Aldeyra Therapeutics Announces Results from the SOLACE Trial in Noninfectious Anterior Uveitis
June 25 2019 - 7:00AM
Business Wire
- Statistical Significance Not Achieved for Primary or Secondary
Endpoints Due to High Rates of Disease Resolution in
Vehicle-Treated Patients, but Activity of Reproxalap Observed to be
Consistently Greater than Vehicle
- Noninfectious Anterior Uveitis Program to be Discontinued
- Company Plans to Prioritize Phase 3 Ocular Pipeline Programs in
Dry Eye Disease, Allergic Conjunctivitis, and Proliferative
Vitreoretinopathy
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 results from the
noninfectious anterior uveitis SOLACE Trial. Statistical
significance was not achieved for the primary or secondary
endpoints, due to high rates of disease resolution in
vehicle-treated patients, but activity of reproxalap was
consistently greater than that of vehicle.
“The results of the SOLACE Trial confirm the potential of
reproxalap to treat ocular inflammation, and further validate the
novel mechanism of action of reproxalap, which demonstrated highly
statistically significant immune-modulating activity in the Phase 3
ALLEVIATE Trial and Phase 2b Dry Eye Disease trial,” stated Todd C.
Brady, M.D., Ph.D., President and Chief Executive Officer of
Aldeyra. “We look forward to aggressively prioritizing advancement
of high-value ocular programs in dry eye disease, allergic
conjunctivitis, and proliferative vitreoretinopathy.”
Topical ocular reproxalap was observed to be safe and
well-tolerated. Reproxalap ophthalmic solution, in various
concentrations, has now been administered to over 800 patients in
nine clinical trials for ocular inflammation.
Conference Call Aldeyra will hold a conference call on
June 25, 2019 at 8:00 a.m. Eastern Time. The dial-in numbers are
(866) 211-4098 for domestic callers and (647) 689-6613 for
international callers. The Conference ID is 8856138. A live,
listen-only audio webcast of the conference call can be accessed on
the investor relations page of Aldeyra's corporate website at
ir.aldeyra.com. After the live webcast, the event will remain
archived on the Aldeyra Therapeutics website for thirty days.
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 candidates are
first-in-class 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.
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 and
Aldeyra's Quarterly Report on Form 10-Q for the quarter ended March
31, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190625005508/en/
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
Media Contact: Sean Leous Westwicke, an ICR Company Tel:
646-677-1839 Sean.leous@icrinc.com
Aldeyra Therapeutics (NASDAQ:ALDX)
Historical Stock Chart
From Apr 2024 to May 2024
Aldeyra Therapeutics (NASDAQ:ALDX)
Historical Stock Chart
From May 2023 to May 2024