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Item 7.01. Regulation FD Disclosure.
On August 8, 2024, Aldeyra Therapeutics, Inc. (the “Company”) issued a press release (the “Press Release”) to announce the achievement of the primary endpoint of ocular discomfort from the Phase 3 dry eye chamber clinical trial of 0.25% reproxalap ophthalmic solution, an investigational new drug candidate, for the treatment of dry eye disease. The Company is holding a conference call regarding the announcement on August 8, 2024. A copy of the supplemental presentation which will be referenced during the conference call and posted on the Company’s website is furnished herewith as Exhibit 99.1 and is incorporated by reference herein.
This information in this Item 7.01 of this Current Report on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing.
Item 8.01. Other Events.
As reported under Item 7.01 of this Current Report on Form 8-K, on August 8, 2024, the Company issued the Press Release to announce the achievement of the primary endpoint of ocular discomfort from the Phase 3 dry eye chamber clinical trial of 0.25% reproxalap ophthalmic solution, an investigational new drug candidate, for the treatment of dry eye disease. The Press Release is filed herewith as Exhibit 99.2 and is incorporated by reference herein.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Aldeyra Therapeutics, Inc. Presentation dated August 8, 2024 | |
| 99.2 | Aldeyra Therapeutics, Inc. Press Release dated August 8, 2024 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ALDEYRA THERAPEUTICS, INC. | ||
| By: | /s/ Todd C. Brady | |
| Name: | Todd C. Brady, M.D., Ph.D. | |
| Title: | Chief Executive Officer | |
Dated August 8, 2024
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Exhibit 99.1
Dry Eye Disease Chamber Phase 3 Clinical Trial of Reproxalap REPROXALAP CLINICAL DEVELOPMENT AND REGULATORY UPDATE August 8, 2024 Nasdaq: ALDX © Aldeyra Therapeutics, Inc. 2024 TOP - LINE RESULTS
2 Disclaimers and Forward - Looking Statements This presentation contains forward - looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Sec urities Exchange Act of 1934, as amended, including statements regarding Aldeyra’s possible or assumed future results of operations, expenses and financing needs, business strategies and plans, stat eme nts regarding Aldeyra's future expectations, plans and prospects, including, without limitation, statements regarding: FDA agreement with the clinical development and regulatory plan for reproxalap; the outcome and timing of the FDA’s review, acceptance, and/or approval of a potential NDA resubmission for reproxalap and the ad equ acy of the data included in the potential NDA resubmission or the supplemental responses to the FDA; the potential for and timing of regulatory approval; Aldeyra’s expecta tio ns regarding the exercise of the AbbVie Option; Aldeyra's goals as to the potential profile and benefit of reproxalap in dry eye disease and allergic conjunctivitis, and its other pro duc t candidates in the indications for which they are developed; anticipated clinical or regulatory milestones for ADX - 2191, ADX - 248, ADX - 743, ADX - 631, and ADX - 629, including expectations regarding the results of scheduled FDA meetings and discussions , clinical trial initiations and completions, and the timing and nature of NDA or other submissions to the FDA; Aldeyra's bus ine ss, research, development and regulatory plans or expectations; political, economic, legal, social, and health risks that may affect Aldeyra’s business or the global economy; the structure, timing, and success of Aldeyra’s planned or pending clinical trials ; and expected milestones, market sizing, pricing and reimbursement, competitive position, regulatory matters, industry envir onm ent, and potential growth opportunities, among other things . The results of earlier preclinical or clinical trials may not be predictive of future results. Forward - looking statements incl ude all statements that are not historical facts and, in some cases, can be identified by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” "could," “can,” “woul d,” “expect,” “believe,” “anticipate,” “project,” “on track,” “scheduled,” “target,” “design,” “estimate,” “predict,” “contemplates,” “likely,” “potential,” “continue,” “ongoing,” “aim,” “plan,” or th e n egative of these terms, and similar expressions intended to identify forward - looking statements. Forward - looking statements involve known and unknown risks, uncertainties and other factors that may cause Aldeyra’s actual resu lts, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward - looking statements. These sta tements reflect Aldeyra’s current views with respect to future events and are based on assumptions and subject to risks and uncertainties, including the development of, and clinical an d regulatory plans or expectations for Aldeyra’s investigational new drugs (including reproxalap, ADX - 2191, ADX - 248, ADX - 743, ADX - 631, and ADX - 629), and systems - based approaches , later developments with the FDA that may be inconsistent with Aldeyra’s expectations and beliefs, including the risk that the results from earlier clinical trials, porti ons of clinical trials, or pooled clinical data may not accurately predict results of subsequent trials or the remainder of a clinical trial for the same or different indications, inconsistent expecta tio ns regarding FDA acceptance and review of the company’s filings and submitted data sets, and Aldeyra’s continuing or post - hoc review and quality control analysis of clinical data. Important fa ctors that could cause actual results to differ materially from those reflected in Aldeyra's forward - looking statements are described in Aldeyra’s most recent Annual Report on Form 10 - K and Qu arterly Report on Form 10 - Q, as well as Aldeyra’s subsequent filings with the Securities and Exchange Commission. All of Aldeyra's development plans and timelines may be subje ct to adjustment depending on funding, recruitment rate, regulatory review, which regulatory review timeline may be flexible and subject to change based on the regulator's workload a nd other potential review issues, preclinical and clinical results, regulatory developments in the United States and other countries, and other factors any of which could result in changes to Aldeyra’s development pla ns and programs or delay the initiation, enrolment, completion, or reporting of clinical trials. In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors als o 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 presentation is pro vid ed only as of August 8 , 2024, and Aldeyra undertakes no obligation to update any forward - looking statements contained in this presentation on account of new information, future events, or otherwise, except as required by law.
