LEXINGTON, Mass., Jan. 30, 2018 /PRNewswire/ -- Aldeyra
Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a clinical-stage
biotechnology company devoted to treating inflammation and inborn
errors of metabolism, today announced that it has enrolled the
first patient in a Phase 2b clinical
trial of topical ocular reproxalap for the treatment of dry eye
disease (DED).
"Existing therapy for dry eye disease, a common inflammatory
condition that leads to persistently disturbing ocular irritation,
is generally considered by physicians and patients to be
inadequate, but represents one of the largest ophthalmic markets
worldwide," commented Todd C. Brady,
M.D., Ph.D., President and CEO of Aldeyra. "Based on the
positive results from the Phase 2a dry eye disease clinical trial
with our topical ocular product candidate reproxalap announced in
September 2017, we are pleased to
begin enrolling our Phase 2b clinical
trial, and expect to report results in the second half of this
year."
Reproxalap and other product candidates generated from Aldeyra's
aldehyde trap platform sequester and facilitate the degradation of
pro-inflammatory aldehyde mediators, a class of small molecule
therapeutic targets that are elevated in DED patients. The Phase
2b clinical trial will test two
concentrations of topical reproxalap (0.1% and 0.25%) against
vehicle over 12 weeks of treatment in 300 patients with moderate
dry eye disease. Consistent with the Phase 2a clinical trial,
endpoints will include standard signs and symptoms characteristic
of DED.
A clinical trial synopsis can be found on clinicaltrials.gov
(#NCT03404115).
About Aldeyra
Therapeutics
Aldeyra Therapeutics, Inc. is a
biotechnology company devoted to improving lives by inventing,
developing, and commercializing products that treat inflammation
and inborn errors of metabolism. Aldeyra's lead product
candidate, reproxalap (formerly known as ADX-102), is a small
molecule aldehyde sequestering agent in Phase 2b clinical development for the treatment of dry
eye disease, and Phase 3 clinical development for the treatment of
allergic conjunctivitis, noninfectious anterior uveitis, and
Sjögren-Larsson Syndrome. Reproxalap has not been approved for sale
in the U.S. or elsewhere.
About Dry Eye Disease
Dry eye disease is a
common and chronic inflammatory disease estimated to affect
approximately 20 million people in the
United States, and is characterized by insufficient moisture
and lubrication in the anterior surface of the eye, leading to
dryness, inflammation, pain, discomfort, irritation, and, in severe
cases, decreased vision. Among physicians and patients, existing
therapy for dry eye disease is generally regarded as inadequate. In
patients with dry eye disease, pro-inflammatory aldehyde mediators
may contribute to ocular inflammation. By diminishing aldehyde
levels, Aldeyra's topical ocular aldehyde trap platform represents
a novel and differentiated approach for the treatment of dry eye
disease.
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
reproxalap; and the potential of reproxalap as an agent for the
treatment of dry eye disease. 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 September 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 Annual Report on Form 10-K for the
year ended December 31, 2017,
expected to be filed with the SEC in the first quarter of 2018.
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.