LEXINGTON, Mass., July 12, 2018 /PRNewswire/ -- Aldeyra
Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a biotechnology
company devoted to the development of next-generation medicines to
improve the lives of patients with immune-mediated diseases,
announced that the last patient has completed dosing in Aldeyra's
randomized, double-masked, vehicle-controlled, multi-center,
parallel-group Phase 2b clinical
trial of topical ocular reproxalap in dry eye disease.
"Dry eye disease, a persistently disturbing ocular inflammatory
condition, 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 of our Phase 2a dry eye disease clinical trial, as
well as our Phase 2 clinical successes in other ocular inflammatory
disorders, we are pleased to complete dosing in our Phase
2b dry eye disease trial, which is
designed to establish the drug concentration and patient group
sizes for Phase 3 testing. We look forward to providing the
top-line results from the trial later this year."
The Phase 2b clinical trial tested
two concentrations of topical ocular reproxalap (0.1% and 0.25%)
against vehicle over 12 weeks of treatment in 300 dry eye disease
patients. The primary objective of the trial is to select a drug
concentration for Phase 3 clinical testing, and to determine
appropriate patient numbers for Phase 3 clinical testing, based on
the activity of drug versus vehicle on standard dry eye disease
signs and symptoms.
In September 2017, Aldeyra
announced that the results of a randomized, double-masked,
parallel-group Phase 2a clinical trial of topical ocular reproxalap
demonstrated statistically and clinically relevant improvement from
baseline in multiple signs and symptoms associated with dry eye
disease. Improvement in symptoms was noted as soon as one week
following initiation of therapy. Tear RASP (pro-inflammatory
reactive aldehyde species) biomarkers diminished over the course of
treatment, and greater RASP reduction generally correlated with
clinical response.
Results from the Phase 2b trial
are expected to be announced in the second half of 2018.
About Aldeyra Therapeutics
Aldeyra
Therapeutics is developing 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 and other forms of
ocular inflammation. The company is also developing other product
candidates for autoimmune and metabolic diseases. None of Aldeyra's
product candidates have 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 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.
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 its other product candidates. 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, completion and reporting 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, 2017 and Aldeyra's Quarterly
Report on Form 10-Q for the quarter ended March 31, 2018, both of 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 set forth in those sections of Aldeyra's Quarterly
Report on Form 10-Q for the quarter ended June 30, 2018, to be filed with the SEC in the
third 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, completion or
reporting 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:
David McMullin
Aldeyra Therapeutics, Inc.
Tel: 781-761-4904 ext. 218
dmcmullin@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.