Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today
announced that it will host an ePoster presentation and discussion
of the company’s ALLEVIATE Phase 3 clinical trial of reproxalap in
patients with allergic conjunctivitis at the American Academy of
Ophthalmology 2019 Annual Meeting, which takes place October 12-15,
2019 at the Moscone Center in San Francisco, California.
In the ALLEVIATE trial, 318 patients were topically challenged
with seasonal allergen and randomized to 0.25% or 0.5% reproxalap
topical ophthalmic solution, or vehicle ophthalmic solution. The
trial achieved the primary endpoint of reduction in
patient-reported ocular itching relative to vehicle, as assessed by
area under the ocular itch score curve. Two-point responder rates
and rates of complete resolution of itch in patients treated with
0.25% and 0.5% reproxalap were statistically greater than that of
vehicle-treated patients, confirming the clinical relevance of the
improvement of drug over vehicle in the primary endpoint.
Topical ocular reproxalap, a novel Reactive Aldehyde Species
(RASP) inhibitor, has been administered to over 800 patients across
ten completed clinical trials with no observed safety or
tolerability concerns. In June 2019, Aldeyra announced results of
topical ocular reproxalap in an allergen chamber trial, which
demonstrated that ocular itching and redness in reproxalap-treated
patients were statistically lower than that of vehicle-treated
patients.
“The immune-modulating profile exhibited by both concentrations
of reproxalap is distinct from standard-of-care antihistamine
therapy,” said Todd Brady, M.D., Ph.D., President and CEO of
Aldeyra. “Reproxalap represents a fundamentally different mechanism
of action that we believe has the potential to be the first new
approach in allergic conjunctivitis in more than 40 years.”
Aldeyra plans to initiate a second Phase 3 trial of topical
ocular reproxalap in patients with allergic conjunctivitis
following feedback from the U.S. Food and Drug Administration,
which is expected in the fourth quarter of this year.
Poster presentation details:
Title:
The ALLEVIATE Phase 3 Allergic
Conjunctivitis Clinical Trial of Topical Ocular Reproxalap, a Novel
RASP Inhibitor
Session:
PD45 Cornea, External Disease ePoster
Discussion
Date/Time:
Monday, October 14, 2019, 1:15 PM to 1:45
PM (PT)
Location:
ePoster Lounge, Station 3
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 investigational drug
product candidates are first-in-class potential treatments in
development for dry eye disease, allergic conjunctivitis,
proliferative vitreoretinopathy, and Sj�gren-Larsson Syndrome. The
company is also developing other product candidates for retinal and
systemic inflammatory diseases.
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 relating to current or future clinical
development. 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, but not limited to, "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 and
Aldeyra's Quarterly Report on Form 10-Q for the quarter ended June
30, 2019, which are on file with the Securities and Exchange
Commission (SEC) and available on the SEC's website at
www.sec.gov.
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.
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Corporate Contact: David McMullin Aldeyra Therapeutics,
Inc. Tel: 781-761-4904 ext. 218 dmcmullin@aldeyra.com
Investor & Media Contact: Scott Solomon Sharon
Merrill Associates, Inc. Tel: 617-542-5300
ALDX@investorrelations.com
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