3 The Phase 3 Clinical Trial of Reproxalap in a Dry Eye Chamber was Designed to Satisfy the Requirements for NDA Resubmission † z • Randomized, double - masked, vehicle - controlled dry eye chamber challenge Design • Visit 1: Medical screening • Visit 2: Vehicle dry eye chamber (dosing just before and 50 minutes after entry) • Visit 3: Four doses of randomized treatment (reproxalap or vehicle) • Visit 4: Randomized dry eye chamber (dosing just before and 50 minutes after entry) Dosing 132 dry eye disease patients: 66 randomized to reproxalap, 66 randomized to vehicle Size Ocular discomfort score from 80 to 100 minutes Primary Endpoint Safety Other Endpoints Vehicle Chamber Vehicle Chamber Vehicle Chamber Drug Chamber Treatment Arm A: Treatment Arm B: Visit 2 Visit 4 Randomization † NDA submission requirements depend, in part, on regulatory feedback. R egulatory review and discussion timelines are flexible and subject to change based on the regulator's workload and other potential review issues. Topical ocular reproxalap is an investigational new drug candidate that has been st udied 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 tria ls. NDA = New Drug Application.
4 The Phase 3 Dry Eye Chamber Clinical Trial Achieved Success for the Primary Endpoint of Ocular Discomfort P value derived from primary endpoint mixed model for repeated measures analysis. Topical ocular reproxalap is an investigati ona l new drug candidate that has been studied in more than 2,500 patients with no observed safety concerns; mild and transient instillation site irritation is the most commonly reporte d a dverse event in clinical trials. First Dose (Prior to Chamber Entry) Second Dose Primary Endpoint Assessment Period P = 0.004 To our knowledge, the results represent the first positive Phase 3 clinical trial in a dry eye chamber with a symptom as a pr ima ry endpoint, and we believe that the results are supportive of the potential rapid clinical effect of reproxalap on reducing ocular discom for t.
5 Aldeyra Believes that Symptom Requirements for Dry Eye Disease NDA Resubmission Have Been Met The Phase 3 dry eye chamber clinical trial symptom results are consistent with field trial symptom results previously reviewe d b y the FDA. Estimates based on mixed model for repeated measures analysis adjusted for baseline and other factors specified in the Statis tic al Analysis Plans. Topical ocular reproxalap is an investigational new drug candidate that has been studied in more than 2,500 patients with no observed safety concerns; mild a nd transient instillation site irritation is the most commonly reported adverse event in clinical trials. FDA = U.S. Food & Drug Administration.
6 Aldeyra Believes that Positive Results from the Phase 3 Clinical Trial Enable NDA Resubmission † of Reproxalap for Dry Eye Disease • The dry eye chamber clinical trial was designed to satisfy the FDA’s single resubmission requirement of “at least one additional adequate and well - controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye.” • Through the Special Protocol Assessment process and written Advice Letter comments, the FDA provided feedback on the clinical trial protocol and statistical plan. • Aldeyra believes the Phase 3 clinical trial satisfies the FDA’s NDA resubmission requirement. NDA resubmission is anticipated in 2024. Based on FDA guidance, the anticipated review period for the potential NDA resubmission is expected to be six months. † NDA submission requirements depend, in part, on regulatory feedback. Regulatory review and discussion timelines are flexible and subject to change based on the regulator's workload and other potential review issues. Topical ocular reproxalap is an investigational new drug candidate that has been studied in more than 2,500 patients with no obs erved safety concerns; mild and transient instillation site irritation is the most commonly reported adverse event in clinical tria ls. NDA = New Drug Application; FDA = U.S. Food & Drug Administration.
