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 that patient enrollment in its
Phase 2 clinical trial of AR-1105 in patients with macular edema
due to retinal vein occlusion (RVO) is complete several weeks ahead
of schedule. AR-1105 is an investigational sustained-release,
bio-erodible intravitreal implant containing dexamethasone.
The Phase 2 study (AR-1105-CS201), conducted at 19 centers in
the United States, had an enrollment target of 45 patients. The
trial is evaluating two formulations of AR-1105 (CF-1 and CF-2)
that differ in the duration of dexamethasone release. A few
additional patients are currently being screened and, if they are
randomized, could bring the total number of patients in the final
evaluation to a maximum of 49.
The primary objectives of the trial are to evaluate the safety,
tolerability and efficacy of the AR-1105 dexamethasone intravitreal
implant. 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.
“We are grateful to our investigators and the patients who have
enrolled in this proof-of-concept study for our proprietary
sustained-release technology,” said Vicente Anido, Jr., Ph.D.,
Chairman and Chief Executive Officer. “We plan to conduct an
interim analysis when the first 20 patients have reached the six
month timepoint, which should be before the end of this year,
making preliminary data available in 2020. The final patient visit
should take place in Q2 2020. Meanwhile, our study team will be
consulting with regulatory agencies in both the United States and
the European Union as they move toward the design of our next trial
of AR-1105 in DME.”
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-vascular endothelial
growth factor 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 eye drop 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 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 now available in the United States. 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: 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 current or 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 the clinical trials for AR-1105 and results
of such clinical trials; 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 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, or any future product candidates, and there can be no
assurance that we will receive FDA approval for AR-1105, 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/20191024005062/en/
Media: Tad Heitmann 949-526-8747; theitmann@aeriepharma.com
Investors: Ami Bavishi 908-947-3949; abavishi@aeriepharma.com
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