LEXINGTON, Mass., April 24, 2018 /PRNewswire/ -- Aldeyra
Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a biotechnology company devoted to development of next-generation medicines to
improve the lives of patients with inflammatory diseases, today announced that it has enrolled the first patient in a Phase 3
clinical trial of topical ocular reproxalap for the treatment of allergic conjunctivitis.
"We are pleased to advance our allergic conjunctivitis program to Phase 3 clinical testing," commented Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. "With clinically demonstrated post-histaminic
activity, reproxalap could represent the first mechanistically differentiated product in decades for the treatment of allergic
conjunctivitis, a chronic disease that affects approximately 100 million patients in the United
States. We look forward to presenting the results of the trial in the second half of 2018 or early 2019."
The multi-center, double-masked, parallel-group, vehicle-controlled Phase 3 clinical trial is expected to enroll 300 allergic
conjunctivitis patients, randomized equally to receive either topical ocular 0.25% reproxalap, 0.5% reproxalap, or vehicle in a
conjunctival allergen challenge model of acute allergic conjunctivitis. The primary outcome measure will be
patient-reported ocular itching.
A clinical trial synopsis can be found on clinicaltrials.gov (#NCT03494504).
About Aldeyra Therapeutics
Aldeyra Therapeutics is developing next-generation medicines to improve the lives of patients with inflammatory
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. Aldeyra is leveraging its experience in ocular inflammation to develop other
product candidates for systemic inflammatory disease. None of Aldeyra's product candidates have been approved for sale in
the U.S. or elsewhere.
About Allergic Conjunctivitis
Allergic conjunctivitis is a common allergic disease that affects 20% or more of the population worldwide. The
disease is characterized by inflammation of the conjunctiva (a membrane covering part of the front of the eye), resulting in
ocular itching, excessive tear production, lid swelling, and redness. Antihistamines are commonly used to treat allergic
conjunctivitis, but use is limited by lack of durable activity and ocular dryness.
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 the potential of
reproxalap as an agent for the treatment of allergic conjunctivitis. 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, 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, 2018, which is expected to be filed with the SEC in the second 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:
Stephen Tulipano
Aldeyra Therapeutics, Inc.
Tel: +1 781-761-4904 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
781-591-3443
cduong@macbiocom.com
View original content:http://www.prnewswire.com/news-releases/aldeyra-therapeutics-announces-first-patient-enrolled-in-allergic-conjunctivitis-phase-3-clinical-trial-300635068.html
SOURCE Aldeyra Therapeutics, Inc.