Aldeyra Therapeutics Enrolls First Patient in Phase 3 Clinical Trial Designed to Enable Potential Resubmission of New Drug Application of Reproxalap in Dry Eye Disease

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 enrollment of the first patient in a Phase 3 dry eye chamber clinical trial designed to enable a potential resubmission of the New Drug Application (NDA) of topical ocular 0.25% reproxalap, an investigational RASP modulator, for the treatment of dry eye disease.

Contingent on positive results from the clinical trial, Aldeyra expects to resubmit the NDA of reproxalap for the treatment of dry eye disease to the U.S. Food and Drug Administration (FDA) in the second half of 2024. Aldeyra intends to include in the potential NDA resubmission a draft label describing chronic and acute improvement in symptoms and ocular redness. To Aldeyra’s knowledge, 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 planned review period for the potential NDA resubmission is expected to be six months.

In the clinical trial, patients are administered vehicle (the drug product without the active ingredient) before and during exposure to a dry eye chamber. Qualifying patients are subsequently randomized to receive either reproxalap or vehicle before and during exposure to an additional dry eye chamber. Approximately 110 patients are expected to be enrolled to assess the primary endpoint of ocular discomfort. In four previously completed dry eye chamber clinical trials of reproxalap, when analyzed in aggregate with the trial design and statistical plan recently discussed with the FDA, ocular discomfort in the dry eye chamber following treatment with reproxalap was statistically lower than that of vehicle (p=0.0003).

A clinical trial at a different dry eye chamber, in addition to a traditional six-week field clinical trial, are expected to be conducted in parallel as part of a comprehensive strategy designed to account for disease heterogeneity and potential differences in clinical sites and environment. Consistent with previously disclosed guidance and based on the current operating plan, cash, cash equivalents, and marketable securities of $133.0 million as of March 31, 2024 are projected to be sufficient to fund operations to beyond the end of 2026.