LEXINGTON, Mass., Nov. 29, 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, presented new statistical analyses of the
results of a randomized, multi-center, investigator-masked,
comparator-controlled, parallel-group Phase 2 clinical trial of
topical ocular reproxalap (formerly known as ADX-102), a
first-in-class aldehyde sequestering agent, to the American Uveitis
Society held at the American Academy of Ophthalmology 2017 Annual
Meeting. The results of the analyses demonstrated formal
statistical non-inferiority (p=0.036 after two weeks of therapy,
p=0.048 after four weeks of therapy) of 0.5% reproxalap ophthalmic
solution to Pred Forte®, a topical ocular corticosteroid, in
reducing anterior chamber inflammatory cell count, the standard
noninfectious anterior uveitis clinical endpoint. The combination
of reproxalap and low-frequency (twice-daily) Pred Forte®
administration was also statistically non-inferior to Pred Forte®
monotherapy (four-times-daily). Dr. John
Sheppard, an internationally recognized expert in ocular
inflammation, gave the presentation, which is available on the
investor relations page of the Aldeyra Therapeutics corporate
website at ir.aldeyra.com.
"The use of corticosteroid therapy for the treatment of ocular
inflammation is hampered by ophthalmic toxicity, including cataract
formation, secondary infection, viral reactivation, delayed wound
healing and elevated intraocular pressure that can cause
irreversible glaucomatous optic atrophy," commented Dr.
Sheppard. "Reproxalap could represent a welcome addition to
the topical therapeutic options available to practitioners who
treat noninfectious anterior uveitis, a severe inflammatory disease
which can lead to permanent vision loss."
In April 2017, Aldeyra announced
the initiation of a Phase 3 clinical trial of topical reproxalap in
patients with noninfectious anterior uveitis. The Phase 3 trial is
expected to enroll up to 100 patients with active disease,
randomized equally to receive either 0.5% topical ocular reproxalap
or vehicle for four weeks. Consistent with prior clinical
trials used for marketing registration, the primary endpoint will
be the resolution of anterior chamber cellular inflammation.
Results of the trial are expected to be announced in the second
half of 2018.
Pro-inflammatory aldehyde mediators are a novel target in the
treatment of inflammation. The positive clinical results reported
for reproxalap from Phase 2 clinical trials in dry eye disease,
allergic conjunctivitis, and noninfectious anterior uveitis suggest
that aldehyde sequestration could also be effective for the
treatment of inflammatory diseases that affect other parts of the
body, including systemic inflammatory and autoimmune conditions
that afflict millions of patients worldwide.
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, 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 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.
Topical corticosteroid therapy is the only approved therapy for the
resolution of inflammation associated with noninfectious anterior
uveitis, but can lead to serious ocular complications, including
glaucoma, infections, and cataracts.
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 ADX-103; and the potential of Reproxalap as an agent
for the treatment of noninfectious anterior uveitis, dry eye
disease and allergic conjunctivitis and ADX-103 as an agent for the
treatment of retinal 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. 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: 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
Tel: 781-591-3443
cduong@macbiocom.com
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SOURCE Aldeyra Therapeutics, Inc.