Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a
biotechnology company devoted to discovering and developing
innovative therapies designed to treat immune-mediated and
metabolic diseases, today announced the resubmission of a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA)
for topical ocular reproxalap, an investigational new drug
candidate, for the treatment of signs and symptoms of dry eye
disease. The resubmission includes previously disclosed positive
results from a recently completed dry eye disease symptom trial
requested by the FDA following review of the previously submitted
NDA, as well as a draft label reflecting acute activity in reducing
dry eye symptoms in a dry eye chamber trial, chronic activity in
reducing dry eye symptoms in a field trial, and acute activity in
reducing ocular redness in two dry eye chamber trials.
“If approved, reproxalap would have the potential to be the
first dry eye disease therapy for chronic use with pivotal data
demonstrating acute activity in reducing dry eye symptoms and
ocular redness, two characteristics of dry eye disease of primary
importance to patients,” stated Todd C. Brady, M.D., Ph.D.,
Aldeyra’s President and Chief Executive Officer.
In August 2024, Aldeyra announced the achievement of the primary
endpoint in a Phase 3 randomized, double-masked, vehicle-controlled
dry eye chamber clinical trial of reproxalap in patients with dry
eye disease. Reproxalap was statistically superior to vehicle for
the prespecified primary endpoint of ocular discomfort (P=0.004),
an FDA-accepted symptom of dry eye disease. To Aldeyra’s knowledge,
the results represented the first positive Phase 3 clinical trial
in a dry eye chamber with a symptom as a primary endpoint, and
Aldeyra believes that results are supportive of the potential rapid
clinical effect of reproxalap on reducing the ocular discomfort
associated with dry eye disease.
The Prescription Drug User Fee Act target guidelines for NDA
resubmissions include acknowledgment of acceptance for review
within 30 days of submission, and completion of submission review
within 6 months.
About Reproxalap
Reproxalap is an investigational new drug candidate in
development for the treatment of dry eye disease and allergic
conjunctivitis, two of the largest markets in ophthalmology.
Reproxalap is a first-in-class small-molecule modulator of RASP,
which are elevated in ocular and systemic inflammatory diseases.
The mechanism of action of reproxalap has been supported by the
demonstration of statistically significant and clinically relevant
activity in multiple physiologically distinct late-phase clinical
indications. Reproxalap has been studied in more than 2,500
patients with no observed safety concerns; mild and transient
instillation site irritation is the most commonly reported adverse
event in clinical trials.
About Aldeyra
Aldeyra Therapeutics is a biotechnology company devoted to
discovering innovative therapies designed to treat immune-mediated
and metabolic diseases. Our approach is to develop pharmaceuticals
that modulate protein 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-248, ADX-743, ADX-631, and chemically related
molecules for the potential treatment of systemic and retinal
immune-mediated and metabolic diseases. Our late-stage product
candidates are reproxalap, a RASP modulator for the potential
treatment of dry eye disease and allergic conjunctivitis, and
ADX-2191, a novel formulation of intravitreal methotrexate for the
potential treatment of retinitis pigmentosa.
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 regarding Aldeyra’s
future expectations, plans, and prospects, including without
limitation statements regarding: the goals, opportunity, and
potential for reproxalap; the outcome and timing of the FDA’s
review, acceptance and/or approval of the NDA resubmission for
reproxalap and the adequacy of the data included in the previously
submitted NDA and the NDA resubmission; and Aldeyra’s expectations
regarding the labeling for reproxalap, if approved. 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,” “scheduled,” “target,” “design,” “estimate,” “predict,”
“contemplates,” “likely,” “potential,” “continue,” “ongoing,”
“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 may be subject to adjustment
depending on recruitment rate, regulatory review, 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, 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; delay in or failure to obtain regulatory
approval of Aldeyra's product candidates, including as a result of
the FDA not accepting Aldeyra’s regulatory filings, issuing a
complete response letter, or requiring additional clinical trials
or data prior to review or approval of such filings or in
connection with resubmissions of such filings; the ability to
maintain regulatory approval of Aldeyra's product candidates, and
the labeling for any approved products; 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 different indications; the scope,
progress, expansion, and costs of developing and commercializing
Aldeyra's product candidates; 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; 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;
the rate and degree of market acceptance of any of Aldeyra's
product candidates; 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, 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, 2023, and
Aldeyra’s Quarterly Report on Form 10-Q for the quarter ended June
30, 2024, 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 Quarterly Report on Form 10-Q for the quarter
ended September 30, 2024, expected to be filed with the SEC in the
fourth quarter of 2024.
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/20241003572695/en/
Investor & Media Contact: David Burke Tel: (917) 618-2651
investorrelations@aldeyra.com
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