LEXINGTON, Mass., Oct. 25, 2017 /PRNewswire/ -- Aldeyra
Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a clinical-stage
biotechnology company devoted to treating inflammation, inborn
errors of metabolism, and other diseases related to endogenous
aldehyde toxicity, today announced it will present data from the
previously announced Phase 2 clinical trial in noninfectious
anterior uveitis (NAU) demonstrating statistical non-inferiority of
ADX-102 to corticosteroid (Pred Forte®) monotherapy at the American
Uveitis Society Fall Meeting held in conjunction with the American
Academy of Ophthalmology 2017 Annual Meeting November 11 - 14 in New
Orleans, Louisiana.
NAU is a severe inflammatory disease that can cause blindness.
NAU is typically treated with corticosteroids, which are often
effective but can lead to serious ocular toxicities, including
glaucoma and cataracts.
Details of the presentation are as follows:
Title:
|
ADX-102 was
Non-inferior to Corticosteroid in a Randomized,
Comparator-Controlled Phase 2 Clinical Trial in Noninfectious
Anterior Uveitis
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|
|
Presenter:
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John Sheppard, M.D.,
Professor of Ophthalmology at Eastern Virginia Medical School and
President, Virginia Eye Consultants
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|
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Date:
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Sunday, November 12,
2017
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About Noninfectious Anterior
Uveitis
Noninfectious anterior uveitis is a rare,
potentially blinding disease that may be mediated in part by
pro-inflammatory aldehydes, and is characterized by inflammation in
the front of the eye, pain, impaired vision, and photophobia.
About Aldeyra Therapeutics
Aldeyra
Therapeutics, Inc. is a biotechnology company devoted to improving
lives by inventing, developing and commercializing products that
treat diseases thought to be related to endogenous aldehydes, a
naturally occurring class of pro-inflammatory and toxic
molecules. Aldeyra's lead product candidate, ADX-102, is an
aldehyde trap in development as topical eye drops for the treatment
of ocular inflammation. ADX-102 has now been tested in over 250
patients in Phase 2 clinical trials in dry eye disease, allergic
conjunctivitis, and noninfectious anterior uveitis. A dermatologic
form of ADX-102 is in late-stage clinical development for the
treatment of ichthyosis due to Sjögren-Larsson Syndrome, an inborn
error of aldehyde metabolism. ADX-102 has not been approved for
sale in the U.S. or elsewhere.
Safe Harbor Statement
This release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, including statements
regarding Aldeyra's plans and expectations for the development of
ADX-102 and the timing thereof; and the potential of ADX-102 as an
agent for the treatment of noninfectious anterior uveitis (NAU).
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 "may,"
"might," "will," "objective," "intend," "should," "could," "can,"
"would," "expect," "believe," "anticipate," "project," "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. 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, the ability to obtain and
maintain regulatory approval to conduct clinical trials and to
commercialize Aldeyra's product candidates, and the labeling for
any approved products; the scope, progress, expansion, and costs of
developing and commercializing Aldeyra's product candidates; the
size and growth of the potential markets for Aldeyra's product
candidates and the ability to serve those markets; Aldeyra's
expectations regarding Aldeyra's expenses and revenue, the
sufficiency 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 ability to
establish and maintain development partnerships; 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, 2016 and Quarterly Report on
Form 10-Q for the quarter ended June 30, 2017, which are on
file with the Securities and Exchange Commission (SEC) and
available on the SEC's website at www.sec.gov.
Additional factors may be described in those sections of Aldeyra's
Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, to be filed with the SEC in
the fourth quarter of 2017. 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.
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.
Corporate Contact:
Stephen Tulipano
Aldeyra Therapeutics, Inc.
Tel: +1 781-761-4904 ext. 205
stulipano@aldeyra.com
Investor Contact:
Chris Brinzey
Westwicke Partners
Tel: 339-970-2843
Chris.brinzey@westwicke.com
Media Contact:
Cammy Duong
MacDougall Biomedical Communications
781-591-3443
cduong@macbiocom.com
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SOURCE Aldeyra Therapeutics, Inc.