LEXINGTON, Mass., Feb. 21, 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 the results of the Phase 2a clinical trial of
topical ocular reproxalap in dry eye disease were selected for podium presentation at the 2018 Association for Research in Vision
and Ophthalmology (ARVO) Annual Meeting, which will take place from April 29 th to
May 3 rd in Honolulu, Hawaii. In addition, posters will
be presented on the results of the Phase 2b clinical trial of topical ocular reproxalap in allergic
conjunctivitis, the activity of ADX-103 in a model of diabetic macular edema, and the activity of reproxalap and ADX-103 in
models of retinal inflammation and dry age-related macular degeneration.
"We are excited about Aldeyra's growing presence at ARVO this year, reflecting the expansion of our immune-modulating platform
from anterior ocular diseases to the retina," commented Todd C. Brady, M.D., Ph.D., President and
CEO of Aldeyra. "The selection of our Phase 2a dry eye disease clinical results for podium presentation highlights the
potential of aldehyde sequestration for the treatment of inflammatory disorders."
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Paper presentation details are as follows:
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Title:
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A Randomized, Double-Masked, Parallel-Group, Phase 2a Dry Eye Disease
Clinical Trial to Evaluate the Safety and Efficacy of Topical Ocular ADX-102, a Novel Aldehyde Sequestering Agent
(Abstract # 2911421)
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Presenter:
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David Clark, M.D., Chief Medical Officer, Aldeyra Therapeutics
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Session:
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Dry Eye Clinical, Session # 265
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Location:
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Room 312, Presentation # 1967
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Date/Time:
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April 30, 2018, 4:45pm to 5:00pm HAST
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Poster presentation details are as follows:
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Title:
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ADX-103, a Novel Small Molecule Aldehyde Sequestering Agent, Decreases
Retinal Edema and Inflammation in a Rat Model of Diabetic Macular Edema (Abstract # 2922576)
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Presenter:
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Adna Halilovic, Ph.D., Scientific Affairs Manager, Aldeyra
Therapeutics
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Session:
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Diabetic retinopathy; Session # 110
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Location:
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Poster Board # 198 - C0009
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Date:
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April 29, 2018 from 8:15 AM to 10:00 AM HAST
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Title:
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Novel Small Molecule Aldehyde Sequestering Agents Demonstrate Broad
Therapeutic Potential for Ocular Inflammation (Abstract # 2917825)
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Presenter:
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Susan G. Macdonald, Ph.D., Vice President, Research and Development,
Aldeyra Therapeutics
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Session:
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Toxicology, anti-inflammatory, antibiotics; Session # 313
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Location:
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Poster Board # 2663 - A0390
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Date:
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May 1, 2018 from 8:15am to 10:00am HAST
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Title:
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A Randomized, Multi-Center, Double-Masked, Vehicle-Controlled,
Parallel-Group Phase 2b Allergic Conjunctivitis Clinical Trial of Topical Ocular ADX-102, a Novel Aldehyde Sequestering
Agent (Abstract # 2913313)
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Presenter:
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Paul Gomes, Vice President – Allergy, Ora, Inc.
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Session:
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Conjunctival Allergic Disease, Session # 511
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Location:
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Poster Board # 5571 - A0263
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Date:
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May 3, 2018 from 8:15am to 10:00am HAST
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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. The company is also developing other product candidates for systemic inflammatory disease. Aldeyra intends to
commercialize its products directly and through collaborations that expand global reach. 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. In patients with dry eye disease,
pro-inflammatory aldehyde mediators may contribute to ocular inflammation. By diminishing aldehyde levels, Aldeyra's topical
ocular aldehyde trap platform represents a novel and differentiated approach for the treatment of dry eye disease.
About Allergic Conjunctivitis
Allergic conjunctivitis is a common allergic disease that affects 20% or more of the population worldwide. The disease
is thought to be mediated in part by pro-inflammatory aldehydes, and 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. Treatment of the symptoms of allergic conjunctivitis often involves antihistamines, the use of which is limited, in part
due to ocular dryness and the lack of sustained activity.
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; the potential of
aldehyde sequestration for the treatment of inflammatory disorders; and the potential of reproxalap as an agent for the treatment
of dry eye disease. 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 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, 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, 2016 and Quarterly Report on Form 10-Q for the quarter ended September
30, 2017, 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 described in those sections of Aldeyra's Annual Report on Form 10-K for the
year ended December 31, 2017, expected to be filed with the SEC in the first 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 or completion 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
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SOURCE Aldeyra Therapeutics, Inc.