LEXINGTON, Mass., April 30, 2019 /PRNewswire/ -- Aldeyra
Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology
company devoted to developing and commercializing next-generation
medicines to improve the lives of patients with immune-mediated
diseases, today announced that the last patient has completed
dosing in the SOLACE Phase 3 clinical trial of topical ocular
reproxalap in patients with noninfectious anterior uveitis.
"We look forward to announcing the results of the SOLACE trial,
our second Phase 3 clinical trial to complete this year," stated
Todd C. Brady, M.D., Ph.D.,
President and CEO of Aldeyra. "Noninfectious anterior uveitis is a
rare but severe inflammatory ocular disease characterized by pain,
photophobia, and, in some cases, vision loss. An estimated 50% of
patients suffer from recurrent or chronic episodes, increasing the
risk of serious ocular toxicity caused by prolonged exposure to
corticosteroids, the current standard of care. As a first-in-class
novel compound with a unique product profile, reproxalap has the
potential to treat patients without the toxicities commonly
associated with corticosteroids."
The SOLACE trial is a randomized, multi-center, double-masked,
parallel-group, vehicle-controlled Phase 3 clinical trial of 0.5%
topical ocular reproxalap in patients with noninfectious anterior
uveitis. The primary outcome measure is time-to-cure without rescue
therapy.
Results from the SOLACE trial are expected to be announced in
the second half of 2019.
About Noninfectious Anterior
Uveitis
Noninfectious anterior uveitis is a rare,
potentially blinding disease characterized by inflammation in the
front of the eye, pain, impaired vision, and photophobia. Topical
corticosteroids are the only approved therapies for resolution of
inflammation associated with noninfectious anterior uveitis, but
can lead to serious ocular complications, including glaucoma,
infection, and cataract formation.
About Aldeyra
Therapeutics
Aldeyra Therapeutics is a biotechnology
company devoted to developing and commercializing next-generation
medicines to improve the lives of patients with immune-mediated
diseases. Aldeyra's lead product candidate, reproxalap, is a
first-in-class treatment in late-stage development for dry eye
disease, allergic conjunctivitis, noninfectious anterior uveitis,
and Sjögren-Larsson Syndrome. The company is also developing other
product candidates for proliferative vitreoretinopathy and other
retinal diseases, post-transplant lymphoproliferative disease,
autoimmune disease, metabolic disease, and cancer. None of
Aldeyra's product candidates have 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 strategy, future operations, future financial
position, projected costs and expenses, prospects, plans, and
objectives and Aldeyra's plans and expectations for its product
candidates, including plans to initiate further clinical testing,
the timing of results from clinical programs, and its regulatory
plans. 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. 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
trials involving Aldeyra's product candidates; 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; 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, 2018
which is 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 March 31, 2019, to be filed with the SEC in the
second quarter of 2019.
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:
David
McMullin
Aldeyra Therapeutics, Inc.
Tel: 781-761-4904 ext. 218
dmcmullin@aldeyra.com
Investor Contact:
Chris
Brinzey
Westwicke, an ICR Company
Tel: 339-970-2843
Chris.brinzey@westwicke.com
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SOURCE Aldeyra Therapeutics, Inc.