UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 7.01. | Regulation FD Disclosure. |
As reported under Item 8.01 of this Current Report on Form 8-K, on April 3, 2025, Aldeyra Therapeutics, Inc. (“Aldeyra” or the “Company”) issued a press release (the “Press Release”) to provide a regulatory update regarding reproxalap, an investigational drug candidate, for the treatment of dry eye disease. The Company will hold a conference call regarding this announcement on April 3, 2025. 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 to this Current Report on Form 8-K 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. |
On April 3, 2025, Aldeyra issued the Press Release to announce that it had received a Complete Response Letter (“2025 Complete Response Letter”) from the U.S. Food & Drug Administration (“FDA”) regarding the Company’s resubmitted New Drug Application (“resubmitted NDA”) for reproxalap, an investigational drug candidate, for the treatment of dry eye disease. In the 2025 Complete Response Letter, the FDA stated that the NDA “failed to demonstrate efficacy in adequate and well controlled studies 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. The letter identified concerns with the data from the trial submitted to the NDA that may have affected interpretation of the results, which the FDA stated may be related to methodological issues, including a difference in baseline scores across treatment arms. The Press Release is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated by reference herein.
The following risk factor is provided to supplement Aldeyra’s risk factors previously disclosed under the heading “Risk Factors” in Aldeyra’s Annual Report on Form 10-K for the year ended December 31, 2024.
Aldeyra’s success in obtaining regulatory approval of reproxalap from the FDA depends on Aldeyra’s ability to address the issues raised by the FDA in the 2025 Complete Response Letter, and address any issues the FDA may raise in the future.
Aldeyra resubmitted an NDA for reproxalap for the treatment of the signs and symptoms of dry eye disease in October 2024. In November 2024, the FDA accepted the reproxalap NDA for filing and set a Prescription Drug User Fee Act date of April 2, 2025. On April 3, 2025, Aldeyra announced that it had received the 2025 Complete Response Letter from the FDA. In the 2025 Complete Response Letter, the FDA stated that the NDA “failed to demonstrate efficacy in adequate and well controlled studies 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. The letter identified concerns with the data from the trial submitted to the NDA that may have affected interpretation of the results, which the FDA stated may be related to methodological issues, including a difference in baseline scores across treatment arms. Aldeyra expects to announce results from two additional dry eye disease trials in the second quarter of 2025. There can be no assurance that the results from either trial will be positive. Pending positive results and discussions with the FDA, Aldeyra intends to resubmit the NDA mid-year 2025. In connection with the review of a potential NDA resubmission, the FDA could require additional studies or clinical trials, and the submission of the results of those studies or clinical trials before a potential NDA resubmission will be reconsidered, which would require Aldeyra to expend more resources than Aldeyra planned or that are available to Aldeyra, and could substantially delay acceptance and/or approval, if any, of a potential NDA resubmission. Any such requirement would increase Aldeyra’s costs and delay approval and commercialization of reproxalap for the treatment of dry eye disease and would have a material adverse effect on Aldeyra’s business and financial condition.
Even if reproxalap is approved for the treatment of dry eye disease, the FDA may limit use to certain patient populations, include extensive warnings on the product labeling, or require costly ongoing requirements for post-marketing clinical studies and surveillance or other risk management measures to monitor the safety or efficacy of reproxalap.
Any regulatory approval of reproxalap, once obtained, may be withdrawn. Ultimately, the failure to obtain and maintain regulatory approvals would prevent reproxalap from being marketed and would have a material adverse effect on Aldeyra’s business.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements, including statements regarding the outcome and expected timing of discussions with the FDA; the FDA’s potential acceptance and/or approval of a potential NDA resubmission for reproxalap; the adequacy of the data of the ongoing trials or other additional studies or clinical trials conducted in connection with a potential NDA resubmission; a potential NDA resubmission or the supplemental responses to the FDA; and the Company’s ability to successfully commercialize (alone or with others) reproxalap. Any statements about the Company’s expectations, beliefs, plans, predictions, forecasts, objectives, assumptions, or future events or performance are not historical facts and may be forward-looking. These statements are often, but not always, made through the use of words or phrases such as “anticipates,” “believes,” “can,” “could,” “may,” “predicts,” “potential,” “should,” “will,” “estimate,” “plans,” “projects,” “continuing,” “ongoing,” “expects,” “intends,” and similar words or phrases. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, these statements are not guarantees of future performance and involve risks and uncertainties which are subject to change based on various important factors, some of which are beyond the Company’s control. The Company has based these forward-looking statements largely on its current expectations and projections about future events and financial trends that it believes may affect its business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Current Report on Form 8-K and are subject to a number of risks, uncertainties and assumptions including, without limitation, risks and factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, which is on file with the SEC and available on the SEC’s website at www.sec.gov. Additional factors may be described in those sections of Aldeyra’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, expected to be filed with the SEC in the second quarter of 2025. The Company does not undertake any obligation to update any forward-looking statements made in this Current Report on Form 8-K as a result of new information, future events or otherwise.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Aldeyra Therapeutics, Inc. Presentation dated April 3, 2025 | |
| 99.2 | Aldeyra Therapeutics, Inc. Press Release dated April 3, 2025 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
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 April 3, 2025