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:
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Title:
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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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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.