- Primary Endpoint of Symptom Control Achieved in Phase 2 Dry Eye
Disease Formulation Clinical Trial
- Statistically Significant Combined Data Across Multiple Dry Eye
Disease Clinical Trials Suggests Potential Early and Potent
Activity in Signs and Symptoms
- In Head-to-Head Clinical Trial, Tolerability of Reproxalap
Superior to that of Xiidra® in Dry Eye Disease Patients over One
Hour After Instillation
- Leading Ocular Surface Disease Expert Dr. Paul Karpecki to
Highlight Treatment Challenges in Allergic Conjunctivitis and Dry
Eye Disease
- Live Webcast Scheduled to Begin at Noon ET Today
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today will
host the 2020 Research & Development Day (R&D Day) with
investors and financial analysts in New York City to present recent
clinical development updates and market opportunities for its novel
investigational new drug product candidates in dry eye disease,
allergic conjunctivitis, and proliferative vitreoretinopathy. The
event will include presentations from members of the Aldeyra
executive team and Paul Karpecki, O.D., FAAO. Dr. Karpecki is
Clinical Director, Corneal Services and Advanced Ocular Surface
Disease at Kentucky Eye Institute and a clinician for Gaddie Eye
Centers.
Aldeyra will announce that the Phase 2 novel formulation
clinical trial in dry eye disease achieved the primary endpoint of
symptom control. The double-masked, randomized, vehicle-controlled,
multi-center, parallel-group clinical trial assessed the efficacy
and safety of a novel formulation of 0.25% reproxalap topical
ophthalmic solution compared to vehicle in 206 patients with
moderate to severe dry eye disease. Relative to the formulation of
0.25% reproxalap topical ophthalmic solution used in prior clinical
trials, the concentration of a single excipient was increased in
the novel formulation. The primary efficacy endpoint was change
from baseline versus vehicle in patient-reported ocular dryness
score over two to twelve weeks of treatment. Relative to patients
treated with vehicle, patients treated with reproxalap demonstrated
statistically significant reduction in ocular dryness (p=0.03).
Based on the results across the clinical studies conducted in dry
eye disease to date, Aldeyra plans to meet with the U.S. Food and
Drug Administration (FDA) prior to initiating Part 2 of the RENEW
Trial and expects to provide an update on future development plans
in dry eye disease following FDA feedback.
In addition, Aldeyra will present novel combined data analyses
from the Phase 2b clinical trial and Part 1 of the Phase 3 RENEW
Trial in dry eye disease. The analyses included approximately 460
patients treated with reproxalap for up to four weeks, during which
site visits, formulation, and dosing regimen were the same across
the trials. Statistically significant improvement over vehicle was
demonstrated in the combined data for ocular dryness (p = 0.008)
and nasal region fluorescein staining (p = 0.003).
Topical ocular reproxalap has now been studied in over 1,100
patients with no observed safety concerns reported; mild
instillation site irritation is the most commonly reported adverse
event in clinical trials.
Aldeyra will also present the results of a head-to-head
tolerability clinical trial of the current formulation of
investigational new drug reproxalap and the novel formulation of
reproxalap versus Xiidra® (lifitegrast ophthalmic solution) over
one hour after drop instillation. The tolerability of both
formulations of reproxalap, as assessed by a variety of drop
experience scores including ocular discomfort, blurry vision, and
taste disturbance, was statistically superior to that of Xiidra®.
In a crossover design with a three-day washout period between
visits, nineteen patients were exposed at each visit to either
Xiidra®, the current formulation of reproxalap, or the novel
formulation of reproxalap. No statistical differences were noted in
tolerability between the current formulation of reproxalap and the
novel formulation of reproxalap. The trial compared only
tolerability under the aforementioned conditions.
“Reproxalap has now met pre-specified and FDA-sanctioned symptom
endpoints in the formulation trial and in Part 1 of the RENEW
Trial,” said Todd Brady, M.D., Ph.D., President and CEO of Aldeyra.
“The recent clinical results, in addition to the combined trial
analyses and head-to-head tolerability data released today,
highlight a compelling development program for what we continue to
believe could be the next novel entrant in the dry eye disease
market.”
