PDUFA Date is June 21, 2023
Planned U.S. Launch of ADX-2191 in Second Half
of 2023, Pending Approval by the FDA
ADX-2191 with Potential to be the First
FDA-Approved Drug Available for Patients Suffering from Primary
Vitreoretinal Lymphoma
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today
announced that the U.S. Food and Drug Administration (FDA) accepted
for Priority Review the New Drug Application (NDA) for ADX-2191
(methotrexate injection, USP), an investigational drug candidate,
for the treatment of primary vitreoretinal lymphoma. The FDA
assigned a Prescription Drug User Fee Act (PDUFA) date of June 21,
2023. The FDA noted that no potential filing review issues have
been identified.
“The FDA’s decision to grant Priority Review with a PDUFA date
four months from NDA acceptance underscores the significant need
for an FDA-approved treatment of primary vitreoretinal lymphoma, a
rare but potentially fatal cancer,” stated Todd C. Brady, M.D.,
Ph.D., Aldeyra’s President and Chief Executive Officer. “We are
working closely with the FDA during the review process to bring
ADX‑2191 to patients as quickly as possible, and plan to launch
ADX-2191 in the United States in the second half of this
year, pending approval by the FDA.”
The NDA submission is supported by a combination of more than
three decades of published literature on the safety and efficacy of
methotrexate, the active ingredient of ADX‑2191, for the treatment
of primary vitreoretinal lymphoma, in addition to safety data from
the recently completed Phase 3 GUARD Trial of ADX-2191 in patients
with proliferative vitreoretinopathy. During the Phase 3 GUARD
Trial, no safety signals were observed, and ADX-2191 was well
tolerated; there were no observed treatment-emergent serious
adverse events. The most common adverse event associated with
ADX‑2191 treatment was punctate keratitis, a frequently observed
side effect of intravitreal methotrexate, that was most commonly
mild in severity.
About ADX-2191
ADX-2191 (methotrexate injection, USP) is a sterile,
non-compounded intravitreal formulation of methotrexate for the
potential prevention or treatment of specific rare retinal
diseases, including primary vitreoretinal lymphoma, proliferative
vitreoretinopathy, and retinitis pigmentosa. The ADX-2191
intravitreal formulation is preservative-free, is designed to be
vitreous-compatible, and is optimized for excipient composition,
viscosity, density, tonicity, pH, concentration, and volume of
administration. ADX-2191 has received FDA Orphan Drug Designation
for the prevention of proliferative vitreoretinopathy, and for the
treatment of primary vitreoretinal lymphoma and retinitis
pigmentosa.
About Primary Vitreoretinal Lymphoma
Primary vitreoretinal lymphoma is a rare, aggressive, and
potentially fatal retinal cancer that is diagnosed in approximately
300 to 600 patients in the United States per year. The median
survival for newly diagnosed patients is less than five years. No
approved treatments are currently available, though intravitreal
injection of compounded methotrexate represents the current
standard of care.
About Aldeyra
Aldeyra Therapeutics is a clinical-stage biotechnology company
developing innovative therapies designed to treat immune-mediated
diseases. Our approach is to discover and develop pharmaceuticals
that modulate immunological systems, instead of directly inhibiting
or activating single protein targets, with the goal of optimizing
multiple pathways at once while minimizing toxicity. Our product
candidates include RASP (reactive aldehyde species) modulators
ADX-629, ADX-246, ADX-248, and chemically related molecules for the
potential treatment of systemic and retinal immune-mediated
diseases. Our pre-commercial product candidates are reproxalap, a
RASP modulator for the potential treatment of dry eye disease
(under U.S. Food and Drug Administration New Drug Application
review) and allergic conjunctivitis, and ADX-2191, a novel
formulation of intravitreal methotrexate for the potential
treatment of primary vitreoretinal lymphoma (under U.S. Food and
Drug Administration New Drug Application review), proliferative
vitreoretinopathy, and other rare sight-threatening retinal
diseases. For more information, visit https://www.aldeyra.com/ and
follow us on LinkedIn, Facebook, and Twitter.
