical program in the middle of next year, and assuming successful
data, we would be on track to file an NDA by mid-2016. With each
advancement, we can further maximize the value of our lead programs in
anticipation of regulatory approvals and ultimate commercialization."
RhopressaTM 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. Recent 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
In the Company's Phase 2b clinical trial, which was successfully
completed in June 2013, RhopressaTM 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, RhopressaTM
demonstrated a consistent mean IOP-lowering effect irrespective of the
baseline IOPs of the patients entered into the trial. This
differentiates RhopressaTM 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 significant majority of glaucoma patients
have low to moderately elevated IOPs of 26 mmHg or below at the time of
diagnosis. In the RoclatanTM Phase 2b trial recently
completed in June 2014, RhopressaTM performed with similar
results as it had in its Phase 2b trial completed in June 2013 and in
addition demonstrated additive efficacy when used in combination with
latanoprost, the most commonly prescribed PGA.
Pending successful advancement of the Phase 3 registration studies,
three-month efficacy results are expected to be released in mid-2015. If
the trials are successful, the Company expects to submit a New Drug
Application filing by mid-2016.
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 commencing two Phase 3 registration trials in
the United States, named "Rocket 1" and "Rocket 2," where the primary
efficacy endpoint will be to demonstrate non-inferiority of IOP lowering
for RhopressaTM compared to timolol, along with a third Phase
3 registration safety-only trial, named "Rocket 3," in Canada. The
Company also recently completed a Phase 2b clinical trial where RoclatanTM
met the primary efficacy endpoint, demonstrating the statistical
superiority of RoclatanTM to each of its components.
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Richard Rubino, 908-470-4320
McClellan, Inc., on behalf of Aerie Pharmaceuticals
Source: Aerie Pharmaceuticals, Inc.
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