7 Aldeyra has Entered into an Exclusive Option Agreement with AbbVie Inc. for License to Develop and Commercialize Reproxalap Option for AbbVie to obtain: • Co - exclusive license to develop, manufacture, and commercialize reproxalap in the U.S. • Exclusive license to develop, manufacture, and commercialize outside the U.S. Financial terms of license if option exercised: • Upfront payment of $100 million less option fees • $100 million milestone payment upon U.S. FDA approval in dry eye disease • $200 million in additional regulatory and commercial milestones • Profit and loss share (60% for AbbVie/40% for Aldeyra) from commercialization in U.S. • Tiered royalties on net sales outside of U.S. Key Terms of Reproxalap Option Agreement The option terminates on the earlier of (a) the 10th business day after the date on which Aldeyra received approval from the U.S . FDA of the NDA for reproxalap in dry eye disease and (b) the date that is 18 months after October 31, 2023. Topical ocular reproxalap is an investigational new drug candidate that has been studied in more than 2,500 patients w ith no observed safety concerns; mild and transient instillation site irritation is the most commonly reported adverse event in clinical trials.
8 Reproxalap Represents a Novel Potential Therapeutic Approach in Dry Eye Disease with Rapid Activity in Clinical Trials Potential advantages for patients and healthcare providers could effect a paradigm shift relative to standard of care. † Company estimates and Am J Ophthalmol . 2014;157(4):799 - 806. Topical ocular reproxalap is an investigational new drug candidate that has been studied in more than 2,5 00 patients with no observed safety concerns; mild and transient instillation site irritation is the most commonly reported adve rse event in clinical trials. Dry Eye Disease Afflicts 39 Million or More Adults in the U.S. † Rapid and sustained symptom improvement Broad symptomatic activity Acute reduction of ocular redness
Exhibit 99.2
 | News Release |
Aldeyra Therapeutics Achieves Primary Endpoint in Phase 3 Dry Eye Disease Clinical Trial of Reproxalap
New Drug Application Resubmission Anticipated in 2024
Lexington, Mass., August 08, 2024 – 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 achievement of the primary endpoint in a Phase 3 randomized, double-masked, vehicle-controlled dry eye chamber clinical trial of 0.25% reproxalap ophthalmic solution, an investigational new drug candidate, for the treatment of dry eye disease. Reproxalap was statistically superior to vehicle for the prespecified primary endpoint of ocular discomfort (P=0.004), a U.S. Food and Drug Administration (FDA)-accepted symptom of dry eye disease.
“To our knowledge, the results announced today represent the first positive Phase 3 clinical trial in a dry eye chamber with a symptom as a primary endpoint, and we believe that the results are supportive of the potential rapid clinical effect of reproxalap on reducing the ocular discomfort associated with dry eye disease,” stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra.
In the Phase 3 clinical trial, patients were administered vehicle (the drug product without the active ingredient) before and during exposure to a dry eye chamber in a manner that Aldeyra believes is consistent with the FDA’s dry eye disease draft guidance1. Qualifying patients were subsequently randomized to receive either reproxalap or vehicle before and during exposure to an additional dry eye chamber. Of the 132 patients randomized, 66 patients received reproxalap and 66 patients received vehicle. The primary endpoint was ocular discomfort, an FDA-accepted symptom of dry eye disease, from 80 to 100 minutes in the chamber. The dry eye chamber clinical trial was designed to satisfy the FDA’s New Drug Application (NDA) resubmission requirement, identified in the previously received complete response letter, of “at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye.” Through the FDA Special Protocol Assessment process and additional comments, the FDA provided feedback on the clinical trial protocol and statistical plan.
| 1 | www.fda.gov/media/144594/download |
To Aldeyra’s knowledge, in patients with dry eye disease, reproxalap is the first investigational drug with pivotal data supportive of acute and chronic activity in reducing symptoms, and the first investigational drug for chronic administration with pivotal data supportive of acute activity in reducing ocular redness. The potential NDA resubmission is anticipated in 2024. Based on FDA guidance, the resubmission NDA review period is expected to be six months.
There were no safety signals observed in the clinical trial, and reproxalap was observed to be well tolerated. Consistent with prior clinical trials, the most commonly reported adverse event was mild and transient instillation site discomfort. No treatment-related discontinuations were reported. Reproxalap has now been studied in over 2,500 patients.
Conference Call & Webcast Information
Aldeyra will host a conference call at 9:00 a.m. ET today, August 8, 2024, to discuss the Phase 3 dry eye chamber trial results and the plan for resubmission of the NDA for reproxalap in dry eye disease. The dial-in numbers are (888) 596-4144 for domestic callers and (646) 968-2525 for international callers. The access code is 7321123. 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 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.
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.
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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 a potential NDA resubmission for reproxalap and the adequacy of the data included in the original NDA and such 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/.
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.
Investor & Media Contact:
David Burke
Tel: (917) 618-2651
investorrelations@aldeyra.com
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