Safe Harbor Statement
This release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including, but not limited to, statements relating to the
likelihood and timing of the FDA’s potential approval of the NDA
for ADX-2191 by the PDUFA date of June 21, 2023, or at any other
time and the potential profile, the adequacy of the data included
in the NDA submission for ADX-2191, the timing of the potential
launch of ADX-2191, if approved, for treatment of primary
vitreoretinal lymphoma, benefit and market size of ADX-2191 in
primary vitreoretinal lymphoma should the NDA for ADX-2191 be
approved by the FDA. Aldeyra intends such forward-looking
statements to be covered by the safe harbor provisions for
forward-looking statements contained in Section 21E of the
Securities Exchange Act of 1934 and the Private Securities
Litigation Reform Act of 1995. In some cases, you can identify
forward-looking statements by terms such as, but not limited to,
“may,” “might,” “will,” “objective,” “intend,” “should,” "could,"
“can,” “would,” “expect,” “believe,” “anticipate,” “project,” “on
track,” “on schedule,” “target,” “design,” “estimate,” “predict,”
“potential,” “aim,” “plan,” or the negative of these terms, and
similar expressions intended to identify forward-looking
statements. Such forward-looking statements are based upon current
expectations that involve risks, changes in circumstances,
assumptions, and uncertainties. Aldeyra is at an early stage of
development and may not ever have any products that generate
significant revenue. All of Aldeyra's development timelines are
subject to adjustment depending on recruitment rate, regulatory
review, which regulatory review timeline may be flexible and
subject to change based on the regulator’s workload and other
potential review issues, preclinical and clinical results, funding,
and other factors that could delay the initiation, enrollment or
completion of clinical trials. Important factors that could cause
actual results to differ materially from those reflected in
Aldeyra's forward-looking statements include, among others,
Aldeyra’s plans to develop and commercialize product candidates, if
they are approved; delay in or failure to obtain regulatory
approval of Aldeyra's product candidates; the ability to maintain
regulatory approval of Aldeyra's product candidates, and the
labeling for any approved products; uncertainty as to Aldeyra’s
ability to commercialize (alone or with others) and obtain
reimbursement for Aldeyra's product candidates following regulatory
approval, if any; the size and growth of the potential markets and
pricing for Aldeyra's product candidates and the ability to serve
those markets; the rate and degree of market acceptance of any of
Aldeyra's product candidates; the rate and degree of market
acceptance of any of Aldeyra’s product candidates, following
regulatory approval, if any; the timing of enrollment, commencement
and completion of Aldeyra's clinical trials; the timing and success
of preclinical studies and clinical trials conducted by Aldeyra and
its development partners; the risk that prior results, such as
signals of safety, activity, or durability of effect, observed from
preclinical or clinical trials, will not be replicated or will not
continue in ongoing or future studies or clinical trials involving
Aldeyra's product candidates in clinical trials focused on the same
or on different indications; the scope, progress, expansion, and
costs of developing and commercializing Aldeyra's product
candidates; the current and potential future impact of the COVID-19
pandemic on Aldeyra’s business, results of operations and financial
position; Aldeyra's expectations regarding Aldeyra's expenses and
future revenue, the timing of future revenue, the sufficiency or
use of Aldeyra's cash resources and needs for additional financing;
Aldeyra's expectations regarding competition; Aldeyra's anticipated
growth strategies; Aldeyra's ability to attract or retain key
personnel; Aldeyra’s commercialization, marketing and manufacturing
capabilities and strategy; Aldeyra's ability to establish and
maintain development partnerships; Aldeyra’s ability to
successfully integrate acquisitions into its business; Aldeyra's
expectations regarding federal, state, and foreign regulatory
requirements; political, economic, legal, social, and health risks,
including the COVID-19 pandemic and subsequent public health
measures, and war or other military actions, that may affect
Aldeyra’s business or the global economy; regulatory developments
in the United States and foreign countries; Aldeyra's ability to
obtain and maintain intellectual property protection for its
product candidates; the anticipated trends and challenges in
Aldeyra's business and the market in which it operates; and other
factors that are described in the “Risk Factors” and “Management's
Discussion and Analysis of Financial Condition and Results of
Operations” sections of Aldeyra's Annual Report on Form 10-K for
the year ended December 31, 2021, and Aldeyra’s Quarterly Report on
Form 10-Q for the quarter ended September 30, 2022, which are on
file with the Securities and Exchange Commission (SEC) and
available on the SEC's website at https://www.sec.gov/. Additional
factors may be described in those sections of Aldeyra's Annual
Report on Form 10-K for the year ended December 31, 2022, expected
to be filed with the SEC in the first quarter of 2023.
In addition to the risks described above and in Aldeyra's other
filings with the SEC, other unknown or unpredictable factors also
could affect Aldeyra's results. No forward-looking statements can
be guaranteed, and actual results may differ materially from such
statements. The information in this release is provided only as of
the date of this release, and Aldeyra undertakes no obligation to
update any forward-looking statements contained in this release on
account of new information, future events, or otherwise, except as
required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20230301005873/en/
Investor & Media Contact: Scott Solomon Sharon
Merrill Associates, Inc. Tel: (857) 383-2409
ALDX@investorrelations.com
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