Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today
announced that an oral presentation highlighting clinical data from
the Phase 3 INVIGORATE allergen chamber trial of reproxalap in
allergic conjunctivitis will be presented at the American Academy
of Optometry 2022 Annual Meeting, taking place in San Diego October
26-29, 2022.
Oral Presentation Abstract Title: Clinically Relevant
Activity of Reproxalap in an Allergen Chamber Model of Allergic
Conjunctivitis: The Phase 3 INVIGORATE Trial Presenter: Jacob R.
Lang, O.D., F.A.A.O., Medical Director of Dry Eye Services,
Associated Eye Care, St. Paul, Minnesota Date: Wednesday, October
26, 2022 Location: Room 29AB
“Reproxalap demonstrated statistically significant and
clinically relevant reductions relative to vehicle in ocular
itching and redness in the INVIGORATE Trial,” Dr. Lang stated.
“Given the strong overlap between allergic conjunctivitis and dry
eye disease, the findings being presented at the Academy’s Annual
Meeting further highlight the potential benefits of Aldeyra’s novel
RASP modulator to improve treatment outcomes for patients with
anterior segment inflammation.”
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 Allergic Conjunctivitis Allergic conjunctivitis is
the most common inflammatory disease that affects the front of the
eye, and is characterized by itching, redness, and tearing.1 The
signs and symptoms of allergic conjunctivitis are persistently
disturbing, affecting quality of life and leading to loss of work
that can create a substantial economic burden for patients and
their families.2 Although allergic conjunctivitis is commonly
treated with antihistamines, up to 60% of patients require
adjunctive therapy and up to 40% of patients require
corticosteroids, which can lead to significant ocular
toxicity.3
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 (methotrexate injection) for intravitreal administration,
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 the potential benefits of
reproxalap in improving treatment outcomes for patients with
anterior segment inflammation. 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 The American Academy of Allergy, Asthma & Immunology
(AAAAI), Allergic Conjunctivitis Defined 2 Andrew D. Pitt, Andrew
F. Smith, Lynda Lindsell, Li Wern Voon, Peter W. Rose & Anthony
J. Bron (2004) Economic and quality-of-life impact of seasonal
allergic conjunctivitis in Oxfordshire, Ophthalmic Epidemiology,
11:1, 17-33, doi: 10.1076/opep.11.1.17.26437 3 Leonardi A, Piliego
F, Castegnaro A, et al. Allergic conjunctivitis: a cross-sectional
study. Clin Exp Allergy. 2015;45(6):1118–1125.
doi:10.1111/cea.12536
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Investor & Media Contact: Scott Solomon Sharon
Merrill Associates, Inc. Tel: (857) 383-2409
ALDX@investorrelations.com
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