Aerie Pharmaceuticals Initiates Phase 2 Clinical Trial of AR-1105 (Dexamethasone Intravitreal Implant) in Patients with Macular Edema Associated with Retinal Vein Occlusion

DURHAM, N.C.–(BUSINESS WIRE)–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.

Contacts

Media: Tad Heitmann 949-526-8747; [email protected]
Investors:
Ami Bavishi 908-947-3949; [email protected]