Primary Endpoints of Treatment-Related
Serious Adverse Events in Ocular Safety Parameters Were Not
Observed
Ocular Safety Events Were Similar Across
Reproxalap and Vehicle Groups
In Post-Hoc Analysis, Reproxalap Potentially
the First Chronically Administered Topical Ocular Therapy to
Demonstrate Distance Visual Acuity Improvement in Adults
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today
announced top-line results from a 12-month, vehicle-controlled,
multicenter, parallel-group safety clinical trial of reproxalap, an
investigational new drug, in dry eye disease patients. The primary
endpoints of treatment-related serious adverse events in ocular
safety were not observed in any patient. Ocular safety events were
similar across reproxalap and vehicle treatment groups. In a
post-hoc analysis, reproxalap was statistically superior to vehicle
in improvement from baseline in distance visual acuity, potentially
representing the first demonstration of improvement in distance
visual acuity with a topically administered therapy.
“The lack of treatment-related serious adverse events over 12
months confirms the safety profile of reproxalap observed in prior
clinical trials, and the potentially landmark evidence of
improvement in visual acuity may differentiate reproxalap, if
approved for sale, from other therapeutic options for the treatment
of dry eye disease,” stated Todd C. Brady, M.D., Ph.D., President
and Chief Executive Officer of Aldeyra.
The 12-month safety clinical trial population was comprised of
447 dry eye disease patients; 299 patients were treated with
reproxalap and 148 patients were treated with vehicle. Visual
acuity and ocular safety assessments, including assessment of
intraocular pressure, slit-lamp examination, corneal endothelial
cell density, and dilated fundoscopy, were performed at baseline,
and after 4 weeks, 6 weeks, 3 months, 6 months, and one year of
treatment. The primary endpoints were the proportion of
treatment-related ocular safety events related to visual acuity,
intraocular pressure, slit-lamp examination, and dilated fundoscopy
in reproxalap-treated patients compared to vehicle-treated
patients. Change from baseline in visual acuity, as assessed by the
logarithm of the minimum angle of resolution (logMAR, lower values
indicate better visual acuity), was analyzed post-hoc over 12
months using a repeated measures analysis.
No serious adverse events related to treatment were observed in
any patient. Ocular safety parameters were similar between
treatment groups. Consistent with prior experience with reproxalap
and other topical ocular medications, the most common adverse event
in reproxalap-treated patients was mild and transient instillation
site irritation.
Visual acuity improved over 12 months in both treatment groups,
and improvement in patients treated with reproxalap was
statistically superior (P=0.018) to that in patients treated with
vehicle. In the reproxalap treatment group, logMAR improved by
approximately 37% (P<0.0001), from 0.13 (Snellen 20/27) to 0.08
(Snellen 20/24).
Reproxalap has now been tested in more than 2,300 patients with
no safety concerns identified. The detailed results of the clinical
trial are expected to be presented at a major medical meeting.
“The long-term safety results announced today complement the
broad activity of reproxalap evidenced across a number of
late-stage clinical trials in dry eye disease,” stated John
Sheppard, M.D., M.M.Sc., President of Virginia Eye Consultants and
Professor of Ophthalmology, Microbiology, and Molecular Biology at
Eastern Virginia Medical School. “The potential improvement in
distance vision observed over one year of treatment is, in my
experience, unprecedented for a topical ocular therapy and is
consistent with reduction of the inflammation characteristic of dry
eye disease.”
About Reproxalap
Reproxalap, an investigational new drug candidate, is a
first-in-class small-molecule modulator of RASP (reactive aldehyde
species), which are elevated in ocular and systemic inflammatory
disease. The mechanism of action of reproxalap has been supported
by the demonstration of statistically significant and clinically
relevant activity in dry eye disease and other physiologically
distinct late-phase clinical indications. Dry eye disease is a
common inflammatory disease estimated to affect 39 million or more
adults in the United States.1 The disease is characterized by
insufficient moisture and lubrication in the anterior surface of
the eye, leading to dryness, inflammation, pain, discomfort,
irritation, diminished quality of life, and in severe cases,
permanent vision impairment. Among many physicians and patients,
existing therapy for dry eye disease is generally regarded as
inadequate and often requires weeks or months to demonstrate
activity. In patients with dry eye disease, RASP may contribute to
ocular inflammation, diminished tear production, ocular redness,
and changes in tear lipid composition.2 By diminishing RASP levels,
reproxalap represents a novel and differentiated approach for the
treatment of the symptoms and signs of dry eye disease.