Topical ocular reproxalap is also being investigated in patients
with allergic conjunctivitis in the Phase 3 INVIGORATE Trial. The
INVIGORATE Trial, which will enroll approximately 120 patients, is
a randomized, double-masked, crossover vehicle-controlled Phase 3
clinical trial to assess the efficacy and safety of 0.25%
reproxalap topical ophthalmic solution compared to vehicle using an
allergen chamber. Consistent with the company’s prior allergic
conjunctivitis trials, the primary endpoint will be
subject-reported ocular itching score. Top-line results from the
INVIGORATE Trial are expected in the second half of 2020. In 2019,
Aldeyra announced achievement of the primary endpoint of the Phase
3 ALLEVIATE Trial in allergic conjunctivitis, as well as
statistically significant reductions in ocular itching and redness
in an allergen chamber clinical trial.
Aldeyra will present an updated market assessment of allergic
conjunctivitis, which affects more than 1 billion people
worldwide,1 including more than 100 million in the U.S.2 The signs
and symptoms of allergic conjunctivitis – ocular itching, redness,
and tearing – are persistently disturbing, affecting quality of
life and leading to loss of work that can create a substantial
economic burden for patients and families.3 The prevalence of
allergic conjunctivitis is growing due to longer allergy seasons
and the geographic spread of allergen-producing plants.
During Aldeyra’s R&D Day, Dr. Paul Karpecki, a leading and
internationally recognized expert in ocular surface disease, will
discuss the clinical overlap between allergic conjunctivitis and
dry eye disease, two of the most common anterior ocular
inflammatory diseases. Allergic conjunctivitis and dry eye disease
collectively represent the majority of inflammatory ocular surface
disease, which affects more than 40% of people in the U.S.4
“Inflammation is the common component of all ocular surfaces
diseases, and it can often be difficult for doctors to
differentiate between dry eye disease and allergic conjunctivitis,”
Dr. Karpecki said. “Many patients do not respond to currently
available dry eye disease or allergic conjunctivitis therapies, and
corticosteroids have long-term risks and side effects. Thus, there
is a significant unmet medical need for a novel therapeutic option
such as reproxalap, which has the potential to treat inflammation
in multiple ocular surface diseases.”
Aldeyra will also highlight the challenging patient experience
with proliferative vitreoretinopathy (PVR), a serious,
sight-threatening retinal disease with no approved treatment.
Aldeyra is currently testing ADX-2191, an anti-inflammatory and
anti-proliferative agent, in the Phase 3 GUARD Trial, a two-part,
multi-center, randomized, controlled, adaptive clinical trial
evaluating the efficacy of intravitreal injections of ADX-2191
versus standard-of-care for the prevention of PVR. The GUARD Trial
will compare recurrent retinal detachment rates over a 24-week
period following surgical repair of retinal detachment due to PVR
or open globe injury. Patient enrollment in the GUARD Trial began
in December 2019.
The R&D Day presentations are scheduled to begin at Noon
(ET) today, February 24, 2020, in New York, NY. A live audio
webcast of the presentation and a slide deck will be available via
the company's Investor Relations website at
https://ir.aldeyra.com/. Following the live webcast, an archived
version will be available on the website for 90 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 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 the clinical development or
commercial potential of reproxalap, the novel formulation of
reproxalap and 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. Additional factors may be set forth in
those sections of Aldeyra’s Annual Report on Form 10-K for the year
ended December 31, 2019, expected to be filed with the SEC in the
first quarter of 2020.
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.
1White Book on Allergy (2013 Update)
2Singh K, Axelrod S, Bielory L. The epidemiology of ocular and
nasal allergy in the United States, 1988-1994.J Allergy
ClinImmunol.2010;126(4):778-783.e6
3 Andrew D. Pitt, Andrew F. Smith, Lynda Lindsell, Li Wern Voon,
Peter W. Rose & Anthony J. Bron (2004) Economic and
quality-of-life impact of seasonal allergic conjunctivitis in
Oxfordshire, Ophthalmic Epidemiology, 11:1, 17-33, DOI:
10.1076/opep.11.1.17.26437
4Khan RS, Rizvi S, Syed BA, Bielory L. Curr Opin Allergy Clin
Immunol. 2019 Oct;19(5):503-509. doi:
10.1097/ACI.0000000000000562
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200224005455/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
Aldeyra Therapeutics (NASDAQ:ALDX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Aldeyra Therapeutics (NASDAQ:ALDX)
Historical Stock Chart
From Apr 2023 to Apr 2024
