Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) (Aerie), an ophthalmic
pharmaceutical company focused on the discovery, development and
commercialization of first-in-class therapies for the treatment of
patients with open-angle glaucoma, retinal diseases and other
diseases of the eye, today announced the commencement of patient
dosing in a Phase 2 clinical trial of AR-1105, its investigational
dexamethasone intravitreal implant, in patients with macular edema
due to retinal vein occlusion (RVO).
This Phase 2 study (AR1105-CS201) will be conducted at
approximately 20 centers in the United States and enroll up to
45 patients. The primary objectives of the trial are to evaluate
the safety, tolerability and efficacy of the AR-1105 dexamethasone
intravitreal implant. The study will be conducted in two stages. In
the initial safety stage, up to 5 patients will be enrolled in a
single cohort to receive clinical formulation #1 (CF-1), delivering
a 340µg dose of dexamethasone in a single intravitreal injection.
In Stage 2, up to 40 patients will be randomized 1:1 to receive
either CF-1 or a second clinical formulation, CF-2, which delivers
the same dose of dexamethasone over a longer period. Safety and
efficacy will be evaluated at six months. More information about
the study is available at www.clinicaltrials.gov under the study
designation NCT 03739593.
“This is a proof of concept study for AR-1105 and for the retina
portfolio we are building based on two enabling technologies, the
bio-erodible polymers we are developing with DSM and our PRINT®
manufacturing platform,” said Vicente Anido, Jr., Ph.D.,
Chairman and Chief Executive Officer. “The results of this trial
should allow us to optimize the formulation of AR-1105 to achieve
this clinical objective in Phase 3 studies. By the end of this
quarter, we also plan to file an Investigational New Drug (IND)
application for our second sustained delivery retina product,
AR-13503 Implant, a bio-erodible implant delivering a Rho
kinase/Protein kinase C inhibitor for the treatment of wet
age-related macular degeneration and diabetic macular edema.”
About AR-1105
AR-1105 is a bio-erodible implant that is designed to steadily
release the steroid dexamethasone over a six-month period. It is
administered by intravitreal injection, a commonly-used, in-office
treatment method. In addition to its six-month duration of effect,
the potential benefits of AR-1105 compared to other intravitreal
steroid products include improved administration with a smaller 25G
needle and the potential for fewer adverse events due to lower peak
drug levels. The market for retinal disease therapeutics in the
United States, which is dominated by anti-VEGF agents, was
approximately $6 billion in 2018. The intravitreal steroid segment
represented approximately $200 million of that total.
About Aerie Pharmaceuticals, Inc.
Aerie is an ophthalmic pharmaceutical company focused on the
discovery, development and commercialization of first-in-class
therapies for the treatment of patients with open-angle glaucoma,
retinal diseases and other diseases of the eye. Aerie's first
product, Rhopressa® (netarsudil ophthalmic solution) 0.02%, a
once-daily eyedrop approved by the U.S. Food and Drug
Administration (FDA) for the reduction of elevated intraocular
pressure (IOP) in patients with open-angle glaucoma or ocular
hypertension, was launched in the United States in April 2018. In
clinical trials of Rhopressa®, the most common adverse reactions
were conjunctival hyperemia, corneal verticillata, instillation
site pain, and conjunctival hemorrhage. More information about
Rhopressa®, including the product label, is available at
www.rhopressa.com. Aerie’s second product for the reduction of
elevated intraocular pressure (IOP) in patients with open-angle
glaucoma or ocular hypertension, Rocklatan™ (netarsudil and
latanoprost ophthalmic solution) 0.02%/0.005%, the first and only
fixed-dose combination of Rhopressa® and the widely-prescribed PGA
(prostaglandin analog) latanoprost, has been approved by the FDA
and is expected to be launched in the United States in the second
quarter of 2019. In clinical trials of Rocklatan™ the most common
adverse reactions were conjunctival hyperemia, corneal
verticillata, instillation site pain, and conjunctival hemorrhage.
More information about Rocklatan™ including the product label, is
available at www.rocklatan.com. Aerie continues to focus on global
expansion and the development of additional product candidates and
technologies in ophthalmology, including for wet age-related
macular degeneration and diabetic macular edema. More information
is available at www.aeriepharma.com.
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: our expectations
regarding the commercialization and manufacturing of Rhopressa® and
Rocklatan™ or any future product candidates, including the timing,
cost or other aspects of the commercial launch of Rhopressa® and
Rocklatan™ or any future product candidates; our commercialization,
marketing, manufacturing and supply management capabilities and
strategies; the success, timing and cost of our ongoing and
anticipated preclinical studies and clinical trials for Rhopressa®
and Rocklatan™, with respect to regulatory approval outside of the
United States or additional indications, and any future product
candidates, including statements regarding the timing of initiation
and completion of the studies and trials; such as statements in
this press release regarding any expected clinical trials for
AR-1105 or AR-13503 and results of such 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,
as applicable, Rhopressa®, Rocklatan™ or any future product
candidates, including the expected timing of, and timing of
regulatory and/or other review of, filings for, as applicable,
Rhopressa®, Rocklatan™ or any future product candidates; the
potential advantages of Rhopressa® and Rocklatan™ or any future
product candidates; our plans to pursue development of additional
product candidates and technologies within and beyond
ophthalmology; our plans to explore possible uses of our existing
proprietary compounds beyond glaucoma, including development of our
retina program; 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, 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, FDA approval of
Rhopressa® and Rocklatan™ do not constitute FDA approval of
AR-1105, AR-13503 or any future product candidates, and there can
be no assurance that we will receive FDA approval for AR-1105,
AR-13503 or any future product candidates. FDA approval of
Rhopressa® and Rocklatan™ also do not constitute regulatory
approval of Rhopressa® and Rocklatan™ in jurisdictions outside the
United States and there can be no assurance that we will receive
regulatory approval for Rhopressa® and Rocklatan™ in jurisdictions
outside the United States. 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: https://www.businesswire.com/news/home/20190318005192/en/
Media: Tad Heitmann 949-526-8747;
theitmann@aeriepharma.comInvestors: Ami Bavishi 908-947-3949;
abavishi@aeriepharma.com
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