About Aldeyra
Aldeyra Therapeutics is a clinical-stage biotechnology company
developing innovative therapies designed to treat immune-mediated
diseases. Our approach is to discover and develop pharmaceuticals
that modulate immunological systems, instead of directly inhibiting
or activating single protein targets, with the goal of optimizing
multiple pathways at once while minimizing toxicity. Our product
candidates include RASP (reactive aldehyde species) modulators
ADX-629, ADX-246, ADX-248, and chemically related molecules for the
potential treatment of systemic and retinal immune-mediated
diseases. Our pre-commercial product candidates are reproxalap, a
RASP modulator for the potential treatment of dry eye disease
(under U.S. Food and Drug Administration New Drug Application
review) and allergic conjunctivitis, and ADX-2191, a novel
formulation of intravitreal methotrexate for the potential
treatment of primary vitreoretinal lymphoma (under U.S. Food and
Drug Administration New Drug Application review), proliferative
vitreoretinopathy, and other rare sight-threatening retinal
diseases. For more information, visit https://www.aldeyra.com/ and
follow us on LinkedIn, Facebook, and Twitter.
Safe Harbor Statement
This release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including, but not limited to, statements relating to the
expectations regarding the clinical data from its 12-month safety
clinical trial of reproxalap in patients with dry eye disease, the
post-hoc analysis of the 12-month safety clinical trial and the
potential to demonstrate distance visual acuity improvement in
adults, expectations regarding evidence of acuity improvements and
differentiation of reproxalap, if approved for sale, from other
therapeutic options. 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,” “on schedule,” “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 are
subject to adjustment depending on recruitment rate, regulatory
review, which regulatory review timeline may be flexible and
subject to change based on the regulator’s workload and other
potential review issues, preclinical and clinical results, funding,
and other factors that could delay the initiation, enrollment 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,
Aldeyra’s plans to develop and commercialize product candidates, if
they are approved; 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; uncertainty as to Aldeyra’s
ability to commercialize (alone or with others) and obtain
reimbursement for 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; the rate and degree of market acceptance of any of
Aldeyra's product candidates; the rate and degree of market
acceptance of any of Aldeyra’s product candidates, following
regulatory approval, if any; 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; 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 in clinical trials focused on the same
or on different indications; the scope, progress, expansion, and
costs of developing and commercializing Aldeyra's product
candidates; the current and potential future impact of the COVID-19
pandemic on Aldeyra’s business, results of operations and financial
position; Aldeyra's expectations regarding Aldeyra's expenses and
future revenue, the timing of future revenue, the sufficiency or
use of Aldeyra's cash resources and needs for additional financing;
Aldeyra's expectations regarding competition; Aldeyra's anticipated
growth strategies; Aldeyra's ability to attract or retain key
personnel; Aldeyra’s commercialization, marketing and manufacturing
capabilities and strategy; 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; political, economic, legal, social, and health risks,
including the COVID-19 pandemic and subsequent public health
measures, and war or other military actions, that may affect
Aldeyra’s business or the global economy; 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, 2021, and Aldeyra’s Quarterly Report on
Form 10-Q for the quarter ended September 30, 2022, which are on
file with the Securities and Exchange Commission (SEC) and
available on the SEC's website at https://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, 2022, expected
to be filed with the SEC in the first quarter of 2023.
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.
1 Company estimates and Paulsen AJ, Cruickshanks KJ, Fischer ME,
et al. Dry eye in the beaver dam offspring study: prevalence, risk
factors, and health-related quality of life. Am J Ophthalmol.
2014;157(4):799-806. 2 Choi W, Lian C, Ying L, Kim GE, You IC, Park
SH, Yoon KC. Expression of Lipid Peroxidation Markers in the Tear
Film and Ocular Surface of Patients with Non-Sjogren Syndrome:
Potential Biomarkers for Dry Eye Disease. Curr Eye Res. 2016
Sep;41(9):1143-9. doi: 10.3109/02713683.2015.1098707. Epub 2016 Jan
5. PMID: 26731289.
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Investor & Media Contact: Scott Solomon Sharon Merrill
Associates, Inc. Tel: (857) 383-2409 ALDX@investorrelations.com
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