Aldeyra Therapeutics Announces First Patient Enrolled in the Phase 3 GUARD Trial for Prevention of Proliferative Vitreoretino...
20 December 2019 - 12:00AM
Business Wire
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 enrollment of the first
patient into the Phase 3 GUARD Trial of ADX-2191 for the prevention
of proliferative vitreoretinopathy (PVR). PVR is a serious,
sight-threatening retinal disease with no approved treatment.
“Initiation of patient enrollment in the GUARD Trial marks an
important step toward our goal of improving clinical outcomes for
the thousands of patients with this rare but devastating
condition,” said Todd C. Brady, M.D., Ph.D., President and CEO of
Aldeyra. “Today, the only option for patients who develop PVR is
surgery, which fails in a significant number of cases. ADX-2191 is
a new therapeutic approach with the potential to prevent vision
loss from recurrent retinal detachments.”
The GUARD Trial is a two-part, multi-center, randomized,
controlled, adaptive Phase 3 clinical trial evaluating the efficacy
of intravitreal injections of ADX-2191 versus standard-of-care for
the prevention of PVR. GUARD will compare recurrent retinal
detachment rates over a 24-week period following surgical repair of
retinal detachment due to PVR or open globe injury.
In September 2019, the U.S. Food and Drug Administration (FDA)
granted fast track designation to ADX-2191 for the prevention of
PVR. ADX-2191 has also received orphan drug designation from the
FDA for the prevention of PVR.
More information about the GUARD Trial is available on
www.clinicaltrials.gov (NCT 04136366).
About Proliferative Vitreoretinopathy Proliferative
vitreoretinopathy (PVR) is a rare inflammatory fibroproliferative
disorder that leads to severe retinal scarring and blindness, and
is the leading cause of failure of retinal reattachment surgery.
Approximately 40% to 50% of PVR cases result in severe
uncorrectable vision loss (visual acuity of 20/320 or worse), and
76% of PVR patients suffer from at least moderate uncorrectable
vision loss. PVR complicates up to 10% of surgeries for retinal
detachment and 50% or more of surgeries for open globe injury.
There is currently no approved therapy for the treatment of
PVR.
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 potential 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.
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 of ADX-2191. 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," "on
track," "scheduled," "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
clinical 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 September 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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version on businesswire.com: https://www.businesswire.com/news/home/20191219005140/en/
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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