Dry Eye Disease NDA for Reproxalap Expected
to be Submitted in the Fourth Quarter of 2022
Pre-NDA Meeting for ADX-2191 for the
Treatment of Primary Vitreoretinal Lymphoma Scheduled for the
Fourth Quarter of 2022
Results from Part 1 of the Phase 3 GUARD
Trial of ADX-2191 in Proliferative Vitreoretinopathy Expected in
the Third or Fourth Quarter of 2022
Results from the Phase 2 Clinical Trial of
ADX-2191 in Retinitis Pigmentosa Expected in the First Half of
2023
Results from the Phase 3 INVIGORATE-2 Trial
of Reproxalap in Allergic Conjunctivitis Expected in 2023
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today
announced that, following the recent receipt of official minutes
from its pre-NDA (New Drug Application) meeting with the U.S. Food
and Drug Administration (FDA), the Company remains on schedule to
submit an NDA in the fourth quarter of 2022 requesting marketing
approval of the novel RASP modulator reproxalap, an investigational
new drug, for the treatment of dry eye disease.
“Based on the outcome of our pre-NDA meeting, we believe that we
have aligned with the FDA on the content of the regulatory package
that will support what we expect to be a uniquely comprehensive NDA
submission for the treatment of dry eye disease, encompassing data
demonstrating improvement that may occur within minutes of drug
administration in symptoms and three different objective signs,”
stated Todd C. Brady, M.D., Ph.D., Aldeyra’s President and Chief
Executive Officer. “In contrast to currently available dry eye
therapies that may require weeks of administration to achieve even
modest benefit, the rapid onset of activity of reproxalap observed
in clinical trials represents a potential paradigm shift in the
treatment of dry eye disease.”
Consistent with prior guidance, with results from five adequate
and well-controlled completed clinical trials, Aldeyra intends to
submit the NDA with data for ocular dryness symptom score, ocular
redness, Schirmer test, and Schirmer test ≥10 mm responder
analysis. The NDA efficacy package is expected to include 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. In addition to efficacy data, Aldeyra plans
to submit up to 12 months of safety data. Topical ocular reproxalap
has been studied in more than 2,000 patients with no observed
safety concerns; mild and transient instillation site irritation is
the most commonly reported adverse event in clinical trials.
In addition to the planned NDA submission for reproxalap in dry
eye disease, Aldeyra highlighted the following expected upcoming
corporate milestones:
- The pre-NDA meeting for ADX-2191 for the treatment of primary
vitreoretinal lymphoma has been scheduled for the fourth quarter of
2022.
- Results from Part 1 of the Phase 3 GUARD trial of ADX-2191 in
proliferative vitreoretinopathy are expected in the third or fourth
quarter of 2022.
- Results from the Phase 2 clinical trial of ADX-2191 in
retinitis pigmentosa are expected in the first half of 2023.
- Results from the Phase 3 INVIGORATE-2 trial of reproxalap in
allergic conjunctivitis are expected in 2023.
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. Reproxalap’s mechanism of action 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 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. Two of our lead product
candidates, reproxalap and ADX-629, target pre-cytokine,
systems-based mediators of inflammation known as RASP (reactive
aldehyde species). Reproxalap is in late-stage clinical trials in
patients with dry eye disease and allergic conjunctivitis. ADX-629,
an orally administered RASP modulator, is in Phase 2 clinical
testing for the treatment of systemic immune-mediated diseases. Our
pipeline also includes ADX-2191 (intravitreal methotrexate 0.8%),
in development for the prevention of proliferative
vitreoretinopathy and the treatment of retinitis pigmentosa and
primary vitreoretinal lymphoma. 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 regarding Aldeyra's
future expectations, plans and prospects, including without
limitation statements regarding: plans for an NDA filing for
reproxalap for the treatment of dry eye disease, and the potential
timing of such submission; Aldeyra’s belief in the adequacy of the
data it plans to submit in the NDA; the potential for FDA
acceptance of an NDA for reproxalap; the potential for regulatory
approval and commencement of commercialization of reproxalap and
Aldeyra’s goals as to timing; the potential profile and benefit of
reproxalap in dry eye disease; anticipated clinical or regulatory
milestones for ADX-2191, including expectations regarding the
results of scheduled pre-NDA meetings and clinical trials; and
other statements regarding the goals, opportunity and potential for
reproxalap and ADX-2191, and for Aldeyra’s business. 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 may be subject to adjustment depending on
recruitment rate, regulatory review, preclinical and clinical
results, 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; updated or refined data based on Aldeyra's
continuing or post-hoc review and quality control analysis of
clinical data, Aldeyra's ability to design clinical trials with
protocols, data analysis methodologies, and endpoints acceptable to
applicable regulatory authorities; 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; 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 risk
that the results from earlier clinical trials, portions of clinical
trials, or pooled clinical data may not accurately predict results
of subsequent trials or the remainder of a clinical trial; 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 revenue, the sufficiency or use of Aldeyra's
cash resources and needs for additional financing; 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; 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 limited sales
and marketing infrastructure; 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; 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 June 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 set forth in those
sections of Aldeyra's Quarterly Report on Form 10-Q for the quarter
ended September 30, 2022, expected to be filed with the SEC in the
fourth quarter of 2022.
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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Investors & Media: Scott Solomon Sharon Merrill
Associates, Inc. (857) 383-2409 ALDX@investorrelations.com
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