PDUFA Date is November 23, 2023
First-in-Class RASP Modulator Represents a
Potential New Therapeutic Paradigm for Patients Suffering from Dry
Eye Disease
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today
announced that the U.S. Food and Drug Administration (FDA) has
accepted the New Drug Application (NDA) for topical ocular
reproxalap, a first-in-class investigational new drug candidate,
for the treatment of the signs and symptoms of dry eye disease. The
FDA assigned a Prescription Drug User Fee Act (PDUFA) date of
November 23, 2023. The FDA noted that no potential filing review
issues have been identified, and that an advisory committee meeting
is not currently planned.
“NDA acceptance marks a critical regulatory milestone for
Aldeyra as reproxalap continues to advance toward potential
regulatory approval for the treatment of dry eye disease,” stated
Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer
of Aldeyra. “Based on data from a number of late-stage clinical
trials, we believe reproxalap has the potential to address the need
for a rapid and durable ophthalmic therapy for the millions of dry
eye disease patients who are dissatisfied with currently available
therapies.”
The NDA is supported by previously announced safety and efficacy
results from five adequate and well-controlled clinical trials
encompassing data for ocular dryness symptom score, ocular redness,
Schirmer test, and Schirmer test ≥10 mm responder analysis. The NDA
includes activity ranging from within minutes of drug
administration to up to 12 weeks of treatment, crossover and
parallel-group clinical trial designs, and assessment in dry eye
chamber challenge and natural environment settings. Topical ocular
reproxalap has been studied in more than 2,000 patients with no
observed clinically significant safety concerns; mild and transient
instillation site irritation is the most commonly reported adverse
event in clinical trials.
About Reproxalap
Reproxalap, an investigational new drug candidate, is a
first-in-class small-molecule modulator of RASP (reactive aldehyde
species), which are elevated in ocular and systemic inflammatory
disease. 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.
About Dry Eye Disease
Dry eye disease is a common inflammatory disease estimated to
affect 39 million or more adults in the United States.1 The disease
is characterized by insufficient moisture and lubrication in the
anterior surface of the eye, leading to dryness, inflammation,
pain, discomfort, irritation, diminished quality of life, and in
severe cases, permanent vision impairment. Among many physicians
and patients, existing therapy for dry eye disease is generally
regarded as inadequate and often requires weeks or months to
demonstrate activity. In patients with dry eye disease, RASP may
contribute to ocular inflammation, diminished tear production,
ocular redness, and changes in tear lipid composition.2 By
diminishing RASP levels, Aldeyra’s lead RASP modulator reproxalap
represents a novel and differentiated approach for the treatment of
the symptoms and signs of dry eye disease.
About Aldeyra
Aldeyra Therapeutics is a clinical-stage biotechnology company
developing innovative therapies designed to treat immune-mediated
diseases. Our approach is to discover 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 pre-commercial
product candidates are reproxalap, a potential treatment for dry
eye disease and allergic conjunctivitis, and ADX-2191, a potential
treatment for primary vitreoretinal lymphoma, proliferative
vitreoretinopathy, and retinitis pigmentosa. In addition, we are
developing other product candidates, including ADX-629 and
chemically related molecules, for the potential treatment of
systemic and retinal immune-mediated 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 reproxalap by the PDUFA date of November 23, 2023, or at any
other time and the potential profile, the expectation around any
potential future request by the FDA to hold an advisory committee
meeting related to the NDA, benefit and market size of reproxalap
in dry eye disease should the NDA for reproxalap 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.
______________________________ 1 Company estimates and Paulsen
AJ, Cruickshanks KJ, Fischer ME, et al. Dry eye in the beaver dam
offspring study: prevalence, risk factors, and health-related
quality of life. Am J Ophthalmol. 2014;157(4):799-806. 2 Choi W,
Lian C, Ying L, Kim GE, You IC, Park SH, Yoon KC. Expression of
Lipid Peroxidation Markers in the Tear Film and Ocular Surface of
Patients with Non-Sjogren Syndrome: Potential Biomarkers for Dry
Eye Disease. Curr Eye Res. 2016 Sep;41(9):1143-9. doi:
10.3109/02713683.2015.1098707. Epub 2016 Jan 5. PMID: 26731289.
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Investor & Media Contact: Scott Solomon Sharon
Merrill Associates, Inc. Tel: (857) 383-2409
ALDX@investorrelations.com
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