Aldeyra Therapeutics, Inc. filed a Form 8-K on November 9, 2026, disclosing that it has formally requested a review jurisdiction transfer for its ADX-2191 Investigational New Drug application and has withdrawn the previously agreed Special Protocol Assessment protocol for the treatment of primary vitreoretinal lymphoma.

Key Highlights

  • Jurisdiction transfer requested: Aldeyra asked the FDA's Division of Ophthalmology to submit a review jurisdiction request to the Office of New Drugs recommending transfer of the ADX-2191 IND to the Division of Hematologic Malignancies 2 (DHM2).
  • SPA withdrawn: In connection with the transfer request, Aldeyra notified the FDA that it had withdrawn the Special Protocol Assessment protocol for ADX-2191 in primary vitreoretinal lymphoma, which the Division of Ophthalmology had previously reviewed and agreed to.
  • Clinical trial on hold: According to the filing, while the jurisdictional request is pending, the company does not expect to initiate the clinical trial contemplated by the SPA.
  • Prior Complete Response Letter: The filing states that in June 2023 the company received a Complete Response Letter for its ADX-2191 New Drug Application citing a lack of substantial evidence of effectiveness due to a lack of adequate and well-controlled investigations.
  • Regulatory outcome uncertain: The filing discloses that the DO's submission of the request and the OND's decision are each within the respective body's own discretion, and the OND may deny the request or transfer the IND to a division other than DHM2.
  • Potential downstream risks identified: The company disclosed that any redesigned trial may be larger, longer, or more costly, and could delay or prevent orphan drug exclusivity for ADX-2191 in PVRL.

Aldeyra Discloses ADX-2191 Regulatory Realignment and SPA Withdrawal

In the 8-K filed with the SEC on November 9, 2026, Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) disclosed that it formally requested that the FDA's Division of Ophthalmology submit a review jurisdiction request to the Office of New Drugs, recommending that oversight of the ADX-2191 IND for primary vitreoretinal lymphoma be transferred to the Division of Hematologic Malignancies 2. According to the filing, Aldeyra made this request because "lymphoma reviews are typically conducted by DHM2, which maintains expertise in local and systemic manifestations of hematogenous cancers."

Simultaneously, the company notified the FDA that it had withdrawn the SPA protocol that the Division of Ophthalmology had previously reviewed and agreed to. The filing notes that as a result, Aldeyra "will no longer have the benefit of the DO's agreement on the design and planned analysis of the trial." The filing further states that the submission of the jurisdiction request is within the DO's control, and any decision on the request is within the FDA's discretion. The company disclosed it cannot predict whether or when the DO will submit the request, what the DO will recommend, or when the OND will act.

The filing identifies several risk scenarios: if the IND remains with the DO, the withdrawal of the SPA and the transfer request "could adversely affect the DO's review of ADX-2191"; if the IND is transferred, the receiving division will not be bound by prior agreements or positions of the DO and may require different or additional trials, data, or analyses. The company also referenced that the FDA had previously recommended trials for ADX-2191 for the treatment of proliferative vitreoretinopathy that the company "did not deem feasible, which led us to cease development in that indication," and stated a similar conclusion regarding PVRL is possible. The filing states these outcomes "could delay or prevent an NDA resubmission for, or approval of, ADX-2191 in PVRL; increase our costs; shorten our projected cash runway; require us to raise additional capital sooner than expected."

What Was Disclosed

Aldeyra Therapeutics disclosed a formal FDA review jurisdiction transfer request for ADX-2191 in primary vitreoretinal lymphoma, the simultaneous withdrawal of its previously agreed SPA protocol, and an updated risk factor describing the resulting uncertainty in the regulatory and clinical development path.