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, ocular surface diseases and
retinal diseases, today reported positive topline results for the
Company’s Phase 2 clinical trial evaluating AR-1105 (dexamethasone
intravitreal implant) in patients with macular edema associated
with retinal vein occlusion.
AR-1105 Phase 2 Highlights
- The Phase 2 clinical trial (AR-1105-CS201) was conducted at 19
centers in the United States. A total of 49 patients completed the
study.
- The objective of the Phase 2 clinical trial was to evaluate two
formulations of AR-1105, clinical formulation #1 (CF-1) and
clinical formulation #2 (CF-2) with different steroid release
profiles. The clinical trial was conducted in two stages. In the
initial safety stage, five patients were enrolled in a single
cohort to receive CF-1, delivering a 340µg dose of dexamethasone in
a single intravitreal injection. In stage 2, 44 patients were
randomized 1:1 to receive either CF-1 or CF-2.
- The results demonstrated positive and sustained treatment
effects with both formulations as shown by increases in best
corrected visual acuity and reductions in macular edema. Peak
efficacy was observed earlier with CF-1, while CF-2 demonstrated a
longer overall duration of effect of up to six months.
- Both formulations, CF-1 and CF-2, were well tolerated with no
unexpected safety findings.
- Adverse events were consistent with other corticosteroid
treatments and intravitreal injection procedures.
- Further details will be provided at an upcoming ophthalmology
conference.
“The results of this study are very exciting. The formulation of
AR-1105 appears to indicate that this therapy candidate may have
the potential to deliver a long-acting treatment for patients with
macular edema secondary to retinal vein occlusion,” said Michael
Singer, M.D., Director of Clinical Research at Medical Center
Ophthalmology Associates and Clinical Professors of Ophthalmology
at the University of Texas Health Science Center in San
Antonio.
“We are very pleased with the AR-1105 clinical trial results,
our first successful clinical trial from our retina program. The
profiles of the different cohorts demonstrate the flexibility of
our PRINT® sustained release technology platform in enhancing the
management and durability of treatment effects. This product
candidate would be a welcome addition to currently available
steroid treatments with its potential for five to six months of
sustained efficacy. Additionally, achieving up to six months of
sustained efficacy is an important hurdle for Aerie as it would
help validate the broad potential of our sustained release
technology,” said Vicente Anido, Jr., Ph.D., Chairman and Chief
Executive Officer at Aerie. “As we have previously stated, we do
not plan to initiate any new clinical trials for this product
candidate until the second half of 2021, after we have seen the
results of our other clinical trial programs, including our
AR-13503 sustained release implant for wet age-related macular
degeneration and diabetic macular edema, and AR-15512 for dry eye.
In the interim, we plan to discuss the results with retina
specialists as well as the regulatory agencies in both the United
States and the European Union to determine the optimal path forward
for AR-1105.”
About AR-1105
The product candidate AR-1105 is a bio-erodible implant that, if
approved, 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 duration of effect, AR-1105 offers the potential for a
favorable safety profile based on peak drug levels. The market for
retinal disease therapeutics totals nearly $7 billion in the United
States and $4 billion in Europe.
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,
ocular surface diseases and retinal diseases. 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 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, was launched in the United States in May 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 in this release include statements
regarding our intentions, beliefs, projections, outlook, analyses
or current expectations concerning, among other things: the
duration and severity of the coronavirus disease (COVID-19)
outbreak, including the impact on our clinical and commercial
operations, demand for our products and financial results and
condition of our global supply chains; our expectations regarding
the commercialization and manufacturing of Rhopressa®, Rocklatan®,
Rhokiinsa® and Roclanda® or any current or future product
candidates, including the timing, cost or other aspects of their
commercial launch; our commercialization, marketing, manufacturing
and supply management capabilities and strategies in and outside of
the United States; 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, 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 any expected clinical trials for AR-15512
(formerly AVX-012), AR-1105 or AR-13503 and the results of such
clinical trials; our expectations regarding the effectiveness of
Rhopressa®, Rocklatan®, Rhokiinsa®, Roclanda® or any current or
future product candidates; 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 current or 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 current or future product candidates; the potential
advantages of Rhopressa® and Rocklatan® or any current or future
product candidates; our plans to pursue development of additional
product candidates and technologies; 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. In
particular, the topline data presented herein is preliminary and
based solely on information available to us as of the date of this
press release and additional information about the results may be
disclosed at any time. Additionally, FDA approval of Rhopressa® and
Rocklatan® and EMA approval of Rhokiinsa® do not constitute
regulatory approval of Rhopressa® and Rocklatan® in other
jurisdictions, including EMA approval of Roclanda®, and there can
be no assurance that we will receive regulatory approval for
Rhopressa® and Rocklatan® in such other jurisdictions, including
EMA approval of Roclanda®. In addition, FDA approval of Rhopressa®
and Rocklatan® do not constitute FDA approval of our current or any
future product candidates, and there can be no assurance that we
will receive FDA approval for our current or any future product
candidates. Furthermore, EMA acceptance of the MAA for Roclanda®
does not constitute EMA approval of Roclanda®, and there can be no
assurance that we will receive EMA approval of Roclanda®. In
addition, the acceptance of the INDs by the FDA for AR-15512,
AR-1105 and AR-13503 do not constitute FDA approval of AR-15512,
AR-1105 or AR-13503, respectively, and the outcomes of later
clinical trials for AR-15512, AR-1105 or AR-13503 may not be
sufficient to submit an NDA with the FDA or to receive FDA
approval. 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). 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/20200727005023/en/
Media: Tad Heitmann 949-526-8747; theitmann@aeriepharma.com
Investors: Ami Bavishi 908-947-3949; abavishi@aeriepharma.com
Aerie Pharmaceuticals (NASDAQ:AERI)
Historical Stock Chart
From Mar 2024 to Apr 2024
Aerie Pharmaceuticals (NASDAQ:AERI)
Historical Stock Chart
From Apr 2023 to Apr 2024