Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a
biotechnology company discovering and developing innovative
therapies for the treatment of immune-mediated diseases, today
announced completion of enrollment in Part 1 of the Phase 3 GUARD
Trial of ADX-2191 (intravitreal methotrexate 0.8%) in patients with
proliferative vitreoretinopathy (PVR), a rare, sight-threatening
ocular disease with no approved therapy.
The GUARD Trial is a two-part, multi-center, randomized,
parallel-group, adaptive Phase 3 clinical trial evaluating the
efficacy of intravitreal injections of ADX-2191 versus standard of
care (routine monitoring) for the prevention of PVR following
retinal detachment repair. The primary endpoint is recurrent
retinal detachment rates over a 24-week post-operative period. Part
1 of the GUARD Trial, which enrolled 110 patients, is being
conducted in the United States. Top-line results from Part 1 are
expected in the second half of 2022.
“ADX-2191 has the potential to become the first drug in the U.S.
indicated for the prevention of PVR, a sight-threatening condition
for which there is no approved treatment,” stated Todd C. Brady,
M.D., Ph.D., President and Chief Executive Officer of Aldeyra.
“Clinical results suggest that methotrexate, the active ingredient
of ADX-2191, may diminish the rates of retinal detachment and
improve visual outcomes in thousands of patients who undergo
surgery for PVR.”
ADX-2191, a vitreous-compatible formulation of methotrexate, has
been granted fast track and orphan drug designation by the U.S.
Food and Drug Administration for the prevention of PVR. Fast track
designation is designed to facilitate the development and expedite
the review of drugs that treat serious conditions, potentially
accelerating patient access to new therapies. Orphan drug
designation qualifies sponsors for incentives including tax credits
for qualified clinical trials; exemption from user fees; and market
exclusivity after approval, if received.
About Aldeyra Therapeutics
Aldeyra Therapeutics discovers and develops innovative therapies
designed to treat immune-mediated diseases. Our approach is to
develop therapies designed to modulate immunological systems,
without inhibiting or activating single 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 Phase 3 clinical
trials in patients with dry eye disease and allergic
conjunctivitis. ADX-629, an orally administered RASP modulator, is
in Phase 2 proof-of-concept clinical trials in psoriasis, atopic
asthma, and COVID-19. Our clinical pipeline also includes ADX-2191
(intravitreal methotrexate 0.8%), in Phase 3 clinical testing for
the prevention of proliferative vitreoretinopathy. 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
strategy, future operations, prospects, plans, and objectives and
Aldeyra's plans and expectations for its product candidates,
including ADX-2191. 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," "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 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 review and
quality control analysis of clinical data, Aldeyra's ability to
design clinical trials with protocols 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) 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 related public health
measures, 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, 2020 and Quarterly Report on Form 10-Q for the quarter ended
September 30, 2021, 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, 2021, expected to be filed with the SEC in the first
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220103005519/en/
Corporate Contact: Joshua Reed Aldeyra Therapeutics, Inc.
Tel: 781-761-4904 ext. 218 jreed@aldeyra.com
Investor & Media Contact: Scott Solomon Sharon
Merrill Associates, Inc. Tel: 617-542-5300
ALDX@investorrelations.com
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