Clinical Trial Results and Potential New Drug Application Resubmission Expected in the Second Half of 2024
LEXINGTON, Mass., June 13, 2024--(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 completion of enrollment in a Phase 3 dry eye chamber clinical trial of topical ocular 0.25% reproxalap, an investigational RASP modulator, for the treatment of dry eye disease. The trial is designed to enable potential resubmission of a dry eye disease New Drug Application (NDA) in the second half of 2024.
In the clinical trial, a total of 132 patients were enrolled to assess the primary endpoint of ocular discomfort. Initiation of enrollment was announced in May 2024. In four previously completed dry eye chamber clinical trials of reproxalap, when analyzed in aggregate with the trial design and statistical plan discussed with the U.S. Food and Drug Administration (FDA), ocular discomfort in the dry eye chamber following treatment with reproxalap was statistically lower than that of vehicle (p=0.0003).
"We believe the rapid enrollment of the Phase 3 clinical trial is consistent with the unmet medical need that exists for patients suffering from dry eye disease," stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. "We anticipate receiving results from the clinical trial in the third quarter of 2024, and, contingent on positive results, we remain on track to resubmit the dry eye disease NDA for reproxalap in the second half of 2024."
Aldeyra intends to include in the potential NDA resubmission a draft label for reproxalap describing chronic and acute improvement in symptoms and ocular redness. To Aldeyra’s knowledge, if approved, the draft label could represent the first dry eye disease label that incorporates clinical data assessed acutely in a dry eye chamber, and potentially the first dry eye disease label that includes reduction in ocular redness for a chronically administered drug. Per FDA guidance, the review period for the potential NDA resubmission is expected to be six months.
A Phase 3 clinical trial of reproxalap at a different dry eye chamber, in addition to a traditional six-week field clinical trial, are being conducted in parallel as part of a comprehensive strategy designed to account for disease heterogeneity and potential differences in clinical sites and environment.
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-246, ADX-248, and chemically related molecules for the potential treatment of 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 expected timing and the results of Aldeyra’s planned clinical trials, including planned and ongoing clinical trials for reproxalap; the outcome and timing of the FDA’s review, acceptance and/or approval of a NDA resubmission for reproxalap and the adequacy of the data included in the original NDA and the potential NDA resubmission; and Aldeyra’s expectations regarding the labeling of reproxalap, if approved. 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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.