Aldeyra Therapeutics Receives Fast Track Designation for ADX-2191 for the Prevention of Proliferative Vitreoretinopathy
September 24 2019 - 8:00AM
Business Wire
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today
announced that the U.S. Food and Drug Administration (FDA) has
granted fast track designation to ADX-2191 for the prevention of
proliferative vitreoretinopathy (PVR). PVR is a serious,
sight-threatening condition with no approved treatment.
“Fast track designation is an important milestone for our
retinal disease platform, and promising news for PVR patients,”
said Todd C. Brady, M.D., Ph.D., President and Chief Executive
Officer of Aldeyra. “The FDA’s decision underscores the potential
of ADX-2191 to prevent this devastating condition and creates the
framework for ADX-2191 to reach the market promptly if
approved.”
PVR, a rare inflammatory disorder of the retina that leads to
severe retinal scarring and blindness, occurs most commonly
following retinal detachment repair surgery or ocular injury. More
than 50% of PVR cases result in severe uncorrectable vision loss,
and 76% of PVR patients suffer from at least moderate uncorrectable
vision loss.
Aldeyra expects to initiate its adaptive Phase 3 GUARD Trial of
ADX-2191 for the prevention of PVR in the fourth quarter of 2019.
The trial will compare recurrence rates of PVR-related retinal
detachment across patients treated with ADX-2191 or standard of
care following surgical repair of retinal detachment.
The fast track designation is designed to facilitate the
development and expedite the review of drugs that treat serious
conditions, potentially accelerating patient access to new
therapies.
“Fast track designation enables us to engage in more frequent
communications with the FDA to discuss our development plan for
ADX-2191, and provides eligibility for Priority Review and rolling
New Drug Application submission,” said David J. Clark, M.D., Chief
Medical Officer of Aldeyra. “We look forward to working with the
FDA as we advance ADX-2191 into Phase 3 development.”
About ADX-2191 ADX-2191, an intravitreal formulation of
methotrexate, has been granted orphan drug designation for the
prevention of proliferative vitreoretinopathy (PVR). The observed
clinical activity of ADX-2191 in patients with PVR is believed to
be the result of down-regulation of aberrant retinal cell
proliferation and activity, thereby leading to reduced retinal
scarring that is characteristic of PVR. Aldeyra retains an
exclusive license to certain patents related to the use of ADX-2191
for the prevention 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 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 plans and expectations for the clinical
development and commercialization of ADX-2191 for the prevention of
PVR. 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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version on businesswire.com: https://www.businesswire.com/news/home/20190924005595/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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