First-In-Human Clinical Study Will be
Initiated Later in Second Quarter 2019
Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), 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 the U.S. Food and Drug
Administration (FDA) has reviewed the Investigational New Drug
Application (IND) for AR-13503, a novel multi-kinase (Rho
kinase/Protein kinase C (ROCK/PKC)) inhibitor sustained-release
implant (the AR-13503 implant) and it is now in effect, allowing
Aerie to initiate human studies in the treatment of neovascular
age-related macular degeneration (nAMD) and diabetic macular edema
(DME). The IND was submitted in March 2019. Aerie expects to
initiate a first-in-human clinical study later in the second
quarter of 2019.
The AR-13503 implant is a bio-erodible polyesteramide polymer
implant that provides controlled release of AR-13503 over a
sustained period. It is designed to be administered approximately
once every six months by intravitreal injection. Preclinical
studies suggest that AR-13503 has the potential to inhibit
angiogenesis, preserve the blood retinal barrier, and reduce
retinal fibrosis in retinal diseases such as nAMD and DME, while
potentially reducing the treatment burden associated with more
frequent intravitreal injections.
“While the standard-of-care anti-VEGF therapies are effective
for many patients with nAMD and DME, there are many patients who do
not respond adequately to these therapies or who lose their initial
gains in vision over time. By targeting multiple disease processes
that underlie progression in these common, sight-threatening
retinal diseases, our research suggests that ROCK/PKC inhibitors
such as AR-13503 may prove useful as alternative or additive
therapies to the currently-available treatments,” said Vicente
Anido, Jr., Ph.D., Chairman and Chief Executive Officer. “The
AR-13503 implant marks our second foray into the retina space, with
this product candidate leveraging both our scientific leadership in
the creation of small-molecule kinase inhibitors for disease
intervention along with our proprietary ophthalmic drug delivery
platform.”
About Retinal Disease
The retina is a thin membrane lining the back of the eye
composed of highly-specialized cells that convert visible light
into electrical impulses that reach the brain through the optic
nerve. There are a variety of diseases, including progressive
disorders such as age-related macular degeneration (AMD) and
diabetic macular edema (the macula is the central portion of the
retina), that can damage the retina and cause visual impairment or
permanent blindness. In the United States, AMD is the leading cause
of significant visual acuity loss in people over age 50 and
diabetic retinopathy is the most common cause of irreversible
blindness among working-age people. As a result, the retinal
disease market is the largest therapeutic category in
ophthalmology, with revenues in the United States reaching
approximately $6.0 billion in 2018. Because current medical
therapies are not adequately effective for many patients and do not
stop disease progression, new treatment options are needed.
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
(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; 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
such as AR-13503 or AR-1105, 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
such as AR-13503 or AR-1105, the potential advantages of
Rhopressa® and Rocklatan® or any future product candidates
such as AR-13503 or AR-1105, 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. FDA approval of Rhopressa® and Rocklatan® 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. In addition, the acceptance of the IND discussed in
this press release does not constitute FDA approval of AR-13503 and
the outcome of later clinical trials for AR-13503 may not be
sufficient to submit an NDA with the FDA or to receive FDA
approval. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190425005174/en/
Media: Tad Heitmann
949-526-8747; theitmann@aeriepharma.comInvestors: Ami Bavishi
908-947-3949; abavishi@aeriepharma.com
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