Aldeyra Therapeutics Resubmits Reproxalap New Drug Application for the Treatment of Dry Eye Disease

Rhea-AI Summary

Aldeyra Therapeutics (Nasdaq: ALDX) has resubmitted a New Drug Application (NDA) to the FDA for topical ocular reproxalap, a potential treatment for dry eye disease. The resubmission includes positive results from a recent dry eye disease symptom trial and a draft label reflecting:

• Acute activity in reducing dry eye symptoms in a chamber trial
• Chronic activity in reducing symptoms in a field trial
• Acute activity in reducing ocular redness in two chamber trials

In August 2024, Aldeyra announced achieving the primary endpoint in a Phase 3 trial, demonstrating reproxalap's statistical superiority over vehicle for ocular discomfort (P=0.004). The company believes this supports reproxalap's potential for rapid clinical effect in reducing dry eye discomfort.

Positive

• Resubmission of NDA for reproxalap in dry eye disease treatment
• Positive results from recent dry eye disease symptom trial
• Achieved primary endpoint in Phase 3 trial (P=0.004)
• Potential to be first dry eye therapy for chronic use with acute symptom reduction

Negative

• None.

Insights

Biotech Analyst

The resubmission of the NDA for reproxalap is a significant milestone for Aldeyra Therapeutics. The inclusion of positive results from a recently completed dry eye disease symptom trial, as requested by the FDA, strengthens the application. Notably, the draft label reflects acute and chronic activity in reducing dry eye symptoms and ocular redness, addressing key patient concerns.

The potential for reproxalap to be the first dry eye disease therapy for chronic use with pivotal data demonstrating acute symptom relief could be a game-changer in the $5 billion global dry eye market. The positive Phase 3 results, particularly the statistically significant improvement in ocular discomfort (P=0.004), provide robust clinical evidence.

Investors should note the potential 6-month review timeline, which could lead to a decision by mid-2024. If approved, Aldeyra could capture a significant market share, given the unmet need for rapid-acting, chronic-use treatments. However, regulatory risks remain and competition in the dry eye space is intense.

Market Research Analyst

The dry eye disease market presents a substantial opportunity for Aldeyra. With an aging population and increasing screen time, the prevalence of dry eye disease is rising. Current treatments often have limitations in onset of action or suitability for chronic use.

Reproxalap's potential dual action in addressing both signs and symptoms of dry eye disease could differentiate it from existing therapies. The market has been receptive to novel treatments, as evidenced by the success of Xiidra and Cequa in recent years.

If approved, Aldeyra will need to execute a strong commercialization strategy to compete with established players like Allergan (AbbVie) and Novartis. Pricing, reimbursement and physician education will be critical factors. The company's ability to effectively launch and scale distribution will be key indicators for investors to watch post-approval.

LEXINGTON, Mass.--(BUSINESS WIRE)-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases, today announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap, an investigational new drug candidate, for the treatment of signs and symptoms of dry eye disease. The resubmission includes previously disclosed positive results from a recently completed dry eye disease symptom trial requested by the FDA following review of the previously submitted NDA, as well as a draft label reflecting acute activity in reducing dry eye symptoms in a dry eye chamber trial, chronic activity in reducing dry eye symptoms in a field trial, and acute activity in reducing ocular redness in two dry eye chamber trials.

“If approved, reproxalap would have the potential to be the first dry eye disease therapy for chronic use with pivotal data demonstrating acute activity in reducing dry eye symptoms and ocular redness, two characteristics of dry eye disease of primary importance to patients,” stated Todd C. Brady, M.D., Ph.D., Aldeyra’s President and Chief Executive Officer.

In August 2024, Aldeyra announced the achievement of the primary endpoint in a Phase 3 randomized, double-masked, vehicle-controlled dry eye chamber clinical trial of reproxalap in patients with dry eye disease. Reproxalap was statistically superior to vehicle for the prespecified primary endpoint of ocular discomfort (P=0.004), an FDA-accepted symptom of dry eye disease. To Aldeyra’s knowledge, the results represented the first positive Phase 3 clinical trial in a dry eye chamber with a symptom as a primary endpoint, and Aldeyra believes that results are supportive of the potential rapid clinical effect of reproxalap on reducing the ocular discomfort associated with dry eye disease.

The Prescription Drug User Fee Act target guidelines for NDA resubmissions include acknowledgment of acceptance for review within 30 days of submission, and completion of submission review within 6 months.

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, which are elevated in ocular and systemic inflammatory diseases. 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 2,500 patients with no observed safety concerns; mild and transient instillation site irritation is the most commonly reported adverse event in clinical trials.

About Aldeyra

Aldeyra Therapeutics is a biotechnology company devoted to discovering innovative therapies designed to treat immune-mediated and metabolic diseases. Our approach is to develop pharmaceuticals that modulate protein 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-248, ADX-743, ADX-631, and chemically related molecules for the potential treatment of systemic and retinal immune-mediated and metabolic diseases. Our late-stage 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 retinitis pigmentosa.

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 Aldeyra’s future expectations, plans, and prospects, including without limitation statements regarding: the goals, opportunity, and potential for reproxalap; the outcome and timing of the FDA’s review, acceptance and/or approval of the NDA resubmission for reproxalap and the adequacy of the data included in the previously submitted NDA and the NDA resubmission; and Aldeyra’s expectations regarding the labeling for reproxalap, if approved. 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 Aldeyra's product candidates, including as a result of the FDA not accepting Aldeyra’s regulatory filings, issuing a complete response letter, 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, 2023, and Aldeyra’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, expected to be filed with the SEC in the fourth quarter of 2024.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241003572695/en/

Investor & Media Contact:

David Burke

Tel: (917) 618-2651

investorrelations@aldeyra.com

Source: Aldeyra Therapeutics, Inc.

FAQ

What is the status of Aldeyra's (ALDX) New Drug Application for reproxalap?

Aldeyra Therapeutics has resubmitted a New Drug Application (NDA) to the FDA for topical ocular reproxalap for the treatment of signs and symptoms of dry eye disease.

What were the results of Aldeyra's (ALDX) Phase 3 trial for reproxalap in dry eye disease?

In August 2024, Aldeyra announced that reproxalap achieved the primary endpoint in a Phase 3 trial, demonstrating statistical superiority over vehicle for ocular discomfort (P=0.004) in patients with dry eye disease.

What potential advantages does Aldeyra (ALDX) claim for reproxalap in dry eye disease treatment?

Aldeyra claims that if approved, reproxalap could be the first dry eye disease therapy for chronic use with pivotal data demonstrating acute activity in reducing both dry eye symptoms and ocular redness.

When can Aldeyra (ALDX) expect a response from the FDA regarding the reproxalap NDA resubmission?

According to Prescription Drug User Fee Act guidelines, Aldeyra can expect acknowledgment of acceptance for review within 30 days of submission, and completion of submission review within 6 months.