First-In-Human Clinical Study Will be Initiated Later in Second
Quarter 2019
DURHAM, N.C.–(BUSINESS WIRE)–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.
Contacts
Media: Tad Heitmann 949-526-8747; theitmann@aeriepharma.com
Investors:
Ami Bavishi 908-947-3949; abavishi@aeriepharma.com