press release
Aerie Pharmaceuticals’
ROCK Inhibitor, AR-12286, Demonstrates Positive Results in Glaucoma Patients in
a Phase 2a Study Novel Drug has Potential to Create Significant Improvement in Function of Diseased
Tissue
Bridgewater, NJ and
Research Triangle Park, NC – October 22, 2009 – Aerie Pharmaceuticals,
a biotechnology company focused on the discovery and development of novel
treatments for glaucoma, today announced positive results from a Phase 2a study
of its Rho-kinase (ROCK) inhibitor, AR-12286. The study evaluated the safety,
tolerability and efficacy of three different doses of AR-12286 in 88 patients
with primary open angle glaucoma or ocular hypertension. According to the study
results, AR-12286 was safe and well-tolerated. There were no serious side
effects reported in the study; mild to moderate and transient hyperemia (eye
redness) was observed in a minority of patients. In addition, the Phase 2a
study achieved statistical significance in demonstrating lowered intraocular
pressure (IOP) with both once-daily and twice-daily treatment. AR-12286
achieved a maximum change of mean IOP of 28% from baseline, which is comparable
to, or exceeds, pressure lowering attained by the most commonly used glaucoma
drugs as reported in other studies. The Company plans on submitting the full
data set for presentation at an upcoming medical meeting. David L. Epstein, M.D., Professor and Chairman, Department of
Ophthalmology, Duke University Medical Center, and Co-Founder of Aerie
Pharmaceuticals, commented, “I am greatly encouraged by the results of the
Phase 2a study. ROCK inhibitors such as AR-12286 act directly on the diseased
tissue that is responsible for elevated intraocular pressure, the trabecular
meshwork, and now it has been shown in patients to safely and effectively lower
IOP. The ability to target diseased tissue and act directly to restore normal
function is a fundamental tenet of Medicine and one which current glaucoma
therapies do not address. AR-12286 may have broad implications in glaucoma
therapy and could offer the next major advancement in the field since the
approval of latanoprost (Xalatan) in 1996.” There are currently no ROCK
inhibitors on the market, and AR-12286 is the first in class to report positive
safety, tolerability and efficacy data in glaucoma patients. The Phase 2a study was a U.S., multi-center, randomized,
double-masked, placebo-controlled study in which patients were randomly
assigned to receive one of three doses of AR-12286 or placebo. Patients were
first dosed once daily and then twice daily and evaluated over a three-week
treatment period. Thomas van Haarlem, M.D., President and Chief Executive
Officer of Aerie Pharmaceuticals, commented, “We are very pleased with these
results and will soon initiate a Phase 2b study with once-daily dosing in a
larger patient group in order to determine the optimal dose to take forward
into Phase 3 registration studies. Aerie’s goal is to advance the quality of
glaucoma care and the clinical success of AR-12286 represents a significant
step. We have several other innovative R&D programs underway with
significant therapeutic potential, including the recent discovery by Aerie
scientists of a new class of dual-action glaucoma drugs.” About AR-12286 AR-12286 is a highly selective Rho-kinase (ROCK) inhibitor
designed to lower intraocular pressure by improving outflow of fluid via the
trabecular pathway with the potential of restoring normal function. This class
of compounds acts directly on diseased tissue, the trabecular meshwork (TM),
which undergoes pathological changes in patients with primary open angle
glaucoma. An altered TM morphology eventually restricts the drainage of fluid
from the eye, which causes an increase in intraocular pressure and ultimately
damage to the optic nerve. ROCK inhibitors return the TM to a state that allows
normal drainage of ocular fluid and thereby reduces pressure in the eye. About Glaucoma Glaucoma represents a group of eye diseases often marked by
elevated intraocular pressure, which, if left untreated, can lead to
progressive loss of vision and eventually blindness. Over four million people
are estimated to have glaucoma in the United States, but only half receive a
diagnosis. Approximately 120,000 people are blind from glaucoma, making
glaucoma the second most common cause of blindness in the U.S. For more
information on glaucoma, please visit the National Eye Institute’s website at
www.nei.nih.gov. About Aerie Pharmaceuticals Aerie Pharmaceuticals is a privately held, clinical-stage
biotechnology company dedicated to the discovery and development of novel
treatments for glaucoma. Aerie’s internal research and development engine has
generated an innovative glaucoma pipeline. In addition to AR-12286, the
Company’s Rho-kinase (ROCK) inhibitor, the pipeline includes AR-13165, a novel
product candidate with a dual mechanism of action that represents the first of
a new proprietary class of glaucoma drugs. AR-13165 is currently in
preclinical, IND-enabling studies. An ocular implant for long-term drug
delivery is also being advanced towards the clinic. The Company is located in
Bridgewater New Jersey and Research Triangle Park North Carolina. For more information on Aerie, please visit the Company’s
website at www.aeriepharma.com. Contacts
Aerie Pharmaceuticals
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