Clinical Trial Results and Potential New
Drug Application Resubmission Expected in the Second Half of
2024
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 completion of enrollment in
a Phase 3 dry eye chamber clinical trial of topical ocular 0.25%
reproxalap, an investigational RASP modulator, for the treatment of
dry eye disease. The trial is designed to enable potential
resubmission of a dry eye disease New Drug Application (NDA) in the
second half of 2024.
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In the clinical trial, a total of 132 patients were enrolled to
assess the primary endpoint of ocular discomfort. Initiation of
enrollment was announced in May 2024. In four previously completed
dry eye chamber clinical trials of reproxalap, when analyzed in
aggregate with the trial design and statistical plan discussed with
the U.S. Food and Drug Administration (FDA), ocular discomfort in
the dry eye chamber following treatment with reproxalap was
statistically lower than that of vehicle (p=0.0003).
“We believe the rapid enrollment of the Phase 3 clinical trial
is consistent with the unmet medical need that exists for patients
suffering from dry eye disease,” stated Todd C. Brady, M.D., Ph.D.,
President and Chief Executive Officer of Aldeyra. “We anticipate
receiving results from the clinical trial in the third quarter of
2024, and, contingent on positive results, we remain on track to
resubmit the dry eye disease NDA for reproxalap in the second half
of 2024.”
Aldeyra intends to include in the potential NDA resubmission a
draft label for reproxalap describing chronic and acute improvement
in symptoms and ocular redness. To Aldeyra’s knowledge, if
approved, the draft label could represent the first dry eye disease
label that incorporates clinical data assessed acutely in a dry eye
chamber, and potentially the first dry eye disease label that
includes reduction in ocular redness for a chronically administered
drug. Per FDA guidance, the review period for the potential NDA
resubmission is expected to be six months.
A Phase 3 clinical trial of reproxalap at a different dry eye
chamber, in addition to a traditional six-week field clinical
trial, are being conducted in parallel as part of a comprehensive
strategy designed to account for disease heterogeneity and
potential differences in clinical sites and environment.
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-246, ADX-248, and chemically
related molecules for the potential treatment of 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 expected timing and the results of Aldeyra’s
planned clinical trials, including planned and ongoing clinical
trials for reproxalap; the outcome and timing of the FDA’s review,
acceptance and/or approval of a NDA resubmission for reproxalap and
the adequacy of the data included in the original NDA and the
potential NDA resubmission; and Aldeyra’s expectations regarding
the labeling of 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 March
31, 2024, which are on file with the Securities and Exchange
Commission (SEC) and available on the SEC's website at
https://www.sec.gov/.
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/20240613335679/en/
Investor & Media: David Burke Tel: (917) 618-2651
investorrelations@aldeyra.com
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