- Additional Trial Required to Demonstrate Positive Effect on
the Treatment of Ocular Symptoms in Dry Eye Disease
- Special Protocol Assessment Submitted on November 16, 2023
for Dry Eye Disease Chamber Crossover Clinical Trial
- Proposed Trial Top-Line Results and Potential NDA
Resubmission Anticipated in First Half of 2024
- Cash Runway Extended into Late 2025
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a
biotechnology company devoted to discovering and developing
innovative therapies designed to treat immune-mediated diseases,
today announced receipt of a Complete Response Letter from the U.S.
Food and Drug Administration (FDA) for the New Drug Application
(NDA) of reproxalap, an investigational drug candidate, for the
treatment of dry eye disease. Although no safety or manufacturing
issues with reproxalap were identified, the FDA stated in the
letter that the NDA did not demonstrate “efficacy in treating
ocular symptoms associated with dry eyes” and that “at least one
additional adequate and well-controlled study to demonstrate a
positive effect on the treatment of ocular symptoms of dry eye”
should be conducted.
Per draft FDA dry eye disease guidance, efficacy in dry eye
disease may be demonstrated with two symptom trials and two sign
trials. Among other clinical trials, Aldeyra previously conducted
two trials for ocular redness (a dry eye disease sign) as well as a
dry eye disease symptom trial. On November 16, 2023, Aldeyra
submitted to the FDA a Special Protocol Assessment (SPA) for a dry
eye disease chamber crossover clinical trial (the proposed trial)
similar to the crossover chamber trial from which Aldeyra announced
results on July 12, 2022. The SPA review cycle is anticipated to be
45 days, and Aldeyra expects FDA feedback from the SPA in December
of 2023. The proposed trial is expected to cost less than $2
million, and top-line results are anticipated in the first half of
2024, subject to FDA feedback on the SPA.
The potential NDA resubmission is anticipated in the first half
of 2024, pending FDA SPA feedback and positive results from the
proposed trial. Aldeyra intends to include in the potential NDA
resubmission a draft label describing chronic and acute symptomatic
benefit, in addition to acute reduction in ocular redness of
reproxalap. The review period for the potential NDA resubmission is
expected to be six months.
“With $143 million in cash, cash equivalents, and marketable
securities as of September 30, 2023, we are well positioned to
conduct another symptom trial of reproxalap in patients with dry
eye disease, with a potential NDA resubmission in the first half of
2024,” stated Todd C. Brady, M.D., Ph.D., President and Chief
Executive Officer of Aldeyra Therapeutics. “If the SPA and proposed
trial results are successful, and the potential resubmitted NDA is
approved, the drug label may be the first label in dry eye disease
to contain acute reduction in ocular redness, as well as a
combination of chronic and acute symptomatic benefit, potentially
highlighting the rapid activity of reproxalap on both signs and
symptoms of dry eye disease.”
Reproxalap is also under development for the treatment of
allergic conjunctivitis, a common inflammatory disease that affects
an estimated 20% of the worldwide population. Results from the
third positive Phase 3 clinical trial of reproxalap in allergic
conjunctivitis, the INVIGORATE-2 Trial, were announced on June 15,
2023. Aldeyra plans to conduct a Type C meeting with the FDA in the
first half of 2024 to discuss the potential NDA submission of
reproxalap for the treatment of allergic conjunctivitis.
Aldeyra is extending previous cash runway guidance into late
2025, including clinical trial costs associated with the proposed
trial and potential NDA resubmission; the initial commercialization
and launch plans for reproxalap, if approved in late 2024; and
continued early and late-stage development of its product
candidates in ocular and systemic immune-mediated diseases. The
extended cash runway guidance is based on Aldeyra’s current
operating plan, which excludes any potential licensing or product
revenue associated with reproxalap.
Conference Call & Webcast Information
Aldeyra will host a conference call at 8:00 a.m. ET tomorrow,
November 28, 2023, to provide a regulatory update on reproxalap.
The dial-in numbers are (833) 470-1428 for domestic callers and
(404) 975-4839 for international callers. The access code is
334884. A live audio webcast of the conference call also will be
accessible from the “Investors & Media” section of Aldeyra's
website at ir.aldeyra.com. A live webcast of the conference call
will be available on the Investor Relations page of the company’s
website at https://ir.aldeyra.com. After the live webcast, the
event will remain archived on the Aldeyra Therapeutics website for
90 days.
About Aldeyra
Aldeyra Therapeutics is a biotechnology company devoted to
discovering innovative therapies designed to treat immune-mediated
diseases. Our approach is to 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 and
allergic conjunctivitis, and ADX-2191, a novel formulation of
intravitreal methotrexate for the potential treatment of
proliferative vitreoretinopathy and retinitis pigmentosa.
About Reproxalap
Reproxalap is an investigational new drug candidate in
development for the treatment of dry eye disease and allergic
conjunctivitis, two of the largest markets in ophthalmology.
Reproxalap 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 multiple
physiologically distinct late-phase clinical indications.
Reproxalap has been studied in more than 2,400 patients with no
observed safety concerns; mild and transient instillation site
irritation is the most commonly reported adverse event in clinical
trials.
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 regarding the outcome and
timing of the FDA’s potential feedback on the SPA; the outcome and
expected timing and the results of the proposed trial (as defined
above); the outcome and timing of the FDA’s review, acceptance
and/or approval of a potential NDA resubmission for reproxalap and
the adequacy of the data included in the original NDA and the
potential NDA resubmission; Aldeyra’s expectations regarding the
labeling for reproxalap, if approved; Aldeyra’s projected cash
runway; Aldeyra’s ability to successfully commercialize (alone or
with others) reproxalap; Aldeyra’s expectations regarding the
development of reproxalap for the treatment of allergic
conjunctivitis; and Aldeyra’s expectations regarding timing and
results of potential or scheduled FDA meetings, including the
planned Type C meeting with the FDA to discuss the development of
reproxalap for the treatment of allergic conjunctivitis. 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,” “contemplates,” “likely,”
“potential,” “continue,” “ongoing,” “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, 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, 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;
delay in or failure to obtain regulatory approval of reproxalap or
Aldeyra's other product candidates, including as a result of the
FDA not accepting Aldeyra’s regulatory filings, issuing a complete
response letter, providing feedback and/or rejecting the SPA, or
requiring additional clinical trials or data prior to review or
approval of such filings or in connection with resubmissions of
such filings; 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 in clinical trials focused on the same or
different indications; 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) 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; 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; 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 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,
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, 2022, and Aldeyra’s Quarterly Report on
Form 10-Q for the quarter ended September 30, 2023, 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, 2023, expected
to be filed with the SEC in the first quarter of 2024, and
Aldeyra’s other filings with the SEC.
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/20231127889140/en/
Investors & Media: David Burke Tel: (917) 618-2651
investorrelations@aldeyra.com
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